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1.  Analysis of Efficacy Differences between Caudal and Lumbar Interlaminar Epidural Injections in Chronic Lumbar Axial Discogenic Pain: Local Anesthetic Alone vs. Local Combined with Steroids 
Study Design: Comparative assessment of randomized controlled trials of caudal and lumbar interlaminar epidural injections in chronic lumbar discogenic pain.
Objective: To assess the comparative efficacy of caudal and lumbar interlaminar approaches of epidural injections in managing axial or discogenic low back pain.
Summary of Background Data: Epidural injections are commonly performed utilizing either a caudal or lumbar interlaminar approach to treat chronic lumbar axial or discogenic pain, which is pain exclusive of that associated with a herniated intervertebral disc, or that is due to degeneration of the zygapophyseal joints, or due to dysfunction of the sacroiliac joints, respectively. The literature on the efficacy of epidural injections in managing chronic axial lumbar pain of presumed discogenic origin is limited.
Methods: The present analysis is based on 2 randomized controlled trials of chronic axial low back pain not caused by disc herniation, radiculitis, or facet joint pain, utilizing either a caudal or lumbar interlaminar approach, with a total of 240 patients studied, and a 24-month follow-up. Patients were assigned to receive either local anesthetic only or local anesthetic with a steroid in each 60 patient group.
Results: The primary outcome measure was significant improvement, defined as pain relief and functional status improvement of at least 50% from baseline, which was reported at 24-month follow-ups in 72% who received local anesthetic only with a lumbar interlaminar approach and 54% who received local anesthetic only with a caudal approach. In patients receiving local anesthetic with a steroid, the response rate was 67% for those who had a lumbar interlaminar approach and 68% for those who had a caudal approach at 12 months. The response was significantly better in the lumbar interlaminar group who received local anesthetic only, 77% versus 56% at 12 months and 72% versus 54% at 24 months.
Conclusion: This assessment shows that in patients with axial or discogenic pain in the lumbar spine after excluding facet joint and SI Joint pain, epidural injections of local anesthetic by the caudal or lumbar interlaminar approach may be effective in managing chronic low back pain with a potential superiority for a lumbar interlaminar approach over a caudal approach.
doi:10.7150/ijms.10870
PMCID: PMC4323359
Chronic low back pain; axial low back pain; lumbar discogenic pain; caudal epidural injections; lumbar interlaminar epidural injections.
2.  Two-Year Follow-Up Results of Fluoroscopic Cervical Epidural Injections in Chronic Axial or Discogenic Neck Pain: A Randomized, Double-Blind, Controlled Trial 
Study Design: A randomized, double-blind, active-controlled trial.
Objective: To assess the effectiveness of cervical interlaminar epidural injections of local anesthetic with or without steroids for the management of axial or discogenic pain in patients without disc herniation, radiculitis, or facet joint pain.
Summary of Background Data: Cervical discogenic pain without disc herniation is a common cause of suffering and disability in the adult population. Once conservative management has failed and facet joint pain has been excluded, cervical epidural injections may be considered as a management tool. Despite a paucity of evidence, cervical epidural injections are one of the most commonly performed nonsurgical interventions in the management of chronic axial or disc-related neck pain.
Methods: One hundred and twenty patients without disc herniation or radiculitis and negative for facet joint pain as determined by means of controlled diagnostic medial branch blocks were randomly assigned to one of the 2 treatment groups. Group I patients received cervical interlaminar epidural injections of local anesthetic (lidocaine 0.5%, 5 mL), whereas Group II patients received 0.5% lidocaine, 4 mL, mixed with 1 mL or 6 mg of nonparticulate betamethasone.
The primary outcome measure was ≥ 50% improvement in pain and function. Outcome assessments included numeric rating scale (NRS), Neck Disability Index (NDI), opioid intake, employment, and changes in weight.
Results: Significant pain relief and functional improvement (≥ 50%) was present at the end of 2 years in 73% of patients receiving local anesthetic only and 70% receiving local anesthetic with steroids. In the successful group of patients, however, defined as consistent relief with 2 initial injections of at least 3 weeks, significant improvement was illustrated in 78% in the local anesthetic group and 75% in the local anesthetic with steroid group at the end of 2 years. The results reported at the one-year follow-up were sustained at the 2-year follow-up.
Conclusions: Cervical interlaminar epidural injections with or without steroids may provide significant improvement in pain and functioning in patients with chronic discogenic or axial pain that is function-limiting and not related to facet joint pain.
doi:10.7150/ijms.8069
PMCID: PMC3936024  PMID: 24578607
Chronic neck pain; cervical discogenic pain; cervical axial pain; cervical disc herniation; cervical epidural injections; epidural steroids; local anesthetics.
3.  Fluoroscopic caudal epidural injections in managing chronic axial low back pain without disc herniation, radiculitis, or facet joint pain 
Journal of Pain Research  2012;5:381-390.
Background
Chronic low back pain without disc herniation is common. Various modalities of treatments are utilized in managing this condition, including epidural injections. However, there is continued debate on the effectiveness, indications, and medical necessity of any treatment modality utilized for managing axial or discogenic pain, including epidural injections.
Methods
A randomized, double-blind, actively controlled trial was conducted. The objective was to evaluate the ability to assess the effectiveness of caudal epidural injections of local anesthetic with or without steroids for managing chronic low back pain not caused by disc herniation, radiculitis, facet joints, or sacroiliac joints. A total of 120 patients were randomized to two groups; one group did not receive steroids (group 1) and the other group did (group 2). There were 60 patients in each group. The primary outcome measure was at least 50% improvement in Numeric Rating Scale and Oswestry Disability Index. Secondary outcome measures were employment status and opioid intake. These measures were assessed at 3, 6, 12, 18, and 24 months after treatment.
Results
Significant pain relief and functional status improvement (primary outcome) defined as a 50% or more reduction in scores from baseline, were observed in 54% of patients in group 1 and 60% of patients in group 2 at 24 months. In contrast, 84% of patients in group 1 and 73% in group 2 saw significant pain relief and functional status improvement in the successful groups at 24 months.
Conclusion
Caudal epidural injections of local anesthetic with or without steroids are effective in patients with chronic axial low back pain of discogenic origin without facet joint pain, disc herniation, and/or radiculitis.
doi:10.2147/JPR.S35924
PMCID: PMC3474158  PMID: 23091395
chronic axial low back pain; discogenic pain; disc herniation; caudal epidural injections
4.  Fluoroscopic cervical epidural injections in chronic axial or disc-related neck pain without disc herniation, facet joint pain, or radiculitis 
Journal of Pain Research  2012;5:227-236.
Background
While chronic neck pain is a common problem in the adult population, with a typical 12-month prevalence of 30%–50%, there is a lack of consensus regarding its causes and treatment. Despite limited evidence, cervical epidural injections are one of the commonly performed nonsurgical interventions in the management of chronic neck pain.
Methods
A randomized, double-blind, active, controlled trial was conducted to evaluate the effectiveness of cervical interlaminar epidural injections of local anesthetic with or without steroids for the management of chronic neck pain with or without upper extremity pain in patients without disc herniation, radiculitis, or facet joint pain.
Results
One hundred and twenty patients without disc herniation or radiculitis and negative for facet joint pain by means of controlled diagnostic medial branch blocks were randomly assigned to one of two treatment groups, ie, injection of local anesthetic only (group 1) or local anesthetic mixed with nonparticulate betamethasone (group 2). The primary outcome of significant pain relief and improvement in functional status (≥50%) was demonstrated in 72% of group 1 and 68% of group 2. The overall average number of procedures per year was 3.6 in both groups with an average total relief per year of 37–39 weeks in the successful group over a period of 52 weeks.
Conclusion
Cervical interlaminar epidural injections of local anesthetic with or without steroids may be effective in patients with chronic function-limiting discogenic or axial pain.
doi:10.2147/JPR.S32692
PMCID: PMC3401988  PMID: 22826642
chronic neck pain; cervical disc herniation; cervical discogenic pain; cervical epidural injections; epidural steroids; local anesthetics
5.  Management of Chronic Pain of Cervical Disc Herniation and Radiculitis with Fluoroscopic Cervical Interlaminar Epidural Injections 
Study Design: A randomized, double-blind, active controlled trial.
Objective: To evaluate the effectiveness of cervical interlaminar epidural injections of local anesthetic with or without steroids in the management of chronic neck pain and upper extremity pain in patients with disc herniation and radiculitis.
Summary of Background Data: Epidural injections in managing chronic neck and upper extremity pain are commonly employed interventions. However, their long-term effectiveness, indications, and medical necessity, of their use and their role in various pathologies responsible for persistent neck and upper extremity pain continue to be debated, even though, neck and upper extremity pain secondary to disc herniation and radiculitis, is described as the common indication. There is also paucity of high quality literature.
Methods: One-hundred twenty patients were randomly assigned to one of 2 groups: Group I patients received cervical interlaminar epidural injections of local anesthetic (lidocaine 0.5%, 5 mL); Group II patients received 0.5% lidocaine, 4 mL, mixed with 1 mL of nonparticulate betamethasone.
Primary outcome measure was ≥ 50 improvement in pain and function. Outcome assessments included Numeric Rating Scale (NRS), Oswestry Disability Index (ODI), opioid intake, employment, and changes in weight.
Results: Significant pain relief and functional status improvement (≥ 50%) was demonstrated in 72% of patients who received local anesthetic only and 68% who received local anesthetic and steroids. In the successful group of participants, significant improvement was illustrated in 77% in local anesthetic group and 82% in local anesthetic with steroid group.
Conclusions: Cervical interlaminar epidural injections with or without steroids may provide significant improvement in pain and function for patients with cervical disc herniation and radiculitis.
doi:10.7150/ijms.4444
PMCID: PMC3410361  PMID: 22859902
Chronic neck pain; cervical disc herniation; upper extremity pain; cervical epidural injections; epidural steroids; local anesthetics
6.  Radiofrequency ablation for chronic low back pain: A systematic review of randomized controlled trials 
Low back pain affects a considerable proportion of the population and can significantly decrease quality of life. Radiofrequency ablation is an emerging technique that may offer relief from pain for patients experiencing chronic low back pain. This systematic review of the procedure aimed to summarize its efficacy in the treatment of pain in different regions of the low back.
BACKGROUND:
Radiofrequency ablation (RFA), a procedure using heat to interrupt pain signals in spinal nerves, is an emerging treatment option for chronic low back pain. Its clinical efficacy has not yet been established.
OBJECTIVE:
To determine the efficacy of RFA for chronic low back pain associated with lumbar facet joints, sacroiliac joints, discogenic low back pain and the coccyx.
METHODS:
A systematic review was conducted. Medline, EMBASE, PubMed, SPORTDiscus, CINAHL and the Cochrane Library were searched up to August 2013. Abstracts and full-text articles were reviewed in duplicate. Included articles were sham-controlled randomized controlled trials (RCTs), assessed the efficacy of RFA, reported at least one month of follow-up and included participants who had experienced back pain for at least three months. Data were extracted in duplicate and quality was assessed using the Cochrane Risk of Bias tool. Due to heterogeneity, as well as a lack of reported mean differences and SDs, meta-analysis was not possible using these data.
RESULTS:
The present systematic review retrieved 1063 abstracts. Eleven sham-controlled RCTs were included: three studies involving discogenic back pain; six studies involving lumbar facet joint pain; and two studies involving sacroiliac joint pain. No studies were identified assessing the coccyx. The evidence supports RFA as an efficacious treatment for lumbar facet joint and sacroiliac joint pain, with five of six and both of the RCTs demonstrating statistically significant pain reductions, respectively. The evidence supporting RFA for the treatment of discogenic pain is mixed.
CONCLUSIONS:
While the majority of the studies focusing on lumbar facet joints and sacroiliac joints suggest that RFA significantly reduces pain in short-term follow-up, the evidence base for discogenic low back pain is mixed. There is no RCT evidence for RFA for the coccyx. Future studies should examine the clinical significance of the achieved pain reduction and the long-term efficacy of RFA.
PMCID: PMC4197759  PMID: 25068973
Chronic low back pain; Low back pain; Radiofrequency ablation; Visual analogue scale
7.  Assessment of Effectiveness of Percutaneous Adhesiolysis in Managing Chronic Low Back Pain Secondary to Lumbar Central Spinal Canal Stenosis 
Background: Chronic persistent low back and lower extremity pain secondary to central spinal stenosis is common and disabling. Lumbar surgical interventions with decompression or fusion are most commonly performed to manage severe spinal stenosis. However, epidural injections are also frequently performed in managing central spinal stenosis. After failure of epidural steroid injections, the next sequential step is percutaneous adhesiolysis and hypertonic saline neurolysis with a targeted delivery. The literature on the effectiveness of percutaneous adhesiolysis in managing central spinal stenosis after failure of epidural injections has not been widely studied.
Study Design: A prospective evaluation.
Setting: An interventional pain management practice, a specialty referral center, a private practice setting in the United States.
Objective: To evaluate the effectiveness of percutaneous epidural adhesiolysis in patients with chronic low back and lower extremity pain with lumbar central spinal stenosis.
Methods: Seventy patients were recruited. The initial phase of the study was randomized, double-blind with a comparison of percutaneous adhesiolysis with caudal epidural injections. The 25 patients from the adhesiolysis group continued with follow-up, along with 45 additional patients, leading to a total of 70 patients. All patients received percutaneous adhesiolysis and appropriate placement of the Racz catheter, followed by an injection of 5 mL of 2% preservative-free lidocaine with subsequent monitoring in the recovery room. In the recovery room, each patient also received 6 mL of 10% hypertonic sodium chloride solution, and 6 mg of non-particulate betamethasone, followed by an injection of 1 mL of sodium chloride solution and removal of the catheter.
Outcomes Assessment: Multiple outcome measures were utilized including the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake with assessment at 3, 6, and 12, 18 and 24 months post treatment. The primary outcome measure was 50% or more improvement in pain scores and ODI scores.
Results: Overall, a primary outcome or significant pain relief and functional status improvement of 50% or more was seen in 71% of patients at the end of 2 years. The overall number of procedures over a period of 2 years were 5.7 ± 2.73.
Limitations: The lack of a control group and a prospective design.
Conclusions: Significant relief and functional status improvement as seen in 71% of the 70 patients with percutaneous adhesiolysis utilizing local anesthetic steroids and hypertonic sodium chloride solution may be an effective management strategy in patients with chronic function limiting low back and lower extremity pain with central spinal stenosis after failure of conservatie management and fluoroscopically directed epidural injections.
doi:10.7150/ijms.5303
PMCID: PMC3534877  PMID: 23289005
Central spinal stenosis; percutaneous adhesiolysis; steroids; local anesthetics; hypertonic sodium chloride solution
8.  Fluoroscopic Caudal Epidural Injections in Managing Post Lumbar Surgery Syndrome: Two-Year Results of a Randomized, Double-Blind, Active-Control Trial 
Study Design: A randomized, active control, double-blind trial. Objective: To evaluate the effectiveness of fluoroscopically directed caudal epidural injections with or without steroids in managing chronic low back and lower extremity pain secondary to post lumbar surgery syndrome. Summary of Background Data: There is a paucity of evidence concerning caudal epidural injections for managing chronic persistent low back pain with or without lower extremity pain caused by post lumbar surgery syndrome.
Methods: This active control randomized study included 140 patients with 70 patients in each group. Group I received 0.5% lidocaine, 10 mL; Group II received 9 mL of 0.5% lidocaine mixed with 1 mL of 6 mg of nonparticulate betamethasone. The multiple outcome measures included the numeric rating scale, the Oswestry Disability Index 2.0, employment status, and opioid intake with assessments at 3, 6, 12, 18, and 24 months posttreatment. Primary outcome was defined as at least 50% improvement in pain and Oswestry Disability Index scores. Patients with a positive response to the first 2 procedures with at least 3 weeks of relief were considered to be successful. All others were considered as failures.
Results: Overall in Group I, 53% and 47% of the patients and in Group II, 59% and 58% of the patients, showed significant improvement with reduction in pain scores and disability index at 12 months and 24 months. In contrast, in the successful groups, significant pain relief and improvement in function were observed in 70% and 62% of Group I at one and 2 years; in 75% and 69% of Group II at one and 2 years. The results in the successful group showed that at the end of the first year patients experienced approximately 38 weeks of relief and at the end of 2 years Group I had 62 weeks and Group II had 68 weeks of relief. Overall total relief for 2 years was 48 weeks in Group I and 54 weeks in Group II. The average procedures in the successful groups were at 4 in one year and 6 at the end of 2 years.
Conclusion: Caudal epidural injections of local anesthetic with or without steroid might be effective in patients with chronic persistent low back and/or lower extremity pain in patients with post lumbar surgery syndrome.
doi:10.7150/ijms.4672
PMCID: PMC3461763  PMID: 23028241
Chronic low back pain; post lumbar surgery syndrome; recurrent disc herniation; epidural fibrosis; spinal stenosis; caudal epidural steroid injections.
9.  Evaluation of Lumbar Facet Joint Nerve Blocks in Managing Chronic Low Back Pain: A Randomized, Double-Blind, Controlled Trial with a 2-Year Follow-Up 
Study Design: A randomized, double-blind, controlled trial.
Objective: To determine the clinical effectiveness of therapeutic lumbar facet joint nerve blocks with or without steroids in managing chronic low back pain of facet joint origin.
Summary of Background Data: Lumbar facet joints have been shown as the source of chronic pain in 21% to 41% of low back patients with an average prevalence of 31% utilizing controlled comparative local anesthetic blocks. Intraarticular injections, medial branch blocks, and radiofrequency neurotomy of lumbar facet joint nerves have been described in the alleviation of chronic low back pain of facet joint origin.
Methods: The study included 120 patients with 60 patients in each group with local anesthetic alone or local anesthetic and steroids. The inclusion criteria was based upon a positive response to diagnostic controlled, comparative local anesthetic lumbar facet joint blocks.
Outcome measures included the numeric rating scale (NRS), Oswestry Disability Index (ODI), opioid intake, and work status, at baseline, 3, 6, 12, 18, and 24 months.
Results: Significant improvement with significant pain relief of ≥ 50% and functional improvement of ≥ 40% were observed in 85% in Group 1, and 90% in Group II, at 2-year follow-up.
The patients in the study experienced significant pain relief for 82 to 84 weeks of 104 weeks, requiring approximately 5 to 6 treatments with an average relief of 19 weeks per episode of treatment.
Conclusions: Therapeutic lumbar facet joint nerve blocks, with or without steroids, may provide a management option for chronic function-limiting low back pain of facet joint origin.
PMCID: PMC2880841  PMID: 20567613
Chronic low back pain; lumbar facet or zygapophysial joint pain; facet joint nerve or medial branch blocks; comparative controlled local anesthetic blocks; therapeutic lumbar facet joint nerve blocks
10.  Intradiscal methylene blue injection for the treatment of chronic discogenic low back pain 
European Spine Journal  2006;16(1):33-38.
This article was a preliminary report of prospective clinical trial of a group of patients with chronic discogenic low back pain who met the criteria for lumbar interbody fusion surgery but were treated instead with an intradiscal injection of methylene blue (MB) for the pain relief. Twenty-four patients with chronic discogenic low back pain underwent diagnostic discography with intradiscal injection of MB. The principal criteria to judge the effectiveness included alleviation of pain, assessed by visual analog scale (VAS), and improvement in disability, as assessed with the Oswestry Disability Index (ODI) for functional recovery. The mean follow-up period was 18.2 months (range 12–23 months). Of the 24 patients, 21 (87%) reported a disappearance or marked alleviation of low back pain, and experienced a definite improvement in physical function. A statistically significant and clinically meaningful improvement in the changes in the ODI and the VAS scores were obtained in the patients with chronic discogenic low back pain (P=0.0001) after the treatment. The study suggests that the injection of MB into the painful disc may be a very effective alternative for the surgical treatment of chronic discogenic low back pain.
doi:10.1007/s00586-006-0076-1
PMCID: PMC2198898  PMID: 16496191
Discogenic low back pain; Discography; Methylene blue; Injection
11.  Low back pain (chronic) 
Clinical Evidence  2010;2010:1116.
Introduction
Over 70% of people in developed countries develop low back pain (LBP) at some time. But recovery is not always favourable: 82% of non recent-onset patients still experience pain 1 year later. Many patients with chronic LBP who were initially told that their natural history was good spend months or years seeking relief.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of oral drug treatments? What are the effects of injection therapy? What are the effects of non-drug treatments? What are the effects of non-surgical and surgical treatments? We searched: Medline, Embase, The Cochrane Library, and other important databases up to April 2009 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 64 systematic reviews or RCTs that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review, we present information relating to the effectiveness and safety of the following interventions: acupuncture, analgesics, antidepressants, back schools, behavioural therapy, electromyographic biofeedback, exercise, injections (epidural corticosteroid injections, facet joint injections, local injections), intensive multidisciplinary treatment programmes, lumbar supports, massage, muscle relaxants, non-steroidal anti-inflammatory drugs (NSAIDs), non-surgical interventional therapies (intradiscal electrothermal therapy, radiofrequency denervation), spinal manipulative therapy, surgery, traction, and transcutaneous electrical nerve stimulation (TENS).
Key Points
Over 70% of people in developed countries develop low back pain at some time, which usually improves within 2 weeks, however about 10% remained off work and about 20% had persistent symptoms at 1 year.
Non-steroidal anti-inflammatory drugs (NSAIDs) may be more effective than placebo at improving pain intensity in people with chronic low back pain.
Opioid analgesics (with or without paracetamol) may improve pain and function compared with placebo. However, long-term use of NSAIDs or opioids may be associated with well-recognised adverse effects. We don't know whether antidepressants decrease chronic low back pain or improve function compared with placebo in people with or without depression. Benzodiazepines may improve pain, but studies of non-benzodiazepine muscle relaxants have given conflicting results.
CAUTION: Since the last update of this review, a drug safety alert has been issued on increased suicidal behaviour with antidepressants (www.fda.gov/medwatch).
We don't know whether epidural corticosteroid injections or local injections with corticosteroids and local anaesthetic improve chronic low back pain in people without sciatica. Facet-joint corticosteroid injections may be no more effective than placebo at reducing pain.
Fusion surgery is more effective than standard rehabilitation for improving pain in people with chronic non-radicular low back pain, but it is no better than intensive rehabilitation with a cognitive behavioural component.
Exercise improves pain and function compared with other conservative treatments.
Intensive multidisciplinary treatment programmes improve pain and function compared with usual care, but less-intensive programmes do not seem beneficial.
Acupuncture, back schools, behavioural therapy, and spinal manipulation may reduce pain in the short term, but effects on function are unclear.
Massage may improve pain and function compared with sham or other active treatment.
We don't know whether electromyographic biofeedback, lumbar supports, traction, or TENS improve pain relief.
We also don't know whether intradiscal electrothermal therapy, radiofrequency denervation, or disc replacement improve pain relief or function.
PMCID: PMC3217809  PMID: 21418678
12.  Assessment of effectiveness of percutaneous adhesiolysis and caudal epidural injections in managing post lumbar surgery syndrome: 2-year follow-up of a randomized, controlled trial 
Journal of Pain Research  2012;5:597-608.
Background
The literature is replete with evaluations of failed surgery, illustrating a 9.5%–25% reoperation rate. Speculated causes of post lumbar surgery syndrome include epidural fibrosis, acquired stenosis, recurrent disc herniation, sacroiliac joint pain, and facet joint pain among other causes.
Methods
Patients (n = 120) were randomly assigned to two groups with a 2-year follow-up. Group I (control group, n = 60) received caudal epidural injections with catheterization up to S3 with local anesthetic (lidocaine 2%, 5 mL), nonparticulate betamethasone (6 mg, 1 mL), and 6 mL of 0.9% sodium chloride solution. Group II (intervention group, n = 60) received percutaneous adhesiolysis of the targeted area, with targeted delivery of lidocaine 2% (5 mL), 10% hypertonic sodium chloride solution (6 mL), and nonparticulate betamethasone (6 mg). The multiple outcome measures included the Numeric Rating Scale, the Oswestry Disability Index 2.0, employment status, and opioid intake with assessments at 3, 6, 12, 18, and 24 months posttreatment. Primary outcome was defined as 50% improvement in pain and Oswestry Disability Index scores.
Results
Significant improvement with at least 50% relief with pain and improvement in functional status was illustrated in 82% of patients at the 2-year follow-up in the intervention group compared to 5% in the control group receiving caudal epidural injections. The average number of procedures over a period of 2 years in Group II was 6.4 ± 2.35 with overall total relief of approximately 78 weeks out of 104 weeks.
Conclusion
The results of this study show significant improvement in 82% of patients over a period of 2 years with an average of six to seven procedures of 1-day percutaneous adhesiolysis in patients with failed back surgery syndrome.
doi:10.2147/JPR.S38999
PMCID: PMC3533727  PMID: 23293536
epidural adhesions; epidural steroid injections; epidural fibrosis
13.  Discogenic pain in acute nonspecific low-back pain 
European Spine Journal  2005;14(6):573-577.
Acute nonspecific low-back pain is characterized by the sudden onset and severe unendurable low-back pain without radicular pain or neurological deficit in the lower extremities. The study was carried out using 55 patients who visited our hospital for acute nonspecific low-back pain, who exhibited degeneration on T2-weighted MR images, and underwent intradiscal injection of local anesthetics,steroid and contrast medium. Intervertebral disc sites with an obvious enhanced region in the posterior annulus of the disc on enhanced T1-weghted MR images was selected for intradiscal injection. When no enhaced region was detected, the most severely degenerated disc on T2-weighted MR images was selected. Acute nonspecific low-back pain with an improvement rate of 70% or higher 5min after injection was judged to be discogenic. The clinical characteristics and pathogenesis of discogenic acute nonspecific low-back pain were investigated. Forty of the 55 patients (73%) had discogenic acute nonspecific low-back pain. As for the characteristics of patients, the mean age was 37 years, and onset occurred upon casual daily movements in 18 patients (45%). Nineteen patients (48%) had bilateral low-back pain, and 29 patients (73%) had no tenderness in the paravertebral muscles. On plain X-ray radiograms, degeneration of the disc was normal or mild in 36 patients(91%). On the discograms, a radial tear extending to the posterior annulus was noted in all patients, but epidural leakage was seen only in six patients (15%). The degree of disc degeneration on T2-weighted MR images (Gibson’s classification) was grade 3 in 30 patients (75%). Gadolinium-DTPA enhanced T1-weighted MR images showed an obvious enhanced region in the posterior annulus of the intervertebral disc in 19 patients (48%). As for the clinical characteristics of discogenic acute nonspecific low-back pain, the relatively young adult patients had no tenderness in the paravertebral muscles, and showed moderately degererated intervertebral discs. The pathogenesis of discogenic acute nonspecific low-back pain is mostly considered to be a re-rupture in an asymptomatic ruputured region in the posterior annulus, repaired by granulation tissue, in a moderately degenerated intervertebral disc with a radial tear.
doi:10.1007/s00586-004-0844-8
PMCID: PMC3489234  PMID: 15668774
Discogenic pain; Acute low-back pain; Acute nonspecific low-back pain
14.  Low back pain (chronic) 
Clinical Evidence  2008;2008:1116.
Introduction
Over 70% of people in resource-rich countries develop low back pain (LBP) at some time. But recovery is not always favourable: 82% of non-recent-onset patients still experience pain one year later. Many chronic patients who were initially told that their natural history was good spend months or years seeking relief.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of oral drug treatments? What are the effects of injection therapy? What are the effects of non-drug treatments? We searched: Medline, Embase, The Cochrane Library, and other important databases up to May 2007 (BMJ Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 74 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review, we present information relating to the effectiveness and safety of the following interventions: acupuncture, analgesics, antidepressants, back schools, behavioural therapy, electromyographic biofeedback, exercise, injections (epidural steroid injections, facet joint injections, local injections), intensive multidisciplinary treatment programmes, lumbar supports, massage, muscle relaxants, non-steroidal anti-inflammatory drugs (NSAIDs), spinal manipulative therapy, traction, and transcutaneous electrical nerve stimulation (TENS).
Key Points
Over 70% of people in resource-rich countries develop low back pain at some time, which usually improves within 2 weeks, but up to 7% of affected people develop chronic low back pain.
Opioid analgesics, with or without paracetamol, and NSAIDs may improve pain and function compared with placebo. Antidepressants decrease chronic low back pain compared with placebo in people with or without depression, but their effects on function are unclear. Muscle relaxants may improve pain, but studies have given conflicting results.
CAUTION: Since the last update of this review, a drug safety alert has been issued on increased suicidal behaviour with antidepressants, and on major congenital malformations with paroxetine (www.fda.gov/medwatch).
We don't know whether epidural steroid injections or local injections with corticosteroids and local anaesthetic improve chronic low back pain in people without sciatica. Facet joint corticosteroid injections may be no more effective than placebo at reducing pain.
Exercise improves pain and function compared with other conservative treatments. Intensive multidisciplinary treatment programmes improve pain and function compared with usual care, but less-intensive programmes do not seem to be beneficial. Acupuncture, back schools, behavioural therapy, and spinal manipulation may reduce pain in the short term, but we don't know how they compare with other active treatments.We don't know whether electromyographic biofeedback, lumbar supports, massage, traction, or TENS improve pain relief.
PMCID: PMC2908004  PMID: 19445791
15.  Low back pain (acute) 
Clinical Evidence  2008;2008:1102.
Introduction
Low back pain (LBP) affects about 70% of people in resource-rich countries at some point. Acute low back pain is usually perceived as self-limiting; however, one year later, as many as 33% of people still have moderate-intensity pain and 15% have severe pain. It has a high recurrence rate; 75% of those with a first episode have a recurrence. Although acute episodes may resolve completely, they may also increase in severity and duration over time.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of oral drug treatments for low back pain? What are the effects of local injections for low back pain? What are the effects of non-drug treatments for low back pain? We searched: Medline, Embase, The Cochrane Library, and other important databases up to May 2007 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 34 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review we present information relating to the effectiveness and safety of the following interventions: acupuncture, advice to stay active, analgesics (paracetamol, opioids), back exercises, back schools, bed rest, behavioural therapy, electromyographic biofeedback, epidural corticosteroid injections, lumbar supports, massage, multidisciplinary treatment programmes, muscle relaxants, non-steroidal anti-inflammatory drugs (NSAIDs), spinal manipulation (in the short term), temperature treatments (short wave diathermy, ultrasound, ice, heat), traction, and transcutaneous electrical nerve stimulation (TENS).
Key Points
Low back pain is pain, muscle tension, or stiffness, localised below the costal margin and above the inferior gluteal folds, with or without referred or radicular leg pain (sciatica), and is defined as acute when pain persists for less than 12 weeks. Low back pain affects about 70% of people in resource-rich countries at some point.Acute low back pain is usually self-limiting, although 2-7% develop chronic pain. Acute low back pain has a high recurrence rate with less-painful symptoms recurring in 50-80% of people within a year; one year later, as high as 33% still experience moderate-intensity pain and 15% experience severe pain.
NSAIDs have been shown to effectively improve symptoms compared with placebo. However, their use is associated with gastrointestinal adverse effects. Muscle relaxants may also reduce pain and improve overall clinical assessment, but are associated with some severe adverse effects including drowsiness, dizziness, and nausea.The studies examining the effects of analgesics such as paracetamol or opioids were generally too small to detect any clinically important differences.
We found no studies examining the effectiveness of epidural injections of corticosteroids in treating people with acute low back pain.
With regard to non-drug treatments, advice to stay active (be it as a single treatment or in combination with other interventions such as back schools, a graded activity programme, or behavioural counselling) seems the most effective. Spinal manipulation (in the short term) also seems to reduce pain, but not functional outcomes, compared with sham treatments.We found insufficient evidence to judge the effectiveness of acupuncture, back schools, behavioural therapy, massage, multidisciplinary treatment programmes (for either acute or subacute low back pain), ortemperature treatments in treating people with acute low back pain.We found no evidence examining the effectiveness of electromyographic biofeedback, lumbar supports, traction, or TENS in the treatment of acute low back pain. Back exercises do not seem to increase recovery time compared with no treatment, although there is considerable heterogeneity among studies with regard to the definition of back exercise. There is also disparity among studies in the definition of generic and specific back exercise. Bed rest does not improve symptoms any more effectively than other treatments, but does produce a number of adverse effects including joint stiffness, muscle wasting, loss of bone mineral density, pressure sores, and venous thromboembolism.
PMCID: PMC2907975  PMID: 19445792
16.  Endoscopically Guided Foraminal and Dorsal Rhizotomy for Chronic Axial Back Pain Based on Cadaver and Endoscopically Visualized Anatomic Study 
Background
Conventional fluoroscopically guided continuous radiofrequency (CRF) and pulsed Radiofrequency (PRF) lesioning of the medial branch, dorsal ramus, a standard technique to treat facet pain, is compared to an endoscopic visually guided technique. The endoscopic technique (Figure 1) is designed to ablate a larger area of the transverse process where the medial branch crosses to innervate the facet. Endoscopically guided visualization provides confirmation of nerve ablation or transection in the most common location of the branches of the dorsal ramus innervating the facet joint.
Surgical setup for ablation of the medial, intermediate and lateral branches of the dorsal ramus.
Materials and Method
A retrospective non randomized study of 50 initial patients assessed the efficacy of endoscopic rhizotomy. Patients with lumbar spondylosis and facet arthrosis who had at least 50% pain relief by medial branch blocks met the inclusion criteria for the visualized, surgically directed endoscopic technique. A specially designed cannula and endoscope (Richard Wolf, GmBh) (Figure 2) was developed specifically for this purpose. After completion of the initial 50 patient pilot study in 2005, utilizing a low-temperature, ultra-high frequency (1.7-4.0 MHz) bipolar energy radiofrequency source (Elliquence Int, Hewlett, NY) that demonstrated efficacy, 400 subsequent patients were added to this retrospective study by May 2013. The surgical technique refinement was guided by cadaveric variations observed from additional cadaver dissections (Figure 3) and endoscopic visualization of foraminal nerves that revealed variable locations of the dorsal ramus, including the medial branch. The anatomic variations supported a need for visualized rhizotomy. The inclusion criteria also involved increasing the percentage of back pain relief from medial branch blocks to a base of 75% estimated improvement in order to overcome the variable subjectiveness of a 50% improvement threshold that served to disappoint a small percentage of patients who overestimated the reported 50% improvement in hopes that they would qualify for the endoscopic guided procedure.
Richard Wolf YESS Rhizotomy Set. The cannulas, endoscope, bitip and surgical bipolar RF probes by Elliquence are configured ergonomically to provide excellent focal length imaging to keep image in focus with the endoscope scope resting on cannula. The bitip probe cuts tissue, and the RF probe thermally ablates tissue efficiently.
Cadaver dissection of the dorsal ramus and its branches out- lining the areas where branches of the dorsal ramus may be visualized and ablated before it reaches the facet joint.
Results
At one year follow-up in the initial study design, VAS improved 6.2-2.5, and ODI 48-28. All patients had VAS improvement equal or greater than injection. The results remained constant with additional surgical cases that continued to improve when technique and visualized rhizotomy allowed for greater surgical exploration and ablation of the targeted zone where more than just the medial branch could be ablated. Approximately 10 percent of the patients returned at one and two year follow-up with mild recurrence of their axial back pain, but none to the original level of pain. Additional rhizotomy of the upper lumbar facets provided additional relief in selected patients.
Conclusions / level of evidence 3
The cadaver studies demonstrated considerable variability in the location of the medial and lateral branches of the dorsal ramus. Variability was most common cephalad to L3-4. The dorsal ramus and its nerve branches can also be visualized in the foramen ventral to the intertransverse ligament. Neuromas and entrapment of the dorsal ramus has been identified endoscopically, and confirmed by H and E slides (Figure 4). In the upper lumbar spine, we were not able to find the medial branch to the facets consistently at same location. The nerve to the facet joint did not always cross the transverse process. Some branches enter the facet joint before crossing the transverse process adjacent to the tip of the SAP (Figure 5). The nerve can be mistaken for a furcal nerve or foraminal ligament. Nerve Ablation at above L3-4 levels may require lesioning of the dorsal ramus or targeting the nerve innervation on the facet wall, pedicle or capsule.
This H and E slide of the biopsied specimen is consistent with a peripheral nerve fiber.
This foraminal view of a branch of the dorsal ramus is in the foramen at the level of the SAP. The nerve runs along the ventral lateral aspect of the superior facet to the tip, and can also run in the vicinity of the foraminal ligament. Endoscopic rasps, trephines, kerrisons, and burrs can be used for foraminoplasty. The nerve should be preserved, if possible, but transection of a branch of the dorsal ramus contributes to axial back pain relief. Branches of the dorsal ramus originates in the foramen before exiting to traverse the transverse process. These nerves are difficult to differentiate from furcal nerves arising from the spinal nerves. Palpating the nerve using local anesthesia can sometimes demonstrate a pain response, but not always, depending on the level of sedation and anesthetic use.
Clinical Relevance
Endoscopically guided facet rhizotomy provides more consistent ablation of the medial and lateral branches of the lumbar dorsal ramus compared to radiographically guided pulsed radiofrequency. The variations in the location of facet innervation can explain the variability of clinical results in fluoroscopically guided RF lesioning. This observation dictates a need for visually guided MIS procedure for best results.
doi:10.14444/1023
PMCID: PMC4325504
Endoscopic; rhizotomy; visualization
17.  MIS Fusion of the SI Joint: Does Prior Lumbar Spinal Fusion Affect Patient Outcomes? 
Background:
Sacroiliac (SI) joint pain is a challenging condition to manage as it can mimic discogenic or radicular low back pain, and present as low back, hip, groin and/or buttock pain. Patients may present with a combination of lumbar spine and SI joint symptoms, further complicating the diagnosis and treatment algorithm [1-3]. SI joint pain after lumbar spinal fusion has been reported in the literature. Both clinical and biomechanical studies show the SI joint to be susceptible to increased motion and stress at the articular surface with up to 40-75% of patients developing significant SI joint degeneration after 5 years.
In a recent case series study of 50 patients who underwent minimally invasive SI joint arthrodesis, 50% had undergone previous lumbar spinal fusion and 18% had symptomatic lumbar spine pathology treated conservatively [4].
The purpose of this study is to determine if history of previous lumbar fusion or lumbar pathology affects patient outcomes after MIS SI joint fusion surgery.
Methods:
We report on 40 patients with 24 month follow up treated with MIS SI joint fusion using a series of triangular porous plasma coated titanium implants (iFuse, SI-Bone, Inc. San Jose, CA). Outcomes using a numerical rating scale (NRS) for pain were obtained at 3-, 6-, 12- and 24 month follow up intervals. Additionally, patient satisfaction was collected at the latest follow up interval. Patients were separated into 3 cohorts: 1) underwent prior lumbar spine fusion (PF), 2) no history of previous lumbar spine fusion (NF), 3) no history of previous lumbar spine fusion with symptomatic lumbar spine pathology treated conservatively (LP). A repeated measures analysis of variance (rANOVA) was used to determine if the change in NRS pain scores differed across timepoints and subgroups. A decrease in NRS by 2 points was deemed clinically significant [5].
Results:
Mean age was 54 (±13) years and varied slightly but not statistically between groups. All subgroups experienced a clinically and statistically significant reduction in pain at all time points (mean change >2 points, p<0.001). There was a statistically significant effect of cohort (p=0.045), with the NF cohort (no prior lumbar spinal fusion) having a somewhat greater decrease in pain (by approximately 1 point) compared to the other 2 groups (PF and LP).Patient reported satisfaction by cohort was: 89% (NF), 92% (PF) and 63% (LP).Overall satisfaction rate was 87%.
Discussion and Conclusion:
Patients with SI joint pain, regardless of prior lumbar spine fusion history, show significant improvement in pain after minimally invasive SI joint fusion. The presence of symptomatic lumbar spine pathology potentially confounds the treatment affect, as patients may not be able to discriminate between symptoms arising from the SI joint and the lumbar spine. These patients expressed a lower satisfaction with surgery. Patients without other confounding lumbar spine pathology and who have not undergone previous spine surgery tend to be younger and experience a greater reduction in pain.
doi:10.2174/1874325001307010163
PMCID: PMC3664440  PMID: 23730380
Sacroiliac (SI) joint; lumbar fusion; minimally invasive surgery; MIS arthrodesis.
18.  Transforaminal injection of corticosteroids for lumbar radiculopathy: systematic review and meta-analysis 
European Spine Journal  2011;21(2):214-219.
Background
Transforaminal epidural injection of steroids is used to treat lumbar radicular pain. However, there are only a few well-designed randomized, controlled studies on the effectiveness of steroid injection.
Study design
Hence, this study aims to assess the effectiveness of steroid injection to treat lumbar radicular pain using a meta-analysis of transforaminal epidural injection therapy for low back and lumbar radicular pain. The comparison was based on the mean difference in the Visual Analogue Score (VAS) and Oswestry Disability Index (ODI) from baseline to the specified followed up.
Methods
The available literature of lumbar transforaminal epidural injections in managing low back and radicular pain was reviewed. Data sources included relevant literature of the English language identified through searches of PubMed and EMBASE from 1966 to 2009, and manual searches of the bibliographies of known primary and review articles. Finally, the search included the Current Controlled Trials Register and the Cochrane Database of Controlled Trials.
Results
The initial search identified 126 papers. After screening, five randomised controlled trials (RCTs) were studied for analysis and only three of these had followed-up patients systematically with pain and disability outcome scores to 3 months and of these, only one had follow up to 12 months. A total of 187 patients (‘treatment group’ receiving local anaesthetic/steroid injection) were compared with 181 patients (‘control’ group, receiving local anaesthetic only or saline injection). Improvement in pain (standardised mean difference in VAS 0.2 in favour of ‘treatment’; 95%CI: −0.41 to 0.00, p = 0.05, I squared 0%) but not disability (standardised mean difference in ODI 0; 95%CI: −0.21 to 0.20, p = 0.99, I squared 0%) was observed between ‘treatment’ and ‘control’ groups; these differences were not significant. Additionally, the one study following patients to 12 months did not find any significant difference in VAS and ODI between treatment and control groups.
Conclusion
The current meta-analysis shows that transforaminal epidural steroid injections, when appropriately performed, should result in an improvement in pain, but not disability. The three RCTs that followed patients to 3 months (and the single study to 12 months) have found no benefit by the addition of steroids. The limitations of this study include the paucity of the available literature.
doi:10.1007/s00586-011-2008-y
PMCID: PMC3265602  PMID: 21892774
Transforaminal epidural steroids; Radiculopathy; Sciatica; Steroids; Local anaesthetic
19.  Acupuncture for low back pain due to spondylolisthesis: study protocol for a randomized controlled pilot trial 
Trials  2014;15:105.
Background
Spondylolisthesis is the major cause of refractory low back pain. There are many studies of the surgical treatment of spondylolisthesis, but few of conservative treatments. There is also no optimal conservative treatment protocol, however, low back pain caused by low-grade spondylolisthesis is controlled with non-surgical pain management. Acupuncture has become a useful method for treating low back pain, but there has not been any study of its efficacy in relation to spondylolisthesis. This study was designed to establish the feasibility of a randomized controlled trial and the safety of acupuncture for low back pain due to low-grade spondylolisthesis.
Methods/Design
The study is a randomized controlled pilot clinical trial of five weeks duration. Fourteen patients will be recruited and randomly allocated to two groups: an acupuncture plus interlaminar epidural steroid injection group (experimental group), and an interlaminar epidural steroid injection group (control group). All patients will be administered an interlaminar epidural steroid injection once a week for three weeks (three injections in total), but only the experimental group will receive additional treatment with three acupuncture sessions a week for three weeks (nine acupuncture sessions in total). The primary outcome will be measured by the visual analogue scale (VAS). Our primary end point is three-week VAS. The secondary outcome will be measured using the PainVision system, the short-form McGill Pain Questionnaire, and the Oswestry Disability Index. Assessments will be made at baseline and at one, three and five weeks thereafter (that is, the five-week assessment will be made two weeks after treatment cessation).
Discussion
This randomized controlled pilot trial will inform the design of a further full-scale trial. The outcomes will provide some resources for incorporating acupuncture into existing pain management methods such as interlaminar epidural steroid injection in low-grade spondylolisthesis.
Trial registration
This trial is registered with the US National Institutes of Health Clinical Trials registry: NCT01909284.
doi:10.1186/1745-6215-15-105
PMCID: PMC4006524  PMID: 24693959
Acupuncture; Interlaminar epidural steroid injection; Spondylolisthesis
20.  Discogenic Axial Back Pain: Is There a Role for Nucleoplasty? 
Asian Spine Journal  2013;7(4):314-321.
Study Design
A prospective observational study.
Purpose
To evaluate the role of nucleoplasty in the management of discogenic axial back pain; to determine the influence of concordant pain during provocative discography, annular tear and loss of disc height on the outcome of nucleoplasty.
Overview of Literature
The role of nucleoplasty in the management of radicular leg pain due to disc herniation is known. However, the data regarding its role in the management of discogenic axial back pain is scarce.
Methods
A prospective evaluation of 30 patients with discogenic axial back pain undergoing nucleoplasty was performed. Pain, functional disability and quality of life were assessed using the 100 mm visual analogue scale (VAS), Oswestry Disability Index (ODI) and Short Form-36 (SF-36), respectively.
Results
The mean reduction in VAS was 31.03 and 29.03; mean reduction in ODI was 24.53 and 20.60; and mean increment in SF-36 was 13.58 and 12.30, at 6 months and at 12 months, respectively. The differences were statistically significant (p <0.05). Concordant pain during provocative discography, annular tear and loss of disc height did not affect a clinically significant improvement in any of the three outcomes (p =0.882, 0.213, and 0.170; respectively).
Conclusions
Nucleoplasty produced statistically significant improvements in pain, functional disability and quality of life in patients with discogenic low back pain at 6 months and at 12 months. Concordant pain during provocative discography, annular tear and loss of disc height did not influence any of the outcomes after nucleoplasty in patients with discogenic axial back pain.
doi:10.4184/asj.2013.7.4.314
PMCID: PMC3863658  PMID: 24353849
Nucleoplasty; Radiofrequency treatment; Axial back pain; Degenerate disc disease
21.  Study Protocol- Lumbar Epidural Steroid Injections for Spinal Stenosis (LESS): a double-blind randomized controlled trial of epidural steroid injections for lumbar spinal stenosis among older adults 
Background
Lumbar spinal stenosis is one of the most common causes of low back pain among older adults and can cause significant disability. Despite its prevalence, treatment of spinal stenosis symptoms remains controversial. Epidural steroid injections are used with increasing frequency as a less invasive, potentially safer, and more cost-effective treatment than surgery. However, there is a lack of data to judge the effectiveness and safety of epidural steroid injections for spinal stenosis. We describe our prospective, double-blind, randomized controlled trial that tests the hypothesis that epidural injections with steroids plus local anesthetic are more effective than epidural injections of local anesthetic alone in improving pain and function among older adults with lumbar spinal stenosis.
Methods
We will recruit up to 400 patients with lumbar central canal spinal stenosis from at least 9 clinical sites over 2 years. Patients with spinal instability who require surgical fusion, a history of prior lumbar surgery, or prior epidural steroid injection within the past 6 months are excluded. Participants are randomly assigned to receive either ESI with local anesthetic or the control intervention (epidural injections with local anesthetic alone). Subjects receive up to 2 injections prior to the primary endpoint at 6 weeks, at which time they may choose to crossover to the other intervention.
Participants complete validated, standardized measures of pain, functional disability, and health-related quality of life at baseline and at 3 weeks, 6 weeks, and 3, 6, and 12 months after randomization. The primary outcomes are Roland-Morris Disability Questionnaire and a numerical rating scale measure of pain intensity at 6 weeks. In order to better understand their safety, we also measure cortisol, HbA1c, fasting blood glucose, weight, and blood pressure at baseline, and at 3 and 6 weeks post-injection. We also obtain data on resource utilization and costs to assess cost-effectiveness of epidural steroid injection.
Discussion
This study is the first multi-center, double-blind RCT to evaluate the effectiveness of epidural steroid injections in improving pain and function among older adults with lumbar spinal stenosis. The study will also yield data on the safety and cost-effectiveness of this procedure for older adults.
Trial Registration
Clinicaltrials.gov NCT01238536
doi:10.1186/1471-2474-13-48
PMCID: PMC3349603  PMID: 22458343
22.  The Role of Thoracic Medial Branch Blocks in Managing Chronic Mid and Upper Back Pain: A Randomized, Double-Blind, Active-Control Trial with a 2-Year Followup 
Study Design. A randomized, double-blind, active-control trial. Objective. To determine the clinical effectiveness of therapeutic thoracic facet joint nerve blocks with or without steroids in managing chronic mid back and upper back pain. Summary of Background Data. The prevalence of thoracic facet joint pain has been established as 34% to 42%. Multiple therapeutic techniques utilized in managing chronic thoracic pain of facet joint origin include medial branch blocks, radiofrequency neurotomy, and intraarticular injections. Methods. This randomized double-blind active controlled trial was performed in 100 patients with 50 patients in each group who received medial branch blocks with local anesthetic alone or local anesthetic and steroids. Outcome measures included the numeric rating scale (NRS), Oswestry Disability Index (ODI), opioid intake, and work status, at baseline, 3, 6, 12, 18, and 24 months. Results. Significant improvement with significant pain relief and functional status improvement of 50% or more were observed in 80% of the patients in Group I and 84% of the patients in Group II at 2-year followup. Conclusions. Therapeutic medial branch blocks of thoracic facets with or without steroids may provide a management option for chronic function-limiting thoracic pain of facet joint origin.
doi:10.1155/2012/585806
PMCID: PMC3407605  PMID: 22851967
23.  Low back pain (acute) 
Clinical Evidence  2011;2011:1102.
Introduction
Low back pain affects about 70% of people in resource-rich countries at some point in their lives. Acute low back pain can be self-limiting; however, 1 year after an initial episode, as many as 33% of people still have moderate-intensity pain and 15% have severe pain. Acute low back pain has a high recurrence rate; 75% of those with a first episode have a recurrence. Although acute episodes may resolve completely, they may increase in severity and duration over time.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of oral drug treatments for acute low back pain? What are the effects of local injections for acute low back pain? What are the effects of non-drug treatments for acute low back pain? We searched: Medline, Embase, The Cochrane Library, and other important databases up to December 2009 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 49 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review we present information relating to the effectiveness and safety of the following interventions: acupuncture, advice to stay active, analgesics (paracetamol, opioids), back exercises, back schools, bed rest, behavioural therapy, electromyographic biofeedback, epidural corticosteroid injections, lumbar supports, massage, multidisciplinary treatment programmes, muscle relaxants, non-steroidal anti-inflammatory drugs (NSAIDs), spinal manipulation, temperature treatments (short-wave diathermy, ultrasound, ice, heat), traction, and transcutaneous electrical nerve stimulation (TENS).
Key Points
Low back pain is pain, muscle tension, or stiffness, localised below the costal margin and above the inferior gluteal folds, with or without referred or radicular leg pain (sciatica), and is defined as acute when pain persists for <12 weeks. Low back pain affects about 70% of people in resource-rich countries at some point in their lives.Acute low back pain may be self-limiting, although there is a high recurrence rate with less-painful symptoms recurring in 50% to 80% of people within 1 year of the initial episode; 1 year later, as many as 33% of people still experience moderate-intensity pain and 15% experience severe pain.
NSAIDs have been shown to effectively improve symptoms compared with placebo. However, their use is associated with gastrointestinal adverse effects. Muscle relaxants may also reduce pain and improve overall clinical assessment, but are associated with some severe adverse effects including drowsiness, dizziness, and nausea.The studies examining the effects of analgesics such as paracetamol or opioids were generally too small to detect any clinically important differences.
We found no studies examining the effectiveness of epidural injections of corticosteroids in treating people with acute low back pain.
With regard to non-drug treatments, advice to stay active (be it as a single treatment or in combination with other interventions such as back schools, a graded activity programme, or behavioural counselling) may be effective. We don't know whether spinal manipulation improves pain or function compared with sham treatments.We found insufficient evidence to judge the effectiveness of acupuncture, back schools, behavioural therapy, massage, multidisciplinary treatment programmes (for either acute or subacute low back pain), lumbar supports, TENS, or temperature treatments in treating people with acute low back pain.We found no evidence examining the effectiveness of electromyographic biofeedback or traction in the treatment of acute low back pain. Back exercises may decrease recovery time compared with no treatment, but there is considerable heterogeneity among studies with regard to the definition of back exercise. There is a large disparity among studies in the definition of generic versus specific back exercise. Bed rest does not improve symptoms any more effectively than other treatments, but does produce a number of adverse effects including joint stiffness, muscle wasting, loss of bone mineral density, pressure sores, and venous thromboembolism.
PMCID: PMC3217769  PMID: 21549023
24.  Correlation between Epidurographic Contrast Flow Patterns and Clinical Effectiveness in Chronic Lumbar Discogenic Radicular Pain Treated with Epidural Steroid Injections Via Different Approaches 
The Korean Journal of Pain  2014;27(4):353-359.
Background
Epidural steroid injections are an accepted procedure for the conservative management of chronic backache caused by lumbar disc pathology. The purpose of this study was to evaluate the epidurographic findings for the midline, transforaminal and parasagittal approaches in lumbar epidural steroid injections, and correlating them with the clinical improvement.
Methods
Sixty chronic lower back pain patients with unilateral radiculitis from a herniated/degenerated disc were enrolled. After screening the patients according to the exclusion criteria and randomly allocating them to 3 groups of 20 patients, fluoroscopic contrast enhanced epidural steroids were injected via midline (group 1), transforaminal (group 2) and parasagittal interlaminar (group 3) approaches at the level of the pathology. The fluoroscopic patterns of the three groups were studied and correlated with the clinical improvement measured by the VAS over the next 3 months; any incidences of complications were recorded.
Results
The transforaminal group presented better results in terms of VAS reduction than the midline and parasagittal approach groups (P < 0.05). The epidurography showed a better ventral spread for both the transforaminal (P < 0.001) and the paramedian approaches (P < 0.05), as compared to the midline approach. The nerve root filling was greater in the transforaminal group (P < 0.001) than in the other two groups. The ventral spread of the contrast agent was associated with improvement in the VAS score and this difference was statistically significant in group 1 (P < 0.05), and highly significant in groups 2 and 3 (P < 0.001). In all the groups, any complications observed were transient and minor.
Conclusions
The midline and paramedian approaches are technically easier and statistically comparable, but clinically less efficacious than the transforaminal approach. The incidence of ventral spread and nerve root delineation show a definite correlation with clinical improvement. However, an longer follow-up period is advisable for a better evaluation of the actual outcom.
doi:10.3344/kjp.2014.27.4.353
PMCID: PMC4196501  PMID: 25317285
epidural steroid injection; fluoroscopy; midline interlaminar; parasagittal interlaminar; transforaminal
25.  A randomized, controlled trial of spinal endoscopic adhesiolysis in chronic refractory low back and lower extremity pain [ISRCTN 16558617] 
BMC Anesthesiology  2005;5:10.
Background
Postoperative epidural fibrosis may contribute to between 5% to 60% of the poor surgical outcomes following decompressive surgery. Correlations have been reported between epidural scarring and radicular pain, poor surgical outcomes, and a lack of any form of surgical treatment. The use of spinal endoscopic adhesiolysis in recent years in the management of chronic refractory low back and lower extremity pain has been described.
Methods
A prospective, randomized, double-blind trial was conducted to determine the outcome of spinal endoscopic adhesiolysis to reduce pain and improve function and psychological status in patients with chronic refractory low back and lower extremity pain. A total of 83 patients were evaluated, with 33 patients in Group I and 50 patients in Group II. Group I served as the control, with endoscopy into the sacral level without adhesiolysis, followed by injection of local anesthetic and steroid. Group II received spinal endoscopic adhesiolysis, followed by injection of local anesthetic and steroid.
Results
Among the 50 patients in the treatment group receiving spinal endoscopic adhesiolysis, significant improvement without adverse effects was shown in 80% at 3 months, 56% at 6 months, and 48% at 12 months. The control group showed improvement in 33% of the patients at one month and none thereafter. Based on the definition that less than 6 months of relief is considered short-term and longer than 6 months of relief is considered long-term, a significant number of patients obtained long-term relief with improvement in pain, functional status, and psychological status.
Conclusion
Spinal endoscopic adhesiolysis with targeted delivery of local anesthetic and steroid is an effective treatment in a significant number of patients with chronic low back and lower extremity pain without major adverse effects.
doi:10.1186/1471-2253-5-10
PMCID: PMC1187869  PMID: 16000173

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