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.
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.
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.
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.
chronic axial low back pain; discogenic pain; disc herniation; caudal 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.
Chronic neck pain; cervical disc herniation; upper extremity pain; cervical epidural injections; epidural steroids; local anesthetics
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.
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.
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.
Cervical interlaminar epidural injections of local anesthetic with or without steroids may be effective in patients with chronic function-limiting discogenic or axial pain.
chronic neck pain; cervical disc herniation; cervical discogenic pain; cervical epidural injections; epidural steroids; local anesthetics
To evaluate the efficacy of intradiscal methylene blue (MB) injection in patients with chronic discogenic low back pain.
Twenty patients with discogenic low back pain (4 males, 16 females; mean age 45.6 years) refractory to conservative management were recruited. All subjects underwent MB injection in target lumbar intervertebral discs confirmed by provocative discography. The clinical outcome was assessed by visual analog scale (VAS) and Oswestry disability index (ODI) at baseline and 1, 3, 6 and 12 months after treatment. Successful outcome was described as minimum of 2 points reduction in pain intensity compared with the baseline.
VAS and ODI significantly decreased after one injection. The average VAS and ODI were reduced significantly from 5.1 and 38.0 at baseline to 3.2 and 27.4 at 3 months after injection (p<0.05). However, the mean score of VAS at 12 month follow-up was 4.5 and we could not observe any difference between 12 months after injection and pretreatment. Eleven of twenty patients (55%) reported successful outcomes after intradiscal MB injection at 3 month follow up and the average VAS was reduced by 3.3±1.1 (p<0.05). At the time of 12 month follow up, pain had relapsed in 6 patients who have had satisfactory effect at 3 month follow up. Successful outcome was maintained in only 5 patients (20%) for 1 year.
The intradiscal MB injection is a short-term effective minimally invasive treatment indicated for discogenic back pain but it may lose its effectiveness long-term.
Intradiscal methylene blue injection; Discogenic low back pain
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.
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
We present here a rare case of heterotopic ossification in interspinous/interlaminar Coflex device. The classical surgical indications for these implants are degenerative canal stenosis, discogenic low back pain, disk herniations, facet syndrome, and instability. However, fractures of spinous processes are a potential risk after interspinous/interlaminar devices' implantation. Recently, heterotopic ossification, a well-known complication of hip and knee arthroplasty, has been reported after cervical and lumbar prosthesis. We performed undercutting and implantation of the dynamic interspinous/interlaminar device to treat an adult male patient with L4-L5 stenosis. The patient underwent 45-day imaging and clinical followup, and we observed both a neurological and imaging improvement. A CT bone scan, performed 3 years after surgery for recurrence of neurogenic claudication, showed a new stenosis due to an abnormal ossification all over the device. To our knowledge, this is the first reported case of heterotopic ossification in an interspinous/interlaminar dynamic device. Accordingly, we aim to suggest it as a new complication of interspinous/interlaminar devices.
Study Design: Prospective observational study.
Objective: Our aim is to investigate the efficacy and safety of TransDiscal Biacuplasty.
Summary of Background Data: Chronic discogenic pain is one of the leading causes of low back pain; however, the condition is not helped by most non-invasive methods. The results of major surgical operations for these patients are unsatisfactory. Recently, attention has shifted to disk heating methods for treatment. TransDiscal Biacuplasty is one of the minimally invasive treatment methods. The method was developed as an alternative to spinal surgical practices and Intradiscal Electrothermal Therapy for treatment of patients with chronic discogenic pain.
Methods: The candidates for this study were patients with chronic discogenic pain that did not respond to conservative treatment. The main criteria for inclusion were: the existence of axial low back pain present for 6 months; disc degeneration or internal disc disruption at a minimum of one level, and maximum of two levels, in MR imaging; and positive discography. Physical function was assessed using the Oswestry Disability Index when measuring the pain with VAS. Patient satisfaction was evaluated using a 4-grade scale. Follow-ups were made 1, 3, and 6 months after treatment.
Results: 15 patients were treated at one or two levels. The mean patient age was 43.1±9.2 years. We found the mean symptom duration to be 40.5±45.7 months. At the sixth month, 57.1% of patients reported a 50% or more reduction in pain, while 78.6% of patients reported a reduction of at least two points in their VAS values. In the final check, 78.6% of patients reported a 10-point improvement in their Oswestry Disability scores compared to the initial values. No complications were observed in any of the patients.
Conclusions: TransDiscal Biacuplasty is an effective and safe method.
discogenic pain; low back pain; transdiscal biacuplasty; intradiscal electrothermal therapy; cool radiofrequency
Because previous studies have suggested that motorized non-surgical spinal decompression can reduce chronic low back pain (LBP) due to disc degeneration (discogenic low back pain) and disc herniation, it has accordingly been hypothesized that the reduction of pressure on affected discs will facilitate their regeneration. The goal of this study was to determine if changes in LBP, as measured on a verbal rating scale, before and after a 6-week treatment period with non-surgical spinal decompression, correlate with changes in lumbar disc height, as measured on computed tomography (CT) scans.
A retrospective cohort study of adults with chronic LBP attributed to disc herniation and/or discogenic LBP who underwent a 6-week treatment protocol of motorized non-surgical spinal decompression via the DRX9000 with CT scans before and after treatment. The main outcomes were changes in pain as measured on a verbal rating scale from 0 to 10 during a flexion-extension range of motion evaluation and changes in disc height as measured on CT scans. Paired t-test or linear regression was used as appropriate with p < 0.05 considered to be statistically significant.
We identified 30 patients with lumbar disc herniation with an average age of 65 years, body mass index of 29 kg/m2, 21 females and 9 males, and an average duration of LBP of 12.5 weeks. During treatment, low back pain decreased from 6.2 (SD 2.2) to 1.6 (2.3, p < 0.001) and disc height increased from 7.5 (1.7) mm to 8.8 (1.7) mm (p < 0.001). Increase in disc height and reduction in pain were significantly correlated (r = 0.36, p = 0.044).
Non-surgical spinal decompression was associated with a reduction in pain and an increase in disc height. The correlation of these variables suggests that pain reduction may be mediated, at least in part, through a restoration of disc height. A randomized controlled trial is needed to confirm these promising results.
Clinical trial registration number
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.
Discogenic pain; Acute low-back pain; Acute nonspecific low-back pain
Chronic low back pain can be a manifestation of lumbar degenerative disease, herniation of intervertebral discs, arthritis, or lumbar stenosis. When nerve roots are compromised, low back pain, with or without lower extremity involvement, may occur. Local inflammatory processes play an important role in patients with acute lumbosciatic pain. The purpose of this study was to assess the value of erythrocyte sedimentation rate (ESR) and high sensitivity C-reactive protein (hsCRP) measurements in patients with chronic low back pain or radiculopathy.
ESR and hsCRP were measured in 273 blood samples from male and female subjects with low back pain and/or radiculopathy due to herniated lumbar disc, spinal stenosis, facet syndrome, and other diseases. The hsCRP and ESR were measured prior to lumbar epidural steroid injection.
The mean ESR was 18.8 mm/h and mean hsCRP was 1.1 mg/L. ESR had a correlation with age.
A significant systemic inflammatory reaction did not appear to arise in patients with chronic low back pain.
ESR; hsCRP; low back pain
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.
Chronic low back pain; post lumbar surgery syndrome; recurrent disc herniation; epidural fibrosis; spinal stenosis; caudal epidural steroid injections.
The purpose of this study is to investigate if lumbar disc pathology identified on MRI scans is more common in patients with acute, likely discogenic, low back pain than matched controls.
We compared rates of MRI findings between 30 cases with low back pain and 30 pain-free controls. Cases were patients presenting for care with likely discogenic low back pain (demonstrated centralisation with repeated movement testing), of moderate intensity and with minimal past history of back pain. Controls were matched for age, gender and past history of back pain. Cases and controls underwent MRI scanning which was read for the presence of a range of MRI findings by two blinded assessors.
The presence of disc degeneration, modic changes and disc herniation significantly altered the odds of a participant being a case or control. For example subjects were 5.2 times more likely to be a case than a control when disc degeneration grade of ≥3 was present, and 6.0 times more likely with modic changes. The presence of a high-intensity zone or annular tear was found to significantly alter odds for one assessor but not the other assessor.
MRI findings including disc degeneration, modic changes and herniation are more common in selected people with current acute (likely discogenic) low back pain than in controls without current low back pain. Further investigation of the value of MRI findings as prognostic factors and as treatment effect modifiers is required to assess the potential clinical importance of these findings.
Low back pain; Magnetic resonance imaging; Case–control study; Diagnosis; Sensitivity; Disc degeneration
Degeneration of lumbar intervertebral discs is thought to be a cause of low back pain. Studies have found that a cause of discogenic low back pain is intervertebral disc inflammation and axonal growth of afferent fibers innervating the disc. Lumbar spine fusion for chronic discogenic low back pain is considered an effective procedure. However, no study has investigated the mechanism of pain relief. We did this by applying Fluoro-Gold (FG) to the ventral aspect of the L4–L5 intervertebral discs of 40 rats. We exposed the nucleus pulposus to the annulus fibrosus in a disc punctured model. Rats were divided into 4 groups. Group A: Punctured intervertebral disc with sham posterolateral fusion (PLF) (n = 10), Group B: Punctured intervertebral disc with PLF (n = 15), Group C: Normal intervertebral disc (no puncture) with PLF (n = 10), and Group D: Normal disc (no disc puncture) with sham PLF (n = 5). Four weeks after surgery, bilateral L1–L5 dorsal root ganglia (DRGs) were stained with growth-associated protein 43 (GAP43), a marker of axonal growth, and calcitonin gene-related peptide (CGRP), a neuropeptide marker of pain. Bone union was evaluated using X-ray imaging. Of the FG-labeled neurons, the proportions of GAP43- and CGRP-immunoreactive (IR) neurons in Group A were significantly higher than in Group D (P < 0.05). The proportions of GAP43- and CGRP-IR neurons in bone union rats in Group B were significantly lower than in nonunion rats in Group B and in the rats in Group A (P < 0.05). No significant differences in GAP43- and CGRP-IR neurons were observed between bone union and nonunion rats in Group C and the rats in Group D (P > 0.05). PLF is strongly related to the downregulation of GAP43 and CGRP expression. Therefore, PLF may suppress the increase of inflammatory neuropeptides and the process of axonal growth. Moreover, these results may explain, in part, the mechanism of pain relief following lumbar spinal fusion for chronic discogenic low back pain in humans.
Low back pain; Posterolateral fusion; Intervertebral disc; Immunohistochemistry; Nerve ingrowth
Low back pain (LBP) has become a main cause of absenteeism and disability in industrialized societies. Chronic LBP is an important health issue in modern countries. Discogenic LBP is one of the causes of chronic low back pain. The management of chronic discogenic LBP has been limited to either conservative treatment or operative treatment. Intradiscal electrothermal therapy (IDET) is now being performed as an alternative treatment.
Ninety-three consecutive patients undergoing IDET at 134 disc levels from October 2004 to January 2007 were prospectively evaluated. All patients had discogenic disease with chronic LBP, as determined by clinical features, physical examination and image studies, and had failed to improve with conservative treatment for at least 6 months. Follow-up period was from 1 week to 3 or more years postoperatively.
There were 50 male and 43 female patients, with a mean age of 46.07 years (range, 21-65 years). The results were classified as symptom free (100% improvement), better (≥50% improvement), slightly better (<50% improvement), unchanged and aggravated. Eighty-nine patients were followed up in the first week; of them, 77 (86.52%) patients had improvement (4, symptom free; 45, better; and 28, slightly better). The improvement rate gradually decreased to 80.90% in 1 year; and 73.91%, in 3 years.
In conclusion, IDET offers a safe, minimally invasive therapy option for carefully selected patients with chronic discogenic LBP who have not responded to conservative treatment. Although IDET appears to provide intermediate-term relief of pain, further studies with long-term follow-up are necessary.
Chronic low back pain; intradiscal electrothermal therapy; discogenic pain
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.
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.
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.
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.
epidural adhesions; epidural steroid injections; epidural fibrosis
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.
Discogenic low back pain; Discography; Methylene blue; Injection
Discogenic pain is a leading cause of chronic low back pain. The authors investigated the efficacy of pressure-controlled discography to determine its role in clinical decision-making for the management of patients with discogenic pain. Pressure-controlled discography was performed in 21 patients (51 discs) with pain-provocation, followed by post-discography computerized tomography scans. Pain response was classified as positive response and negative response, and measured with visual analog scale scores. Discographic findings were graded by the modified Dallas discogram scale. Elastance, pain provocation on intradiscal pressure, pressure and volume of initial pain response, and pain response intensity were statistically analyzed. Elastance showed significant differences between Grade 0 and Grade 4 & 5. Decreased elastance with positive pain response group was a good indicator to imply that disc degeneration presumably is a pain generator. Results of pain response were well correlated with intradiscal pressure but not with the amount of injected volume. Among 31 discs of Grade 4 and 5, 74% showed negative pain response and 26% showed positive response. It was concluded that pressure-controlled discography was useful to diagnose discogenic pain and excellent guide in decision-making for spinal operations.
Low Back Pain; Intervertebral Disk; Injections, Spinal
Low back pain (LBP) poses a significant problem to society. Although initial conservative therapy may be beneficial, persisting chronic LBP still frequently leads to expensive invasive intervention. A novel non-invasive therapy that focuses on discogenic LBP is Intervertebral Differential Dynamics Therapy® (IDD Therapy, North American Medical Corp. Reg U.S.). IDD Therapy consists of intermittent traction sessions in the Accu-SPINA device (Steadfast Corporation Ltd, Essex, UK), an FDA approved, class II medical device. The intervertebral disc and facet joints are unloaded through axial distraction, positioning and relaxation cycles. The purpose of this study is to investigate the effect of IDD Therapy when added to a standard graded activity program for chronic LBP patients. In a single blind, single centre, randomized controlled trial; 60 consecutive patients were assigned to either the SHAM or the IDD Therapy. All subjects received the standard conservative therapeutic care (graded activity) and 20 sessions in the Accu-SPINA device. The traction weight in the IDD Therapy was systematically increased until 50% of a person’s body weight plus 4.45 kg (10 lb) was reached. The SHAM group received a non-therapeutic traction weight of 4.45 kg in all sessions. The main outcome was assessed using a 100-mm visual analogue scale (VAS) for LBP. Secondary outcomes were VAS scores for leg pain, Oswestry Disability Index (ODI), Short-Form 36 (SF-36). All parameters were measured before and 2, 6 and 14 weeks after start of the treatment. Fear of (re)injury due to movement or activities (Tampa Scale for Kinesiophobia), coping strategies (Utrecht Coping List) and use of pain medication were recorded before and at 14 weeks. A repeated measures analysis was performed. The two groups were comparable at baseline in terms of demographic, clinical and psychological characteristics, indicating that the random allocation had succeeded. VAS low back pain improved significantly from 61 (±25) to 32 (±27) with the IDD protocol and 53 (±26) to 36 (±27) in the SHAM protocol. Moreover, leg pain, ODI and SF-36 scores improved significantly but in both groups. The use of pain medication decreased significantly, whereas scores for kinesiophobia and coping remained at the same non-pathological level. None of the parameters showed a difference between both protocols. Both treatment regimes had a significant beneficial effect on LBP, leg pain, functional status and quality of life after 14 weeks. The added axial, intermittent, mechanical traction of IDD Therapy to a standard graded activity program has been shown not to be effective.
Low back pain; Traction; IDD therapy®; Non-invasive therapy; Randomized clinical trial
Study design: Retrospective cohort study.
Objectives: To find out (1) if magnetic resonance imaging (MRI) findings associated with positive discography in patients with lumbar discogenic pain are caused by degenerative disc disease (DDD). (2) If clinical risk factors associated with positive discography in patients with lumbar discogenic pain are caused by DDD.
Methods: Thirty-three discographies were performed in 20 consecutive patients with chronic low back pain (LBP). All examinations were performed in the lumbar spine between L3 and S1. Patient assessment consisted of a clinical and radiological examination through a protocol that contained data on the history, visual analogue scale for pain (VAS), functional questionnaire (Oswestry), and MRI findings. Discography was considered positive using the Walsh's criteria. We examined the association between MRI and clinical findings with positive discography using logistic regression.
Results: Fourteen discographies (42%) were positive and 19 (58%) were negative. The mean age of patients with positive discography was 40.7 years (range, 25–56 years) and negative discography 43.1 years (range, 30–55 years). Men had a positive discography rate of 43.5% and women 40%. Patients with LBP had reduced odds of a positive discography compared with those with LBP and sciatica (OR = .5; 95% CI: 0.1–2.7); however, this association was not statistically significant. Patients with more than four previous episodes of pain versus patients with one to four episodes had greater odds of a positive discography (OR = 3.8; 95% CI: 0.07–184); but this association was not statistically significant. Patients with various pathologies on MRI had greater odds of a positive discography; however, these associations were not statistically significant either.
Conclusions: Patients with a chief complaint of LBP associated with sciatica, with more than four episodes of previous LBP exacerbations and the presence of a high intensity zone (HIZ) on MRI have a higher rate of positive discography. These findings are not statistically significant, probably due to a small sample size. During discography, we found the end point resistance to be more prevalent in asymptomatic discs.
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.
Central spinal stenosis; percutaneous adhesiolysis; steroids; local anesthetics; hypertonic sodium chloride solution
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.
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.
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.
Epidural steroid injections are an important therapeutic modality employed by spinal surgeons in the treatment of patients with chronic low back pain with or without lumbar radiculopathy. The caudal epidural is a commonly used and well-established technique; however, little is known about the segmental level of pathology that may be addressed by this intervention. This prospective study of over 50 patients aimed to examine the spreading pattern of this technique using epidurography. The effect of variation in Trendelenburg tilt and the eradication of lumbar lordosis on the cephalic distribution of the injectate were investigated. 52 patients with low back pain and radiculopathy underwent caudal epidural. All had 20 ml volume injected, comprised of 5 ml contrast (Ultravist™ Schering) 2 ml Triamcinolone (Adcortyl™ Squibb) and 13 ml local anaesthetic (1% lignocaine). Patients were randomised to either 0° or 30° of Trendelenburg tilt, as referenced from the lumbar spine. Patients were further randomised to presence or absence of lumbar lordosis, which was eradicated using a flexion device placed beneath the prone patient. A lateral image of each sacrum was obtained, to identify variations in sacral geometry particularly resistant to cephalic spread of injectate. The highest segment reached on fluoroscopy was recorded post injection. Fifty-two patients with a mean age of 50 years underwent caudal epidural. Thirty-one were in 0° head tilt, with 21 in 30° of head tilt. In each of these groups, 50% had their lumbar lordosis flattened prior to caudal injection. The median segmental level reached was L3, with a range from T9 to L5. Eradication of lumbar lordosis did not significantly alter cephalic spread of injectate. There was a trend for 30° tilt to extend the upper level reached by caudal injection (p = 0.08). There were no adverse events in this series. Caudal epidural is a reliable and relatively safe procedure for the treatment of low back pain. Pathology at L3/4 and L4/5 and L5/S1 can be approached by this technique. Although in selected cases thoracic and high lumbar levels can be reached, this is variable. If pathology at levels above L3 needs to be addressed, we propose a 30° head tilt may improve cephalic drug delivery. The caudal route is best reserved for pathology below L3.
Caudal epidural; Lumbar spine
Degenerative lumbar scoliosis is a coronal deviation of the spine that is prevalent in the elderly population. Although the etiology is unclear, it is associated with progressive and asymmetric degeneration of the disc, facet joints, and other structural spinal elements typically leading to neural element compression. Clinical presentation varies and is frequently associated with axial back pain and neurogenic claudication. Indications for treatment include pain, neurogenic symptoms, and progressive cosmetic deformity. Non-operative treatment includes physical conditioning and exercise, pharmacological agents for pain control, and use of orthotics and invasive modalities like epidural and facet injections. Operative treatment should be contemplated after multi-factorial and multidisciplinary evaluation of the risks and the benefits. Options include decompression, instrumented stabilization with posterior or anterior fusion, correction of deformity, or a combination of these that are tailored to each patient. Incidence of perioperative complications is substantial and must be considered when deciding appropriate operative treatment. The primary goal of surgical treatment is to provide pain relief and to improve the quality of life with minimum risk of complications.
degenerative scoliosis; adult scoliosis; adult deformity; spinal stenosis; secondary scoliosis
To investigate the efficacy and safety of percutaneous intradiscal monopolar pulsed radiofrequency (PRF) in patients with chronic disabling discogenic back pain.
Twenty-six subjects (7 males; mean age 43.2 years) with chronic back pain refractory to active rehabilitative management were recruited. All subjects underwent MRI for evaluation of Modic changes, and monopolar PRF (20 min at 60 V) at the center of target lumbar intervertebral disc confirmed by pressure-controlled provocative discography. Clinical outcomes were measured by the visual analogue scale (VAS), Oswestry disability index (ODI), and sitting tolerance time (ST) for 12 months after treatment. Successful clinical outcome was described as a minimum of 2 point reduction in VAS compared with the baseline at each follow-up period.
The mean VAS for low back pain reduced significantly from 6.4±1.1 at pre-treatment to 4.4±1.9 at 12 months (p<0.05). The mean ODI score was 47.3±15.4 points at pre-treatment and 36.7±19.5 at 12 months (p<0.001). The ST was 27.8±20.4 minutes at pre-treatment and 71.5±42.2 at 12 months (p<0.001). However, successful clinical outcome was achieved at 58%, 50%, and 42%, measured at 3, 6, and 12 months post-treatment. There were no significant relationship between the clinical outcome and Modic changes; no adverse events were recorded.
The results demonstrated that the application of intradiscal monopolar PRF might be relatively effective but limited; successful intervention for chronic refractory discogenic back pain is needed. To achieve the optimal outcome through intradiscal PRF, we suggested further studies about stimulation duration, mode, and intensity of PRF.
Pulsed radiofrequency; Discogenic pain; Intradiscal procedure
Degenerative disc disease (DDD) causes gradual intervertebral space collapse, concurrent discogenic or facet-induced pain, and possible compression radiculopathy. A new minimal invasion procedure of percutaneous posterior-lateral lumbar interbody fusion (PPLIF) using a B-Twin stand-alone expandable spinal spacer (ESS) was designed to treat this disease and evaluated by follow-up more than 1 year. 12 cases with chronic low back pain and compressive radiculopathy due to DDD refractory were selected to conservative treatment. Under fluoroscopy in the posterior-lateral position, a K-wire was advanced into the intervertebral space and a dilator and working cannula were introduced into the disc space step by step. Discectomy and endplate scratching were performed through the cannula using pituitary forceps and endplate curettage. An ESS was inserted into the intervertebral space by a B-Twin expandable spinal delivery system after some bone graft chips implanted into the disc space. The ongoing study includes intraoperative difficulties, complications, radiologic evidence of fusion and clinical outcome as scored by pre- and postoperative questionnaires pertaining to pain intensity and degree of disability. The 12 procedures of lumbar interbody fusion using stand-alone expandable spinal system through percutaneous approach were successful. Radiologic study demonstrated fusion in a total of 11 cases and only 1 exception after more than 1 year visiting. The values of Visual Analog Scale (VAS) on movement and Oswestry Disability Index (ODI) dropped by more than 80 and 67.4%, respectively. Disk space heights averaging 9.0 mm before procedure were increased to 11.5 mm 1 month (a significant difference compared with preprocedure, P < 0.01) after surgery and stabilized at 10.8 mm upon final follow-up (a significant difference compared with preprocedure, P < 0.01). The results demonstrated that the percutaneous approach for posterior-lateral lumbar interbody fusion using expandable spinal system is a valuable micro-invasion method for the DDD patients and can achieve the same outcome as with other methods.
Disk degenerative disease; Percutaneous; Lumbar interbody spinal fusion; Expandable spinal spacer; Stand-alone; B-Twin