Objective

The aim of this study was to evaluate the reporting of relevant prognostic information in a sample of randomized controlled trials (RCTs) that investigated treatments for patients with chronic low back pain (LBP). We also analysed how researchers conducting the meta-analyses and systematic reviews addressed the reporting of relevant prognostic information in RCTs.

Methods

We searched the Cochrane Database to identify systematic reviews that investigated non-surgical treatments for patients with chronic LBP. The reported prognostic information was then extracted from the RCTs included in the reviews. We used a purpose-defined score to assess the quantity of information reported in the RCTs. We also determined how the authors of systematic reviews addressed the question of comparability of patient populations between RCTs.

Results

Six systematic reviews met our inclusion criteria, and we analysed 84 RCTs. Based on the scores, the reporting of important prognostic variables was incomplete in almost half of the 84 RCTs. Information regarding patients’ general health, social support, and work-related conditions was rarely reported. Almost half of the studies included in one of the meta-analyses provided insufficient information that did not allow us to determine whether patients in the primary trials were comparable.

Conclusions

Missing prognostic information potentially threatens the external validity (i.e. the generalizability or applicability) not only of primary studies but also of systematic reviews that investigate treatments for LBP. A detailed description of baseline patient characteristics that includes prognostic information is needed in all RCTs to ensure that clinicians can determine the applicability of the study or review results to their patients.

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.

Introduction

Nurse understaffing is frequently hypothesized as a potential risk factor for healthcare-associated infections (HAI). This study aimed to evaluate the role of nursing workload in the occurrence of HAI, using Nursing Activities Score (NAS).

Methods

This prospective cohort study enrolled all patients admitted to 3 Medical ICUs and one step-down unit during 3 months (2009). Patients were followed-up until HAI, discharge or death. Information was obtained from direct daily observation of medical and nursing rounds, chart review and monitoring of laboratory system. Nursing workload was determined using NAS. Non-compliance to the nurses’ patient care plans (NPC) was identified. Demographic data, clinical severity, invasive procedures, hospital interventions, and the occurrence of other adverse events were also recorded. Patients who developed HAI were compared with those who did not.

Results

195 patients were included and 43 (22%) developed HAI: 16 pneumonia, 12 urinary-tract, 8 bloodstream, 2 surgical site, 2 other respiratory infections and 3 other. Average NAS and average proportion of non compliance with NPC were significantly higher in HAI patients. They were also more likely to suffer other adverse events. Only excessive nursing workload (OR: 11.41; p: 0.019) and severity of patient’s clinical condition (OR: 1.13; p: 0.015) remained as risk factors to HAI.

Conclusions

Excessive nursing workload was the main risk factor for HAI, when evaluated together with other invasive devices except mechanical ventilation. To our knowledge, this study is the first to evaluate prospectively the nursing workload as a potential risk factor for HAI, using NAS.

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.

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.

Use of multiple prescribers and pharmacies is a means by which some individuals misuse opioids. Community characteristics may be important determinants of the likelihood of this phenomenon independent of individual-level factors. This was a retrospective cohort study with individual-level data derived from California's statewide prescription drug monitoring program (PDMP) and county-level socioeconomic status (SES) data derived from the United States Census. Zero-truncated negative binomial (ZTNB) regression was used to model the association of individual factors (age, gender, drug schedule and drug dose type) and county SES factors (ethnicity, adult educational attainment, median household income, and physician availability) with the number of prescribers and the number of pharmacies that an individual used during a single year (2006). The incidence rates of new prescriber use and new pharmacy use for opioid prescriptions declined across increasing age groups. Males had a lower incidence rate of new prescriber use and new pharmacy use than females. The total number of licensed physicians and surgeons in a county was positively, linearly, and independently associated with the number of prescribers and pharmacies that individuals used for prescription opioids. In summary, younger age, female gender, and living in counties with more licensed physicians and surgeons were associated with use of more prescribers and/or more pharmacies for obtaining prescription opioids.

Background

Surgical Site Infections (SSI) are relatively frequent complications after colorectal surgery and are associated with substantial morbidity and mortality.

Objective

Implementing a bundle of care and measuring the effects on the SSI rate.

Design

Prospective quasi experimental cohort study.

Methods

A prospective surveillance for SSI after colorectal surgery was performed in the Amphia Hospital, Breda, from January 1, 2008 until January 1, 2012. As part of a National patient safety initiative, a bundle of care consisting of 4 elements covering the surgical process was introduced in 2009. The elements of the bundle were perioperative antibiotic prophylaxis, hair removal before surgery, perioperative normothermia and discipline in the operating room. Bundle compliance was measured every 3 months in a random sample of surgical procedures.

Results

Bundle compliance improved significantly from an average of 10% in 2009 to 60% in 2011. 1537 colorectal procedures were performed during the study period and 300 SSI (19.5%) occurred. SSI were associated with a prolonged length of stay (mean additional length of stay 18 days) and a significantly higher 6 months mortality (Adjusted OR: 2.71, 95% confidence interval 1.76–4.18). Logistic regression showed a significant decrease of the SSI rate that paralleled the introduction of the bundle. The adjusted Odds ratio of the SSI rate was 36% lower in 2011 compared to 2008.

Conclusion

The implementation of the bundle was associated with improved compliance over time and a 36% reduction of the SSI rate after adjustment for confounders. This makes the bundle an important tool to improve patient safety.

Among the multiple causes of chronic low back pain, axial and discogenic pain are common. Various modalities of treatments are utilized in managing discogenic and axial low back pain including epidural injections. However, there is a paucity of evidence regarding the effectiveness, indications, and medical necessity of any treatment modality utilized for managing axial or discogenic pain, including epidural injections. In an interventional pain management practice in the US, a randomized, double-blind, active control trial was conducted. The objective was to assess the effectiveness of lumbar interlaminar epidural injections of local anesthetic with or without steroids for managing chronic low back pain of discogenic origin. However, disc herniation, radiculitis, facet joint pain, or sacroiliac joint pain were excluded. Two groups of patients were studied, with 60 patients in each group receiving either local anesthetic only or local anesthetic mixed with non-particulate betamethasone. Primary outcome measures included the pain relief-assessed by numeric rating scale of pain and functional status assessed by the, Oswestry Disability Index, Secondary outcome measurements included employment status, and opioid intake. Significant improvement or success was defined as at least a 50% decrease in pain and disability. Significant improvement was seen in 77% of the patients in Group I and 67% of the patients in Group II. In the successful groups (those with at least 3 weeks of relief with the first two procedures), the improvement was 84% in Group I and 71% in Group II. For those with chronic function-limiting low back pain refractory to conservative management, it is concluded that lumbar interlaminar epidural injections of local anesthetic with or without steroids may be an effective modality for managing chronic axial or discogenic pain. This treatment appears to be effective for those who have had facet joints as well as sacroiliac joints eliminated as the pain source.

Purpose

To evaluate changes in nucleus pulposus volume as a potential parameter for the effects of disc decompression.

Methods

Fifty-two discs (T8 to L1) were extracted from 26 pigs and separated into thoracic (T8 to T11) and thoracolumbar discs (T12 to L1). The discs were imaged using 7.1 Tesla ultrahigh-field magnetic resonance imaging (MRI) with acquisition of axial T2-weighted turbo spin-echo sequences for determination of baseline and postinterventional nucleus pulposus volumes. Volumes were calculated using OsiriX® (http://www.osirix-viewer.com). After randomization, one group was treated with nucleoplasty, while the placebo group was treated with an identical procedure but without coblation current. The readers analyzing the MR images were blinded to the kind of procedure performed. Baseline and postinterventional volumes were compared between the nucleoplasty and placebo group.

Results

Average preinterventional nucleus volume was 0.799 (SD: 0.212) ml. Postinterventional volume reduction in the nucleoplasty group was significant at 0.052 (SD: 0.035) ml or 6.30% (p<0.0001) (thoracic discs) and 0.082 (SD: 0.042) ml or 7.25% (p = 0.0078) (thoracolumbar discs). Nucleoplasty achieved volume reductions of 0.114 (SD: 0.054) ml or 14.72% (thoracic) and 0.093 (SD: 0.081) ml or 11.61% (thoracolumbar) compared with the placebo group.

Conclusions

Nucleoplasty significantly reduces thoracic and thoracolumbar nucleus pulposus volumes in porcine discs.

Purpose

There are more drug overdose deaths in the Untied States than motor vehicle fatalities. Yet the US vital statistics reporting system is of limited value because the data are delayed by four years. Poison centers report data within an hour of the event, but previous studies suggested a small proportion of poisoning deaths are reported to poison centers (PC). In an era of improved electronic surveillance capabilities, exposure calls to PCs may be an alternate indicator of trends in overdose mortality.

Methods

We used PC call counts for methadone that were reported to the Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS®) System in 2006 and 2007. US death certificate data were used to identify deaths due to methadone. Linear regression was used to quantify the relationship of deaths and poison center calls.

Results

Compared to decedents, poison center callers tended to be younger, more often female, at home and less likely to require medical attention. A strong association was found with PC calls and methadone mortality (b = 0.88, se = 0.42, t = 9.5, df = 1, p<0.0001, R2 = 0.77). These findings were robust to large changes in a sensitivity analysis assessing the impact of underreporting of methadone overdose deaths.

Conclusions

Our results suggest that calls to poison centers for methadone are correlated with poisoning mortality as identified on death certificates. Calls received by poison centers may be used for timely surveillance of mortality due to methadone. In the midst of the prescription opioid overdose epidemic, electronic surveillance tools that report in real-time are powerful public health tools.

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.

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.

Background

Concern over rising healthcare expenditures has led to increased scrutiny of medical practices. As medical liability and malpractice risk rise to crisis levels, the medical-legal environment has contributed to the practice of defensive medicine as practitioners attempt to mitigate liability risk. High-risk specialties, such as neurosurgery, are particularly affected and neurosurgeons have altered their practices to lessen medical-legal risk. We present the first national survey of American neurosurgeons’ perceptions of malpractice liability and defensive medicine practices.

Methods

A validated, 51-question online-survey was sent to 3344 practicing U.S. neurosurgeon members of the American Association of Neurological Surgeons, which represents 76% of neurosurgeons in academic and private practices.

Results

A total of 1028 surveys were completed (31% response rate) by neurosurgeons representing diverse sub-specialty practices. Respondents engaged in defensive medicine practices by ordering additional imaging studies (72%), laboratory tests (67%), referring patients to consultants (66%), or prescribing medications (40%). Malpractice premiums were considered a “major or extreme” burden by 64% of respondents which resulted in 45% of respondents eliminating high-risk procedures from their practice due to liability concerns.

Conclusions

Concerns and perceptions about medical liability lead practitioners to practice defensive medicine. As a result, diagnostic testing, consultations and imaging studies are ordered to satisfy a perceived legal risk, resulting in higher healthcare expenditures. To minimize malpractice risk, some neurosurgeons have eliminated high-risk procedures. Left unchecked, concerns over medical liability will further defensive medicine practices, limit patient access to care, and increase the cost of healthcare delivery in the United States.

Background

At the end of the past century there were multiple concerns regarding lack of transparency in the conduct of clinical trials as well as some ethical and scientific issues affecting the trials’ design and reporting. In 2000 ClinicalTrials.gov data repository was developed and deployed to serve public and scientific communities with valid data on clinical trials. Later in order to increase deposited data completeness and transparency of medical research a set of restrains had been imposed making the results deposition compulsory for multiple cases.

Methods

We investigated efficiency of the results deposition and outcome reporting as well as what factors make positive impact on providing information of interest and what makes it more difficult, whether efficiency depends on what kind of institution was a trial sponsor. Data from the ClinicalTrials.gov repository has been classified based on what kind of institution a trial sponsor was. The odds ratio was calculated for results and outcome reporting by different sponsors’ class.

Results

As of 01/01/2012 118,602 clinical trials data deposits were made to the depository. They came from 9068 different sources. 35344 (29.8%) of them are assigned as FDA regulated and 25151 (21.2%) as Section 801 controlled substances. Despite multiple regulatory requirements, only about 35% of trials had clinical study results deposited, the maximum 55.56% of trials with the results, was observed for trials completed in 2008.

Conclusions

The most positive impact on depositing results, the imposed restrains made for hospitals and clinics. Health care companies showed much higher efficiency than other investigated classes both in higher fraction of trials with results and in providing at least one outcome for their trials. They also more often than others deposit results when it is not strictly required, particularly, in the case of non-interventional studies.

Background

Results showed good clinical outcomes of anterior corpectomy and fusion (ACCF) for patients with cervical spondylotic myelopathy (CSM) during a short term follow-up; however, studies assessing long term results are relatively scarce. In this study we intended to assess the long term clinical and radiographic outcomes, find out the factors that may affect the long term clinical outcome and evaluate the incidence of adjacent segment disease (ASD).

Methods

This is a retrospective study of 145 consecutive CSM patients on ACCF treatment with a minimum follow-up of 5 years. Clinical data were collected from medical and operative records. Patients were evaluated by using the Japanese Orthopedic Association (JOA) scoring system preoperatively and during the follow-up. X-rays results of cervical spine were obtained from all patients. Correlations between the long term clinical outcome and various factors were also analyzed.

Findings

Ninety-three males and fifty-two females completed the follow-up. The mean age at operation was 51.0 years, and the mean follow-up period was 102.1 months. Both postoperative sagittal segmental alignment (SSA) and the sagittal alignment of the whole cervical spine (SACS) increased significantly in terms of cervical lordosis. The mean increase of JOA was 3.8±1.3 postoperatively, and the overall recovery rate was 62.5%. Logistic regression analysis showed that preoperative duration of symptoms >12 months, high-intensity signal in spinal cord and preoperative JOA score ≤9 were important predictors of the fair recovery rate (≤50%). Repeated surgery due to ASD was performed in 7 (4.8%) cases.

Conclusions

ACCF with anterior plate fixation is a reliable and effective method for treating CSM in terms of JOA score and the recovery rate. The correction of cervical alignment and the repeated surgery rate for ASD are also considered to be satisfactory.

Background

For Comparative Effectiveness Research (CER) there is a need to develop scales for appraisal of available clinical research. Aims were to 1) test the feasibility of applying the pragmatic-explanatory continuum indicator summary tool and the six CER defining characteristics of the Institute of Medicine to RCTs of acupuncture for treatment of low back pain, and 2) evaluate the extent to which the evidence from these RCTs is relevant to clinical and health policy decision making.

Methods

We searched Medline, the AcuTrials™ Database to February 2011 and reference lists and included full-report randomized trials in English that compared needle acupuncture with a conventional treatment in adults with non-specific acute and/or chronic low back pain and restricted to those with ≥30 patients in the acupuncture group. Papers were evaluated by 5 raters.

Principal Findings

From 119 abstracts, 44 full-text publications were screened and 10 trials (4,901 patients) were evaluated. Due to missing information and initial difficulties in operationalizing the scoring items, the first scoring revealed inter-rater and inter-item variance (intraclass correlations 0.02–0.60), which improved after consensus discussions to 0.20–1.00. The 10 trials were found to cover the efficacy-effectiveness continuum; those with more flexible acupuncture and no placebo control scored closer to effectiveness.

Conclusion

Both instruments proved useful, but need further development. In addition, CONSORT guidelines for reporting pragmatic trials should be expanded. Most studies in this review already reflect the movement towards CER and similar approaches can be taken to evaluate comparative effectiveness relevance of RCTs for other treatments.

Background

The $1.1 billion investment in comparative effectiveness research will reshape the evidence-base supporting decisions about treatment effectiveness, safety, and cost. Defining the current prevalence and characteristics of comparative effectiveness (CE) research will enable future assessments of the impact of this program.

Methods

We conducted an observational study of clinical trials addressing priority research topics defined by the Institute of Medicine and conducted in the US between 2007 and 2010. Trials were identified in ClinicalTrials.gov. Main outcome measures were the prevalence of comparative effectiveness research, nature of comparators selected, funding sources, and impact of these factors on results.

Results

231 (22.3%; 95% CI 19.8%–24.9%) studies were CE studies and 804 (77.7%; 95% CI, 75.1%–80.2%) were non-CE studies, with 379 (36.6%; 95% CI, 33.7%–39.6%) employing a placebo control and 425 (41.1%; 95% CI, 38.1%–44.1%) no control. The most common treatments examined in CE studies were drug interventions (37.2%), behavioral interventions (28.6%), and procedures (15.6%). Study findings were favorable for the experimental treatment in 34.8% of CE studies and greater than twice as many (78.6%) non-CE studies (P<0.001). CE studies were more likely to receive government funding (P = 0.003) and less likely to receive industry funding (P = 0.01), with 71.8% of CE studies primarily funded by a noncommercial source. The types of interventions studied differed based on funding source, with 95.4% of industry trials studying a drug or device. In addition, industry-funded CE studies were associated with the fewest pediatric subjects (P<0.001), the largest anticipated sample size (P<0.001), and the shortest study duration (P<0.001).

Conclusions

In this sample of studies examining high priority areas for CE research, less than a quarter are CE studies and the majority is supported by government and nonprofits. The low prevalence of CE research exists across CE studies with a broad array of interventions and characteristics.

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.

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.

Background

The Office of Inspector General of the Department of Health and Human Services (OIG-DHHS) issued a report which showed explosive growth and also raised questions of lack of medical necessity and/or indications for facet joint injection services in 2006.

The purpose of the study was to determine trends of frequency and cost of facet joint interventions in managing spinal pain.

Methods

This analysis was performed to determine trends of frequency and cost of facet joint

Interventions in managing spinal pain, utilizing the annual 5% national sample of the Centers for

Medicare and Medicaid Services (CMS) for 1997, 2002, and 2006.

Outcome measures included overall characteristics of Medicare beneficiaries receiving facet joint interventions, utilization of facet joint interventions by place of service, by specialty, reimbursement characteristics, and other variables.

Results

From 1997 to 2006, the number of patients receiving facet joint interventions per 100,000

Medicare population increased 386%, facet joint visits increased 446%, and facet joint interventions increased 543%. The increases were higher in patients aged less than 65 years compared to those 65 or older with patients increasing 504% vs. 355%, visits increasing 587% vs. 404%, and services increasing 683% vs. 498%.

Total expenditures for facet joint interventions in the Medicare population increased from over $229 million in 2002 to over $511 million in 2006, with an overall increase of 123%. In 2006, there was a 26.8-fold difference in utilization of facet joint intervention services in Florida compared to the state with the lowest utilization - Hawaii.

There was an annual increase of 277.3% in the utilization of facet joint interventions by general physicians, whereas a 99.5% annual increase was seen for nurse practitioners (NPs) and certified registered nurse anesthetists (CRNAs) from 2002 to 2006. Further, in Florida, 47% of facet joint interventions were performed by general physicians.

Conclusions

The reported explosive growth of facet joint interventions in managing spinal pain in certain regions and by certain specialties may result in increased regulations and scrutiny with reduced access.

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.

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.

Background

Facet joints are a clinically important source of chronic cervical, thoracic, and lumbar spine pain. The purpose of this study was to systematically evaluate the prevalence of facet joint pain by spinal region in patients with chronic spine pain referred to an interventional pain management practice.

Methods

Five hundred consecutive patients with chronic, non-specific spine pain were evaluated. The prevalence of facet joint pain was determined using controlled comparative local anesthetic blocks (1% lidocaine or 1% lidocaine followed by 0.25% bupivacaine), in accordance with the criteria established by the International Association for the Study of Pain (IASP). The study was performed in the United States in a non-university based ambulatory interventional pain management setting.

Results

The prevalence of facet joint pain in patients with chronic cervical spine pain was 55% 5(95% CI, 49% – 61%), with thoracic spine pain was 42% (95% CI, 30% – 53%), and in with lumbar spine pain was 31% (95% CI, 27% – 36%). The false-positive rate with single blocks with lidocaine was 63% (95% CI, 54% – 72%) in the cervical spine, 55% (95% CI, 39% – 78%) in the thoracic spine, and 27% (95% CI, 22% – 32%) in the lumbar spine.

Conclusion

This study demonstrated that in an interventional pain management setting, facet joints are clinically important spinal pain generators in a significant proportion of patients with chronic spinal pain. Because these patients typically have failed conservative management, including physical therapy, chiropractic treatment and analgesics, they may benefit from specific interventions designed to manage facet joint pain.

Background

Fluoroscopic guidance is frequently utilized in interventional pain management. The major purpose of fluoroscopy is correct needle placement to ensure target specificity and accurate delivery of the injectate. Radiation exposure may be associated with risks to physician, patient and personnel. While there have been many studies evaluating the risk of radiation exposure and techniques to reduce this risk in the upper part of the body, the literature is scant in evaluating the risk of radiation exposure in the lower part of the body.

Methods

Radiation exposure risk to the physician was evaluated in 1156 patients undergoing interventional procedures under fluoroscopy by 3 physicians. Monitoring of scattered radiation exposure in the upper and lower body, inside and outside the lead apron was carried out.

Results

The average exposure per procedure was 12.0 ± 9.8 seconds, 9.0 ± 0.37 seconds, and 7.5 ± 1.27 seconds in Groups I, II, and III respectively. Scatter radiation exposure ranged from a low of 3.7 ± 0.29 seconds for caudal/interlaminar epidurals to 61.0 ± 9.0 seconds for discography. Inside the apron, over the thyroid collar on the neck, the scatter radiation exposure was 68 mREM in Group I consisting of 201 patients who had a total of 330 procedures with an average of 0.2060 mREM per procedure and 25 mREM in Group II consisting of 446 patients who had a total of 662 procedures with average of 0.0378 mREM per procedure. The scatter radiation exposure was 0 mREM in Group III consisting of 509 patients who had a total 827 procedures. Increased levels of exposures were observed in Groups I and II compared to Group III, and Group I compared to Group II.

Groin exposure showed 0 mREM exposure in Groups I and II and 15 mREM in Group III. Scatter radiation exposure for groin outside the apron in Group I was 1260 mREM and per procedure was 3.8182 mREM. In Group II the scatter radiation exposure was 400 mREM and with 0.6042 mREM per procedure. In Group III the scatter radiation exposure was 1152 mREM with 1.3930 mREM per procedure.

Conclusion

Results of this study showed that scatter radiation exposure to both the upper and lower parts of the physician's body is present. Protection was offered by traditional measures to the upper body only.