Thomas M. Larkin

Multicenter, Randomized, Comparative Cost-effectiveness Study Comparing 0, 1, and 2 Diagnostic Medial Branch (Facet Joint Nerve) Block Treatment Paradigms before Lumbar Facet Radiofrequency Denervation

Background:Among patients presenting with axial low back pain, facet arthropathy accounts for approximately 10–15% of cases. Facet interventions are the second most frequently performed procedures in pain clinics across the United States. Currently, there are no uniformly accepted criteria regarding how best to select patients for radiofrequency denervation. Methods:A randomized, multicenter study was performed in 151 subjects with suspected lumbar facetogenic pain comparing three treatment paradigms. Group 0 received radiofrequency denervation based solely on clinical findings; group 1 underwent denervation contingent on a positive response to a single diagnostic block; and group 2 proceeded to denervation only if they obtained a positive response to comparative blocks done with lidocaine and bupivacaine. A positive outcome was predesignated as ≥50% pain relief coupled with a positive global perceived effect persisting for 3 months. Results:In group 0, 17 patients (33%) obtained a successful outcome at 3 months versus eight patients (16%) in group 1 and 11 (22%) patients in group 2. Denervation success rates in groups 0, 1, and 2 were 33, 39, and 64%, respectively. Pain scores and functional capacity were significantly lower at 3 months but not at 1 month in group 2 subjects who proceeded to denervation compared with patients in groups 0 and 1. The costs per successful treatment in groups 0, 1, and 2 were

Lumbar discography: A comprehensive review of outcome studies, diagnostic accuracy, and principles

6,286,

Risk factors for failure and complications of intradiscal electrothermal therapy: a pilot study.

17,142, and

Epidural Steroids, Etanercept, or Saline in Subacute Sciatica: A Multicenter, Randomized Trial

15,241, respectively. Conclusions:Using current reimbursement scales, these findings suggest that proceeding to radiofrequency denervation without a diagnostic block is the most cost-effective treatment paradigm.

A double-blind, placebo-controlled, dose-response pilot study evaluating intradiscal etanercept in patients with chronic discogenic low back pain or lumbosacral radiculopathy.

Background and Objectives: Since its advent more than 50 years ago, the use of discography has been mired in controversy. The purpose of this review is to provide a clinical overview of lumbar discography and discogenic back pain, with special emphasis on determining the accuracy of discography and whether or not the procedure improves outcomes for surgery. Methods: Material for this review was obtained from a MEDLINE search conducted from 1951 thru September 2004, bibliographic references, book chapters, and conference proceedings. Results: Based on a large number of comparative studies, plain discography is less accurate than magnetic resonance imaging in diagnosing lumbar herniated nucleus pulposus and comparable or slightly more sensitive in detecting degenerative disc disease. For disc degeneration, CT discography remains the gold standard for diagnosis. There are very few studies comparing surgical outcomes between patients who have undergone preoperative provocative discography and those who have not. What little evidence exists is conflicting. Before disc replacement surgery, approximately half the studies have used preoperative discography. A comparison of outcomes did not reveal any significant difference between the 2 groups but none of the studies was controlled, and they used different outcome measures, follow-up periods, and surgical techniques. Because all intradiscal electrothermal therapy (IDET) studies have used discography before surgery, no conclusions can be drawn regarding its effects on outcome. Conclusions: Although discography, especially combined with CT scanning, may be more accurate than other radiologic studies in detecting degenerative disc disease, its ability to improve surgical outcomes has yet to be proven. In the United States and Europe, there are inconsistencies in the use of lumbar discography such that it is routinely used before IDET, yet only occasionally used before spinal fusion.

Presentation, diagnoses, mechanisms of injury, and treatment of soldiers injured in operation Iraqi freedom : An epidemiological study conducted at two military pain management centers

Study Design. A bi-institutional, retrospective clinical data analysis. Objectives. To determine risk factors for failure and complications of intradiscal electrothermal therapy, a treatment for discogenic back pain. Summary of the Background Data. Intradiscal electrothermal therapy is a relatively new treatment for discogenic back pain. Though previous studies have shown it to be an effective treatment, there are few published studies examining complications and none examining risk factors for failure. Methods. The authors treated 79 patients with discogenic back pain using intradiscal electrothermal therapy. Complications were assessed by patient report and, when indicated, further diagnostic testing. Success or failure was determined by visual analogue pain scores at 6-month follow-up. Variables examined for their relationship to failure and complications were age, sex, duration of pain, number of levels heated, smoking history, diabetes, obesity, leg pain, and previous back surgery. Results. Forty-eight percent of patients reported more than 50% pain relief at their 6-month follow-up. There were eight complications (10%), most of which were self-limited and transient. The only risk factor associated with intradiscal electrothermal therapy failure was obesity (P = 0.01). Whereas 54% of nonobese patients reported good pain relief at 6 months, only one out of 10 obese patients had successful intradiscal electrothermal therapy. The obese patients in our study were more likely to have a complication from intradiscal electrothermal therapy than they were to obtain pain relief. Conclusion. The only risk factor found to be associated with IDET outcome was obesity, which was a strong predictor of failure. Obesity should be considered a relative contraindication to performing IDET.

Nucleoplasty with or without intradiscal electrothermal therapy (IDET) as a treatment for lumbar herniated disc

BACKGROUND Active surveillance (AS) and watchful waiting (WW) have been proposed as management strategies for low-risk, localized prostate cancer. PURPOSE To systematically review strategies for observational management of prostate cancer (AS or WW), factors affecting their utilization, and comparative effectiveness of observational management versus immediate treatment with curative intent. DATA SOURCES MEDLINE and Cochrane databases (from inception to August 2011). STUDY SELECTION Screened abstracts and reviewed full-text publications to identify eligible studies. DATA EXTRACTION One reviewer extracted data, and another verified quantitative data. Two independent reviewers rated study quality and strength of evidence for comparative effectiveness. DATA SYNTHESIS Sixteen independent cohorts defined AS, 42 studies evaluated factors that affect the use of observational strategies, and 2 evidence reports and 22 recent studies reported comparisons of WW versus treatment with curative intent. The most common eligibility criteria for AS were tumor stage (all cohorts), Gleason score (12 cohorts), prostate-specific antigen (PSA) concentration (10 cohorts), and number of biopsy cores positive for cancer (8 cohorts). For monitoring, studies used combinations of periodic PSA testing (all cohorts), digital rectal examination (14 cohorts), and rebiopsy (14 cohorts). Predictors of receiving no active treatment included older age, comorbid conditions, lower Gleason score, tumor stage, PSA concentration, and favorable risk group. No published studies compared AS with immediate treatment with curative intent. Watchful waiting was generally less effective than treatment with curative intent; however, applicability to contemporary patients may be limited. LIMITATIONS Active surveillance and WW often could not be differentiated in the reviewed studies. Published randomized trials have assessed only WW and did not enroll patients diagnosed by PSA screening. CONCLUSION Evidence is insufficient to assess whether AS is an appropriate option for men with localized prostate cancer. A standard definition of AS that clearly distinguishes it from WW is needed to clarify scientific discourse. PRIMARY FUNDING SOURCE Agency for Healthcare Research and Quality.

A giant herniated disc following intradiscal electrothermal therapy.

Background:In recent years, convincing evidence has emerged implicating tumor necrosis factor α as a causative factor in radiculopathy and discogenic back pain. But although preliminary open-label studies demonstrated promising results for the treatment of low back pain with tumor necrosis factor-α inhibitors, early optimism has been tainted by a controlled study showing no significant benefit in sciatica. To determine whether outcomes might be improved by a more direct route of administration, the authors evaluated escalating doses of intradiscal etanercept in 36 patients with chronic lumbosacral radiculopathy or discogenic low back pain. Methods:A double-blind, placebo-controlled pilot study was conducted whereby six patients received 0.1, 0.25, 0.5, 0.75, 1.0, or 1.5 mg etanercept intradiscally in each pain-generating disc. In each escalating dose group of six patients, one received placebo. A neurologic examination and postprocedure leukocyte counts were performed in all patients at 1-month follow-up visits. In patients who experienced significant improvement in pain scores and function, follow-up visits were conducted 3 and 6 months after the procedure. Results:At 1-month follow-up, no differences were found for pain scores or disability scores between or within groups for any dose range or subgroup of patients. Only eight patients remained in the study after 1 month and elected to forego further treatment. No complications were reported, and no differences were noted between preprocedure and postprocedure leukocyte counts. Conclusions:Although no serious side effects were observed in this small study, a single low dose of intradiscal etanercept does not seem to be an effective treatment for chronic radicular or discogenic low back pain.

A novel technique for delivery of epidural steroids and diagnosing the level of nerve root pathology.

In recent military conflicts the major source of soldier attrition has not been battle injuries but more mundane causes similar to those encountered in civilian life. In an effort to determine the pain conditions affecting soldiers during wartime, we conducted an observational study among 162 soldiers medically evacuated from Operation Iraqi Freedom who were referred to 2 large pain treatment centers located outside the theaters of combat. Fifty-three percent of soldiers presented with either radicular (n = 49) or axial (n = 37) low back pain, with lumbar herniated disk being the most frequently diagnosed condition (24%). The two most implicated etiologies were exacerbation of a previous pain condition treated with surgery (15%) and motor vehicle accidents(12%). Only 17% of patients were injured during battle. Seventy-two percent of soldiers received at least one nerve block/injection, the most common of which was lumbar epidural steroid administration (22%). Nonsteroidal antiinflammatory drugs were prescribed to 56% of patients, opioids to 49%, and some form of alternative therapy to 17%. Among the 49 patients in whom data were available, only 2% returned to combat duty in Iraq. With the exception of battle-related injuries, the pain conditions suffered during modern warfare seem to be similar to those encountered in civilian pain clinics. To improve the return-to-duty rate, better preventive measures and more aggressive treatment conducted in forward-deployed medical units are recommended.

A Multi-Center Analysis Evaluating Factors Associated with Spinal Cord Stimulation Outcome in Chronic Pain Patients

Background and Objective: In industrialized societies, the prevalence of radicular low back pain has exploded in recent years. The growing economic and personal costs of this challenging entity have led to the development of a wide array of new treatments, ranging from pharmacotherapy with neuropathic medications to open surgical treatment. Among the therapeutic options to emerge are a plethora of minimally invasive treatments aimed at removing nuclear material and lowering intradiscal pressure through devices inserted percutaneously into intervertebral discs. Yet there is a compelling lack of clinical evidence to support the use of these procedures. This study was undertaken to determine the treatment outcomes of 16 consecutive patients with lumbar radicular pain secondary to a herniated disc who underwent nucleoplasty as their primary therapy. Methods: Included in this series were nine patients with significant axial back pain, sitting intolerance, and positive discography who also underwent intradiscal electrothermal therapy (IDET). Among the 7 patients who only had nucleoplasty, 4 had 2 discs treated and 3 had 1 disc. In the 9 patients who also had IDET, 6 had 1 disc treated and 3 had 2 discs treated. Of the 32 total disc treatments, 20 were at L5-S1, 10 were at L4-5 and 2, one each for IDET and nucleoplasty, were at L3-4. Results: In the overall cohort, the average Visual Analogue Scale (VAS) pain score decreased from 6.7 to 5.6 at a mean follow-up of 9 months. In the seven patients who underwent only nucleoplasty, the mean VAS score decreased from 6.0 to 4.8. Only one patient reported a ≥50% reduction in pain score. Conclusions: We conclude that with use of the present selection criteria, nucleoplasty is not an effective long-term treatment for lumbar radiculopathy, either alone or with IDET. Before conducting future clinical trials, we recommend modifying these criteria to include only those patients with small (<6-mm) contained disc herniations whose annular integrity is documented by computed tomography discography and corresponding radicular symptoms confirmed by either selective nerve root blocks or electromyography and nerve conduction studies.