Connie Kurihara

Randomized Placebo-Controlled Study Evaluating Lateral Branch Radiofrequency Denervation for Sacroiliac Joint Pain

Background:Sacroiliac joint pain is a challenging condition accounting for approximately 20% of cases of chronic low back pain. Currently, there are no effective long-term treatment options for sacroiliac joint pain. Methods:A randomized placebo-controlled study was conducted in 28 patients with injection-diagnosed sacroiliac joint pain. Fourteen patients received L4–L5 primary dorsal rami and S1–S3 lateral branch radiofrequency denervation using cooling-probe technology after a local anesthetic block, and 14 patients received the local anesthetic block followed by placebo denervation. Patients who did not respond to placebo injections crossed over and were treated with radiofrequency denervation using conventional technology. Results:One, 3, and 6 months after the procedure, 11 (79%), 9 (64%), and 8 (57%) radiofrequency-treated patients experienced pain relief of 50% or greater and significant functional improvement. In contrast, only 2 patients (14%) in the placebo group experienced significant improvement at their 1-month follow-up, and none experienced benefit 3 months after the procedure. In the crossover group (n = 11), 7 (64%), 6 (55%), and 4 (36%) experienced improvement 1, 3, and 6 months after the procedure. One year after treatment, only 2 patients (14%) in the treatment group continued to demonstrate persistent pain relief. Conclusions:These results provide preliminary evidence that L4 and L5 primary dorsal rami and S1–S3 lateral branch radiofrequency denervation may provide intermediate-term pain relief and functional benefit in selected patients with suspected sacroiliac joint pain. Larger studies are needed to confirm these results and to determine the optimal candidates and treatment parameters for this poorly understood disorder.

Diagnoses and factors associated with medical evacuation and return to duty for service members participating in Operation Iraqi Freedom or Operation Enduring Freedom: a prospective cohort study

BACKGROUND Anticipation of the types of injuries that occur in modern warfare is essential to plan operations and maintain a healthy military. We aimed to identify the diagnoses that result in most medical evacuations, and ascertain which demographic and clinical variables were associated with return to duty. METHODS Demographic and clinical data were prospectively obtained for US military personnel who had been medically evacuated from Operation Iraqi Freedom or Operation Enduring Freedom (January, 2004-December, 2007). Diagnoses were categorised post hoc according to the International Classification of Diseases codes that were recorded at the time of transfer. The primary outcome measure was return to duty within 2 weeks. FINDINGS 34 006 personnel were medically evacuated, of whom 89% were men, 91% were enlisted, 82% were in the army, and 86% sustained an injury in Iraq. The most common reasons for medical evacuation were: musculoskeletal and connective tissue disorders (n=8104 service members, 24%), combat injuries (n=4713, 14%), neurological disorders (n=3502, 10%), psychiatric diagnoses (n=3108, 9%), and spinal pain (n=2445, 7%). The factors most strongly associated with return to duty were being a senior officer (adjusted OR 2.01, 95% CI 1.71-2.35, p<0.0001), having a non-battle-related injury or disease (3.18, 2.77-3.67, p<0.0001), and presenting with chest or abdominal pain (2.48, 1.61-3.81, p<0.0001), a gastrointestinal disorder (non-surgical 2.32, 1.51-3.56, p=0.0001; surgical 2.62, 1.69-4.06, p<0.0001), or a genitourinary disorder (2.19, 1.43-3.36, p=0.0003). Covariates associated with a decreased probability of return to duty were serving in the navy or coast guard (0.59, 0.45-0.78, p=0.0002), or marines (0.86, 0.77-0.96, p=0.0083); and presenting with a combat injury (0.27, 0.17-0.44, p<0.0001), a psychiatric disorder (0.28, 0.18-0.43, p<0.0001), musculoskeletal or connective tissue disorder (0.46, 0.30-0.71, p=0.0004), spinal pain (0.41, 0.26-0.63, p=0.0001), or other wound (0.54, 0.34-0.84, p=0.0069). INTERPRETATION Implementation of preventive measures for service members who are at highest risk of evacuation, forward-deployed treatment, and therapeutic interventions could reduce the effect of non-battle-related injuries and disease on military readiness. FUNDING John P Murtha Neuroscience and Pain Institute, and US Army Regional Anesthesia and Pain Management Initiative.

Randomized, Double-blind, Placebo-controlled, Dose- response, and Preclinical Safety Study of Transforaminal Epidural Etanercept for the Treatment of Sciatica

Background:Recent evidence implicates the inflammatory cytokine tumor necrosis factor as a major cause of radiculopathy. Yet, whereas open-label studies with systemically delivered tumor necrosis factor inhibitors have yielded positive results, a placebo-controlled study failed to demonstrate efficacy. One variable that may have contributed to poor outcomes is low drug levels at the site of nerve inflammation. To date, no studies have evaluated the efficacy or safety of epidurally administered anti-tumor necrosis factor agents. Methods:A double-blind, placebo-controlled, dose-response study was conducted to evaluate an epidural tumor necrosis factor inhibitor. Twenty-four patients with subacute lumbosacral radiculopathy were randomly assigned to receive two transforaminal epidural injections of 2, 4, or 6 mg of entanercept 2 weeks apart in successive groups of eight. In each group, two patients received epidural saline. A parallel epidural canine safety study was conducted using the same injection doses and paradigm as in the clinical study. Results:The animal and human safety studies revealed no behavioral, neurologic, or histologic evidence of drug-related toxicity. In the clinical arm, significant improvements in leg and back pain were collectively noted for the etanercept-treated patients, but not for the saline group, one month after treatment. One patient in the saline group (17%), six patients in the 2-mg group (100%), and four patients each in the 4-mg and 6-mg groups (67%) reported at least 50% reduction in leg pain and a positive global perceived effect one month after treatment. Six months after treatment, the beneficial effects persisted in all but one patient. Conclusion:Epidural entanercept holds promise as a treatment for lumbosacral radiculopathy.

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

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

6,286,

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

17,142, and

Comparison of fluoroscopically guided and blind corticosteroid injections for greater trochanteric pain syndrome: multicentre randomised controlled 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.

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.

Epidural steroid injections, conservative treatment, or combination treatment for cervical radicular pain: a multicenter, randomized, comparative-effectiveness study.

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.

Randomized Study Assessing the Accuracy of Cervical Facet Joint Nerve (Medial Branch) Blocks Using Different Injectate Volumes

Objective To determine whether fluoroscopic guidance improves outcomes of injections for greater trochanteric pain syndrome. Design Multicentre double blind randomised controlled study. Setting Three academic and military treatment facilities in the United States and Germany. Participants 65 patients with a clinical diagnosis of greater trochanteric pain syndrome. Interventions Injections of corticosteroid and local anaesthetic into the trochanteric bursa, using fluoroscopy (n=32) or landmarks (that is, “blind” injections; n=33) for guidance. Main outcome measures Primary outcome measures: 0-10 numerical rating scale pain scores at rest and with activity at one month (positive categorical outcome predefined as ≥50% pain reduction either at rest or with activity, coupled with positive global perceived effect). Secondary outcome measures included Oswestry disability scores, SF-36 scores, reduction in drug use, and patients’ satisfaction. Results No differences in outcomes occurred favouring either the fluoroscopy or blind treatment groups. One month after injection the average pain scores were 2.7 at rest and 5.0 with activity in the fluoroscopy group compared with 2.2 and 4.0 in the blind injection group. Three months after the injection, 15 (47%) patients in the blind group and 13 (41%) in the fluoroscopy group continued to have a positive outcome. Conclusion Although using fluoroscopic guidance dramatically increases treatment costs for greater trochanteric pain syndrome, it does not necessarily improve outcomes. Trial registration Clinical trials NCT00480675