Randomized Double-Blind Controlled Trial Comparing the Effectiveness of Lumbar Transforaminal Epidural Injections of Particulate and Nonparticulate Corticosteroids for Lumbosacral Radicular Pain.

OBJECTIVE: To compare equivalent doses of a nonparticulate (dexamethasone) with a particulate (betamethasone) corticosteroid in lumbar transforaminal epidural steroid injections (TFESIs) in terms of pain, function, and complications. DESIGN: Fifty-six patients presenting with debilitating radicular pain were randomized in a double-blind controlled trial to receive a lumbar transforaminal injection of either dexamethasone 7.5 mg (n = 29) or betamethasone 6.0 mg (n = 27). SETTING: A pain clinic and physical medicine and rehabilitation department in two academic hospital centres. OUTCOME MEASURES: Data were collected at 1-, 3-, and 6-month follow-ups. The primary outcome was pain reduction on a visual analog scale (VAS) at 3 months. Secondary outcomes were functional improvement, as measured by the Oswestry Disability Index (ODI), and number and type of complications. RESULTS: No differences on the VAS, analyzed either as a continuous (P = 0.209) or categorical variable (≥50% (P = 0.058) or ≥75% (P = 0.865) improvement) and ODI (P = 0.181) were found between the two groups at 3 months. At 6 months, improvement of ODI score was at the limit of statistical significance in favor of dexamethasone (P = 0.050). Multivariate regression analysis, adjusting for potential confounding variables, showed that differences on the ODI became statistically significant at the 6 month follow-up, also in favor of dexamethasone (adjusted P = 0.003). No serious complications were observed in either group. CONCLUSION: According to this study, pain relief and functional improvement are similar for both dexamethasone and betamethasone at 3 months. Considering its safety profile, dexamethasone could be considered as first choice for TFESI. However, given that the study was underpowered, more research is needed to support a recommendation of systematically using dexamethasone in TFESI.

Development of a French-Canadian version of the Oswestry Disability Index: cross-cultural adaptation and validation.

STUDY DESIGN: Cross-cultural translation and psychometric testing. OBJECTIVE: To translate, culturally adapt, and validate the Oswestry Disability Index (ODI) version 2.0 for the French-Canadian population. SUMMARY OF BACKGROUND DATA: Many authors have recommended the administration of standardized instruments, rather than the creation of new scales, and advocate the adaptation of validated questionnaires in other languages. The application of these scales in different countries and by cultural groups necessitates cross-cultural adaptation. Many scales evaluate the functional incapacity resulting from low back pain. The ODI is among the most commonly used for this purpose. METHODS: The French-Canadian ODI (ODI-FC) was developed by cross-cultural adaptation following internationally recommended methodology: forward translation, back translation, expert committee revision, and clinical evaluation of the prefinal version. Psychometric testing was performed on 72 patients with chronic low back pain. The subjects were recruited from a physiatry department in a university hospital and from a private practice physiatry clinic. They came from the Montreal area. The psychometric testing included internal consistency (Cronbach α), test-retest reliability (intraclass correlation coefficient) with a time interval set at 48 hours, and construct validity, comparing the ODI-FC with the Roland-Morris Disability Questionnaire and the Quebec Back Pain Disability Scale (Pearson correlation coefficient). RESULTS: In 44.4% of the subjects, the average duration of low-back pain varied between 1 and 5 years. Average score for the ODI-FC was 29.2. Good internal consistency was found (Cronbach α = 0.88). Reliability was excellent, with intraclass correlation coefficient = 0.92 (95% confidence interval, 0.87-0.95). Construct validity results revealed excellent correlations between the ODI and the Quebec Back Pain Disability Scale (r = 0.90) and between the ODI and the Roland-Morris Disability Questionnaire (r = 0.84). CONCLUSION: Cross-cultural translation and adaptation of the ODI-FC were successful. Psychometric testing determined that the instrument was homogeneous, reliable, and valid. It could be employed in future clinical trials in Canada and possibly in other French-speaking countries.

Analgesic efficacy and safety of tramadol/ acetaminophen combination tablets (Ultracet) in treatment of chronic low back pain: a multicenter, outpatient, randomized, double blind, placebo controlled trial.

OBJECTIVE: To evaluate the analgesic efficacy and safety of tramadol 37.5 mg/acetaminophen 325 mg (tramadol/APAP) combination tablets for treatment of chronic low back pain (LBP). METHODS: This 91 day, multicenter, outpatient, randomized, double blind, placebo controlled study enrolled 338 patients with chronic LBP requiring daily medication for > or = 3 months. Patients with at least moderate pain [pain visual analog scale (VAS) with scores > or = 40/100 mm] after washout were randomized to tramadol/APAP or placebo. After a 10 day titration, patients received 1 or 2 tablets QID. Primary outcome measure was final pain VAS score. Secondary measures included pain relief, quality of life and physical functioning, efficacy failure, and overall medication assessments. RESULTS: In total, 336 intent-to-treat patients received tramadol/APAP (n = 167) or placebo (n = 169). Mean baseline pain VAS score was 67.8. Intent-to-treat analysis showed significantly better mean final pain VAS scores (47.4 vs 62.9; p < 0.001) and mean final pain relief scores (1.8 vs 0.7; p < 0.001) for tramadol/APAP than for placebo. Roland Disability Questionnaire scores and physical-related subcategories of the McGill Pain Questionnaire and the Medical Outcome Study Short Form-36 Health Survey were significantly better for tramadol/APAP patients. More patients rated tramadol/APAP as "very good" or "good" than placebo (63.6 vs 25.2%; p < 0.001). Kaplan-Meier estimates of cumulative discontinuation rates due to efficacy failures were 22.9% (tramadol/APAP) vs 54.7% (placebo; p < 0.001). The most common treatment related adverse events with tramadol/APAP were nausea (12.0%), dizziness (10.8%), and constipation (10.2%). Average daily dose of tramadol/APAP was 4.2 tablets (tramadol 158 mg/APAP 1369 mg). CONCLUSION: Tramadol 37.5 mg/APAP 325 mg combination tablets show efficacy in pain reduction, in measures of physical functioning and quality of life, and in overall medication assessments, with a tolerability profile comparable with other opioids used for the treatment of chronic LBP.