Abstract | OBJECTIVE: 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.
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Authors | Paul M Peloso, Luc Fortin, André Beaulieu, Marc Kamin, Norman Rosenthal, Protocol TRP-CAN-1 Study Group |
Journal | The Journal of rheumatology
(J Rheumatol)
Vol. 31
Issue 12
Pg. 2454-63
(Dec 2004)
ISSN: 0315-162X [Print] Canada |
PMID | 15570651
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Analgesics, Non-Narcotic
- Drug Combinations
- Ultracet
- Acetaminophen
- Tramadol
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Topics |
- Acetaminophen
(administration & dosage)
- Adult
- Aged
- Ambulatory Care
- Analgesics, Non-Narcotic
(administration & dosage)
- Chronic Disease
- Dose-Response Relationship, Drug
- Double-Blind Method
- Drug Administration Schedule
- Drug Combinations
- Female
- Follow-Up Studies
- Humans
- Low Back Pain
(diagnosis, drug therapy)
- Male
- Middle Aged
- Pain Measurement
- Probability
- Reference Values
- Severity of Illness Index
- Tramadol
(administration & dosage)
- Treatment Outcome
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