Efficacy of tramadol in treatment of chronic low back pain.
Bibliographic record
Abstract
OBJECTIVE: To evaluate the efficacy and safety of tramadol in the treatment of chronic low back pain. METHODS: A 3 phase trial: (1) a washout/screening phase; (2) a 3 week, open label, run-in phase; and (3) a 4 week, randomized, placebo controlled, double blind treatment phase. Three hundred eighty outpatients between 21 and 79 years with chronic low back pain with no or a distant history of back surgery enrolled in the open label phase and were treated with tramadol up to 400 mg/day. At the end of the open label phase, patients who tolerated tramadol and perceived benefit from it were randomized to continue treatment with tramadol or to convert to placebo in the double blind phase. Reasons for discontinuing from the open label phase included adverse events, 78 patients (20.5%); drug ineffective, 23 patients (6.1%); and other reasons, 25 patients (6.6%). Two hundred fifty-four patients entered the double blind phase, during which the daily dose was maintained within the range 200-400 mg tramadol or equivalent amount of placebo. The primary outcome measure in the double blind phase was the time to discontinuation due to inadequate pain relief. RESULTS: The distribution of time to therapeutic failure was significantly (p < or = 0.0001) different in the tramadol group compared to placebo. Kaplan-Meier estimate of the cumulative discontinuation rate due to therapeutic failure was 20.7% in the tramadol group and 51.3% in the placebo group. There were significantly lower (p < or = 0.0001) mean pain visual analog scores (10 cm scale) among tramadol patients (3.5 cm) compared to placebo patients (5.1 cm) at the final visit of the double blind phase. Tramadol patients scored significantly better on the McGill Pain Questionnaire (p = 0.0007) and the Roland Disability Questionnaire (p = 0.0001). Five of 127 tramadol treated patients and 6/127 placebo treated patients discontinued treatment during the double blind phase due to an adverse event. Commonly reported adverse events with tramadol included nausea, dizziness, somnolence, and headache. CONCLUSION: Among patients who tolerated it well, tramadol was effective for the treatment of chronic low back pain.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".