Articles: low-back-pain.
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Randomized Controlled Trial Clinical Trial
A placebo-controlled randomized clinical trial of nortriptyline for chronic low back pain.
To assess the efficacy of nortriptyline, a tricyclic antidepressant, as an analgesic in chronic back pain without depression, we conducted a randomized, double-blind, placebo-controlled, 8-week trial in 78 men recruited from primary care and general orthopedic settings, who had chronic low back pain (pain at T-6 or below on a daily basis for 6 months or longer). Of these 57 completed the trial; of the 21 who did not complete, four were withdrawn because of adverse effects. The intervention consisted of inert placebo or nortriptyline titrated to within the therapeutic range for treating major depression (50-150 ng/ml). ⋯ Also, completers with radicular pain on nortriptyline (n = 5) had significantly (P < 0.05) better analgesia and overall outcome than did those on placebo (n = 6). The results suggest noradrenergic mechanisms are relevant to analgesia in back pain. This modest reduction in pain intensity suggests that physicians should carefully weigh the risks and benefits of nortriptyline in chronic back pain without depression.
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Arzneimittel Forsch · Jun 1998
Randomized Controlled Trial Comparative Study Clinical TrialComparison of the efficacy and tolerability of a paracetamol/codeine fixed-dose combination with tramadol in patients with refractory chronic back pain.
Fifty-five patients suffering from refractory chronic back pain took part in a double-blind, multiple-dose, randomised, cross-over study to compare the efficacy and tolerability of a fixed-dose capsule preparation containing 500 mg paracetamol (CAS 103-90-2) and 30 mg codeine phosphate 1/2 H2O (CAS 41444-62-6) (talvosilen forte, test preparation) with a reference capsule preparation containing 50 mg tramadol hydrochloride (CAS 22204-88-2), in a regimen of two capsules 8-hourly. There were two treatment periods of up to 7 days each. ⋯ The test preparation was at least as efficacious as the reference in the treatment of back pain (81% of patients experienced good or satisfactory pain relief). 81% of patients tolerated the test well compared to only 69% receiving the reference, as per protocol analysis. The results of this study suggest that the test product is at least as efficacious as tramadol in the treatment of patients with refractory chronic back pain, whilst being better tolerated.
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Arch Phys Med Rehabil · May 1998
Randomized Controlled Trial Clinical TrialCombined exercise and motivation program: effect on the compliance and level of disability of patients with chronic low back pain: a randomized controlled trial.
To assess the effect of a combined exercise and motivation program on the compliance and level of disability of patients with chronic and recurrent low back pain. ⋯ The combined exercise and motivation program increased the rate of attendance at scheduled physical therapy sessions, ie, short-term compliance, and reduced disability and pain levels by the 12-month follow-up. However, there was no difference between the motivation and control groups with regard to long-term exercise compliance.
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Randomized Controlled Trial Clinical Trial
A fitness programme for patients with chronic low back pain: 2-year follow-up of a randomised controlled trial.
The aim of this study was to assess the long-term effect of a supervised fitness programme on patients with chronic low back pain. The design of the study was a single blind randomised controlled trial with follow-up, by postal questionnaire, 2 years after intervention. The Oswestry Low Back Pain Disability Index was used as the outcome measure to assess daily activity affected by back pain. ⋯ Between group comparisons demonstrated a statistically significant difference in disability scores between the treatment and control group (mean difference 5.8, 95% confidence interval 0.3, 11.4 P < 0.04). This study supports the current trend towards a more active treatment approach to low back pain. We have demonstrated clinical effectiveness of a fitness programme 2 years after treatment but this needs to be replicated in a larger study which should include a cost effectiveness analysis, further analysis of objective functional status and a placebo intervention group.
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Randomized Controlled Trial Clinical Trial
Functional restoration for chronic low back pain. Two-year follow-up of two randomized clinical trials.
Two randomized, prospective clinical trials involving 238 chronic low back disability patients were carried out. Results at 2-year follow-up are presented. ⋯ The functional restoration program seems effective in various parameters compared with the less intensive programs, but the differences in outcome in the two parallel studies indicate the necessity of testing a treatment program in different settings, in that the statistical variation may be a major factor in results of different studies.