Articles: back-pain.
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Clinical therapeutics · Mar 1990
Randomized Controlled Trial Comparative Study Clinical TrialCyclobenzaprine and naproxen versus naproxen alone in the treatment of acute low back pain and muscle spasm.
Two groups of 20 patients each, with mild to moderate acute low back pain with associated muscle spasm of ten days' duration or less, were treated with a combination of cyclobenzaprine and naproxen or naproxen alone in a randomized, 14-day open-label trial. Cyclobenzaprine was added to the naproxen regimen as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful, musculoskeletal conditions. The clinical characteristics of each study group, including the number of worker's compensation patients, were comparable. ⋯ There were trends toward faster resolution of functional deficits and pain with combined therapy. Combination therapy was associated with more side effects, due primarily to drowsiness from the cyclobenzaprine. The results of this study demonstrated that patients with muscle spasm associated with acute low back strain benefited from the use of combination therapy consisting of a nonsteroidal anti-inflammatory agent (naproxen) and a muscle relaxant (cyclobenzaprine).
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Am J Phys Med Rehabil · Feb 1990
Randomized Controlled Trial Clinical TrialCan trials of physical treatments be blinded? The example of transcutaneous electrical nerve stimulation for chronic pain.
Therapeutic trials often attempt to "blind" patient and investigator to the true nature of treatments received, reducing the influences of conscious or subconscious prejudices. In drug trials, this is accomplished with placebo tablets, but blinding in trials of physical treatments is more problematic. This issue arose in a clinical trial of transcutaneous electrical nerve stimulation (TENS) for patients with chronic low back pain. ⋯ Clinicians guessed treatments correctly 61% of the time (as opposed to 50% expected by chance), again suggesting partial success in blinding. These efforts at blinding may partly explain the negative trial results for TENS efficacy. We conclude that complete blinding is difficult to achieve because of sensory difference in treatment and unintended communication between patient and examiner.(ABSTRACT TRUNCATED AT 250 WORDS)
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Klinische Wochenschrift · Jan 1990
Randomized Controlled Trial Comparative Study Clinical Trial[Reduced diclofenac administration by B vitamins: results of a randomized double-blind study with reduced daily doses of diclofenac (75 mg diclofenac versus 75 mg diclofenac plus B vitamins) in acute lumbar vertebral syndromes].
Pain syndromes of the lumbar spine are one of the main problems in orthopedic practice. The therapeutic effect of NSAIDs is not subject to doubt in this connection. But considering that the application of NSAIDs is frequently associated with side effects, a reduction of dosage would be to the patient's benefit. ⋯ There was the option to terminate therapy in the trial after 3-4 days in the case of total pain relief. 45 patients could stop the treatment due to remission of symptoms. 30 patients belonged to the combination therapy group, the other 15 took diclofenac alone; this difference is statistically significant (p less than 0.05). All parameters concerning pain relief and movement of the vertebral column showed statistically significant differences in favour of the B-vitamin-diclofenac-combination, too. The results document the positive influence of B-vitamins on painful vertebral syndromes and indicate that B-vitamins contribute to saving of NSAIDs by shortening the treatment time and reducing daily NSAID-dosage.
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Klinische Wochenschrift · Jan 1990
Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial[Results of a double-blind study of diclofenac + vitamin B1, B6, B12 versus diclofenac in patients with acute pain of the lumbar vertebrae. A multicenter study].
Several clinical trials have shown that the duration of treatment of painful vertebral syndromes can be shortened by using a combination of vitamins B1, B6, B12 and diclofenac instead of diclofenac. In addition, a more efficient pain relief could be achieved by the combination therapy. In order to confirm these results, we compared the clinical efficacy of diclofenac (25 mg) and a combination preparation with diclofenac (25 mg) plus vitamins B1 (thiamine nitrate 50 mg), B6 (pyridoxine hydrochloride 50 mg) and B12 (cyanocobalamin 0.25 mg) in a multicentric randomized double-blind study including 418 patients. ⋯ The differences in favour of the B-vitamin-diclofenac-combination were statistically significant in patients with severe pain at the beginning of therapy. Considering undesirable side-effects (symptoms in 70 out of 418 patients) there were no significant differences between the two medications. This clinical trial provides further evidence that the combination therapy with diclofenac plus B-vitamins is more effective than diclofenac alone for the treatment of painful vertebral syndromes.
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Scand J Rehabil Med · Jan 1990
Randomized Controlled Trial Clinical TrialA controlled study on the outcome of inpatient and outpatient treatment of low back pain. Part III. Long-term follow-up of pain, disability, and compliance.
The long-term outcome results of inpatient and outpatient treatment of low back pain (LBP) were studied in 476 subjects (aged 35-54, 63% men) randomly assigned to three study groups: inpatients (n = 157), outpatients (n = 159), and controls (n = 160). The study included changes in the severity of low back pain, grade and disability, compliance with self-care, data on disability pensions, and days of sickness allowance during a 2.5-year follow-up period. These variables were used as outcome criteria. ⋯ During the whole 2.5-year follow-up compliance with self-care was better in the two treated groups, especially in the inpatients. Days of sickness allowance had increased somewhat more in the controls than in the inpatients during the follow-up. No differences between the groups were found in the number of disability pensions granted.