[Therapy of acute lumbovertebral syndromes through optimal muscle relaxation using diazepam. Results of a double-blind study on 68 cases]. A controlled clinical trial of a muscle relaxant analgesic combination in the treatment of acute lumbago. Tizanidine and ibuprofen in acute low-back pain: results of a double-blind multicentre study in general practice. A multicentre placebo-controlled study in general practice to evaluate the efficacy and safety of tizanidine in acute low-back pain. Cyclobenzaprine hydrochloride effect on skeletal muscle spasm in the lumbar region and neck: two double-blind controlled clinical and laboratory studies. Orphenadrin-paracetamol in backache-a double-blind controlled trial. Comparison of carisoprodol, butabarbital, and placebo in treatment of the low back syndrome. Baclofen for the treatment of acute low-back syndrome. A double-blind comparison with placebo. Comparison of the effect of diazepam and levomepromazine on pain in patients with acute lumbago-sciatica. Efficacy and tolerance of repeated oral doses of tolperisone hydrochloride in the treatment of painful reflex muscle spasm: results of a prospective placebo-controlled double-blind trial. Diazepam in backache. A double-blind controlled trial. Cyclobenzaprine and naproxen versus naproxen alone in the treatment of acute low back pain and muscle spasm. Mefenamic acid, chlormezanone-paracetamol, ethoheptazine-aspirin-meprobamate: a comparative study in acute low back pain. A new skeletal muscle relaxant (DS 103-282) compared to diazepam in the treatment of muscle spasm of local origin.
nan nan This study reports on 105 patients with acute low-back pain given tizanidine (4 mg three times daily) plus ibuprofen (400 mg three times daily) or placebo plus ibuprofen (400 mg three times daily). Patients assessed their pain using visual analogue scales in a daily diary and the doctor assessed their condition at baseline and on days 3 and 7. Both groups were treated effectively, but earlier improvement occurred in patients given tizanidine/ibuprofen, particularly regarding pain at night and at rest. Doctors assessed the helpfulness of treatment: tizanidine/ibuprofen was significantly better than placebo/ibuprofen at day 3 (P = 0.05). Significant differences between treatments in favour of tizanidine/ibuprofen occurred in patients with moderate and severe pain at night (P less than 0.05), at rest (P less than 0.05) and those with moderate or severe sciatica (P less than 0.05). Significantly more patients given placebo/ibuprofen had gastro-intestinal side-effects compared with tizanidine/ibuprofen (P = 0.002). This supports previous work in animals showing that tizanidine mediates gastric mucosal protection against anti-inflammatory drugs. More patients given tizanidine/ibuprofen suffered drowsiness and other central nervous system effects (P = 0.025). In patients with severe acute low-back pain, however, some sedation and bed rest is advantageous. This study shows that tizanidine/ibuprofen is more effective in the treatment of moderate or severe acute low-back pain than placebo and ibuprofen alone. Patients (112) with acute low-back pain of recent onset were recruited to this double-blind, randomized, placebo-controlled parallel group study in general practice to evaluate the efficacy and tolerability of the muscle relaxant, tizanidine. They were treated for 7 days with tizanidine (4 mg three times daily) or matching placebo. Aspirin tablets (300 mg) were taken as required as 'rescue' medication. Symptoms were assessed by the patient and doctor before treatment, and after 3 and 7 days. Patients recorded pain and aspirin consumption in a daily diary. Both treatments were effective. In patients who had taken no medication prior to entry, aspirin consumption was almost halved in the first 3 days of taking tizanidine compared with placebo (P = 0.037). Results for pain at rest, pain at night, restriction of movement and pain on movement suggest that tizanidine may give greater improvement, earlier. No serious drug-related adverse events or abnormal biochemistry or haematology were observed in either group. Drowsiness occurred in 22% of patients taking tizanidine although, in patients with severe acute low-back pain, sedation, analgesia and bed rest might be beneficial and desired. Considerably more patients given aspirin/placebo had gastro-intestinal side-effects (P = 0.018). In conclusion, tizanidine may reduce the need for analgesics and be useful in the treatment of acute low-back pain. A new drug, Cyclobenzaprine hydrochloride (Flexeril), was compared with diazepam (Valium) and placebo in double-blind trials for efficacy in treating spasms and pain in the neck and low back. Complex recording methods involving clinical evaluations (graded), patient self-ratings, goniometry, motion analysis by computer, electromyography of controlled motions and detailed statistical analysis were used. Clinical improvement over two weeks was statistically significant in all treatment groups with a statistically significant preference for Cyclobenzaprine hydrochloride. The most striking improvements recorded were in the electromyographic findings, which showed statistically significant changes for the Cyclobenzaprine group. Clinical muscle spasms are not accompanied by increased myoelectric activity; the reverse is true. With improvement, myoelectric activity in back muscles is augmented during prescribed stressful movements as measured by electromyography and computer analysis combined with complex electrogoniometry. nan A double-blind study was carried out to determine the effectiveness of a muscle relaxant, carisoprodol, in the treatment of the low back syndrome, and to test whether this drug would produce any greater effect than an active sedative control. Forty-eight Mexican migrant farm laborers with acute lumbar strain and spasm were given either carisoprodol 350 mg, butabarbital 15 mg, or placebo, four times daily for four days, and then were rated on pertinent symptoms, the degree of limitation of motion (by an objective finger-to-floor test), and overall improvement. In the 43 patients who could be statistically analyzed, carisoprodol was shown to be significantly more effective than butabarbital or placebo in producing improvement of all factors rated. This result suggests that the effects of carisoprodol are not due solely to sedative action, but are also related to its muscle relaxant activity. The efficacy and safety of baclofen (30-80 mg daily) for the treatment of acute low-back syndrome were evaluated in a 14-day, double-blind, randomized study of 200 patients (100 baclofen, 100 placebo). Patients with initially severe or extremely severe symptoms (as opposed to moderate symptoms) benefitted most from treatment with baclofen. The incidence of adverse effects was significantly higher in the baclofen group; however, most were mild to moderate and disappeared in all but two patients who required a reduction in dosage, without reduced drug efficacy. Baclofen was shown to be effective, safe, and well-tolerated for the treatment of patients with acute low-back syndrome. nan The efficacy and safety of oral tolperisone hydrochloride (Mydocalm) in the treatment of painful reflex muscle spasm was assessed in a prospective, randomized, double-blind, placebo-controlled trial. A total of 138 patients, aged between 20 and 75 years, with painful reflex muscle spasm associated with diseases of the spinal column or proximal joints were enrolled in eight rehabilitation centers. Patients were randomized to receive either 300 mg tolperisone hydrochloride or placebo for a period of 21 days. Both treatment groups recovered during the 3 weeks rehabilitation program. However, tolperisone hydrochloride proved to be significantly superior to placebo: the change score of the pressure pain threshold as the primary target parameter significantly increased during therapy with tolperisone hydrochloride (P = 0.03, valid-case-analysis) compared to the results obtained on placebo treatment. The overall assessment of efficacy by the patient also demonstrated significant differences in favor of tolperisone hydrochloride. Best results were seen in patients aged between 40 and 60 years with a history of complaints shorter than 1 year and with concomitant physical therapy. The evaluation of safety data, i.e., adverse events, biochemical and hematological laboratory parameters, demonstrated no differences between tolperisone hydrochloride and placebo. As a conclusion tolperisone hydrochloride represents an effective and safe treatment of painful reflex muscle spasm without the typical side effects of centrally active muscle relaxants. nan 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. Combination therapy was associated with less objective muscle spasm and tenderness and greater motion of the lumbosacral spine (P less than 0.05). 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). nan The myotonolytic activity of a new muscle-relaxant, DS 103-282, was compared with that of diazepam in a randomized double-blind study on thirty patients suffering from acute muscular spasm due to disorders of the cervical and lumbar segments of the spine. Fifteen patients received 5 mg DS 103-282 and fifteen received 5 mg diazepam on a three times daily regime for 7 days. DS 103-282 was found to alleviate symptoms and improve mobility to a significant degree (p less than or equal to 0.05) in all parameters evaluated and was also significantly superior to diazepam in 5 of these. Onset of action was particularly rapid for DS 103-282. Both medications were well tolerated and there was no significant difference between them. On the basis of these data DS 103-282 may be considered a more powerful and faster-acting myotonolytic agent than diazepam with which it was compared in similar clinical indications.
Muscle relaxants are effective in the management of non-specific low back pain, but the adverse effects require that they be used with caution. Trials are needed that evaluate if muscle relaxants are more effective than analgesics or non-steroidal anti-inflammatory drugs.