Primary studies included in this systematic review

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Primary study

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Efficacy and gastroprotective effects of tizanidine plus diclofenac versus placebo plus diclofenac in patients with painful muscle spasms

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Authors Ternelin, S.
Journal Current Therapeutic Research
Year 1998
Links DOI Google Scholar

This article is included in 2 Systematic reviews Systematic reviews (2 references)

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The efficacy and gastroprotective effects of tizanidine plus diclofenac were compared with placebo plus diclofenac in patients with acute local pain syndromes such as low-back pain. This multicenter, double-masked, placebo-controlled, parallel-group study included patients in the Asia-Pacific region who experienced local pain syndromes of recent onset and clinically discernible muscle spasms. Patients received either tizanidine 2 mg twice daily (BID) with diclofenac 50 mg BID or placebo BID with diclofenac 50 mg BID for 7 days. Efficacy variables (pain at rest, at night, on palpation, and during movement; hardness of muscles on palpation; restriction of body movement and disability due to pain; sleep quality; duration of daytime bed rest) and tolerability (includiug a questionnaire for gastrointestinal adverse effects) were assessed at baseline, and on days 4 and 8. Overall efficacy and tolerability were assessed and a test; for occult blood in the stool was performed on day 8. A total of 405 patients were entered into the study in 12 centers in 6 countries; 361 were assessable. Results revealed that the combination of tizanidine with diclofenac was significantly more effective than diclofenac with placebo for most variables. Overall tolerability was better in patients who received tizanidine with diclofenac, although the difference between groups did not reach statistical significance. However, the frequency of gastrointestinal adverse effects was significantly less in patients who received tizanidine plus diclofenac (12%) compared with patients who received placebo plus diclofenac (32%). The frequency of positive test results for occult blood in the stool was 5% in the former group and 11% in the latter group. The combination of tizanidine with diclofenac was more effective and better tolerated than diclofenac alone in patients with local pain syndromes. This study confirms and extends the results of previous studies suggesting increased efficacy and gastroprotective effects of tizanidine when combined with nonsteroidal anti-inflammatory drugs.

Primary study

Unclassified

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.

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Authors Pratzel HG , Alken RG , Ramm S
Journal Pain
Year 1997
Links Pubmed DOI

This article is included in 2 Systematic reviews Systematic reviews (2 references) 1 Broad synthesis Broad syntheses (1 reference)

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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.

Primary study

Unclassified

[Flupirtine in comparison with chlormezanone in chronic musculoskeletal back pain. Results of a multicenter randomized double-blind study].

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Journal Fortschritte der Medizin
Year 1997
Links Pubmed

This article is included in 2 Systematic reviews Systematic reviews (2 references)

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METHOD: The analgesic and muscle-relaxing properties of flupirtine maleate, chlormezanone and placebo were compared in a total of 184 patients. Of these patients, 164 met the criteria of the treatment plan (intention to treat), and the data of 140 patients were finally evaluated in accordance with the test protocol. A positive response was defined as a reduction in pain intensity and muscle tension by 2 categories on the 5-category verbal scale "very severe/severe/moderate/mild/ none" on the seventh day of treatment. RESULTS: In the per-protocol-analysis the responder rate was 60.9% for flupirtine, 47.8% for chlormezanone, and 43.8% for placebo, the difference between drugs and placebo not being significant. The overall assessment of the physicians involved was very good/ good in 47.8% and satisfactory in 37.0% of the flupirtine group, very good/good in 45.6% and satisfactory in 17.4% of the chlormezanone group, the corresponding figures for the placebo group being 33.4% and 20.6%, respectively. Flupirtine was thus superior to placebo (p = 0.007). The incidence of adverse drug reactions was 14.8% (8/54) for flupirtine, 19.3% (11/57) for chlormezanone, and 7.3% (4/55) for placebo.

Primary study

Unclassified

Cyclobenzaprine and naproxen versus naproxen alone in the treatment of acute low back pain and muscle spasm.

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Journal Clinical therapeutics
Year 1990
Links Pubmed

This article is included in 4 Systematic reviews Systematic reviews (4 references)

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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).

Primary study

Unclassified

Mefenamic acid, chlormezanone-paracetamol, ethoheptazine-aspirin-meprobamate: a comparative study in acute low back pain.

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Authors Sweetman BJ , Baig A , Parsons DL
Journal The British journal of clinical practice
Year 1988
Links Pubmed

This article is included in 5 Systematic reviews Systematic reviews (5 references)

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Primary study

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Tizanidine and ibuprofen in acute low-back pain: results of a double-blind multicentre study in general practice.

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Authors Berry H , Hutchinson DR
Journal The Journal of international medical research
Year 1988
Links Pubmed DOI

This article is included in 6 Systematic reviews Systematic reviews (6 references)

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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.

Primary study

Unclassified

A multicentre placebo-controlled study in general practice to evaluate the efficacy and safety of tizanidine in acute low-back pain.

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Authors Berry H , Hutchinson DR
Journal The Journal of international medical research
Year 1988
Links Pubmed DOI

This article is included in 4 Systematic reviews Systematic reviews (4 references)

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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.

Primary study

Unclassified

Acute low back pain: symptomatic treatment with a muscle relaxant drug

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Authors Casale, R.
Journal The Clinical journal of pain
Year 1988

This article is included in 2 Systematic reviews Systematic reviews (2 references)

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The aim of this work was to evaluate in a double-blind controlled study the effect of a pure muscle relaxant drug (dantrolene sodium) in the symptomatic treatment of uncomplicated acute low back pain in 20 patients. The one capsule daily dosage (25 mg) was given for 4 days. Patients treated with dantrolene sodium obtained an improvement of muscle contracture (p < 0.001 versus placebo). VAS pain measurement, and pain behavior (both p < 0.001 versus placebo). The electromyogram (EMG) parameters (i.e., the antalgic reflex motor unit firing) improved in the treated group (p < 0.01 versus placebo). Data show the possibility of treating uncomplicated acute low back pain with a pure muscle relaxant. Some basic physiopathological aspects of low back pain are also discussed.

Primary study

Unclassified

Baclofen for the treatment of acute low-back syndrome. A double-blind comparison with placebo.

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Journal Spine
Year 1985
Links Pubmed DOI

This article is included in 3 Systematic reviews Systematic reviews (3 references)

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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.

Primary study

Unclassified

A new skeletal muscle relaxant (DS 103-282) compared to diazepam in the treatment of muscle spasm of local origin.

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Authors Hennies OL
Journal The Journal of international medical research
Year 1981
Links Pubmed DOI

This article is included in 2 Systematic reviews Systematic reviews (2 references)

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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.