Summary of clinical trials of ibuprofen in the treatment of backache
This is a selection of clinical trials representative of the published work for this indication.
1. The topical NSAID, felbinac, versus oral ibuprofen
Study design
Ibuprofen 400 mg three times daily was compared with topical felbinac (an NSAID) in 261 evaluable patients with acute lower back injury for up to 2 weeks. Patients with sciatica, prior injury or a history of 2 or more episodes of back pain, were excluded.
This study was:
randomised
double-blind
Summary of results
After 1 and 2 weeks both treatments significantly reduced the severity of spontaneous pain, pain on movement, restriction of movement, muscle spasm and tenderness. The overall efficacy of treatment was fair to excellent in 90% of those taking ibuprofen and in 92% of patients using felbinac. The median number of days to resumption of normal activities was 6 for ibuprofen and 7 for felbinac. Overall tolerability was fair to excellent in 94% and 97% respectively. Stated patient preferences favoured ibuprofen in 32% of patients and felbinac in 37%; 31% had no preference. Both treatments were well tolerated.
Reference
Hosie GAC. The topical NSAID, felbinac, versus oral ibuprofen; a comparison of efficacy in the treatment of acute lower back injury. Br J Clin Res 1993;4:5-17
2. Tizanidine and ibuprofen in acute low back pain
Study Design
Ibuprofen 400 mg three times daily (plus either placebo or tizanidine, a muscle relaxant) was evaluated in 105 patients with acute low back pain of moderate severity and movement limitation. The duration of treatment was 7 days. Assessments were made at baseline, 3 and 7 days.
This study was:
randomised
double-blind
Summary of results
Considering only the 54 patients treated with ibuprofen/placebo: compared with baseline, ibuprofen significantly reduced pain at night, pain at rest and pain during movement after 3 and 7 days. It also improved pain due to sciatica and reduced movement restriction in 60% of patients after 3 days and in 80% after 7 days. After 7 days, 75% of patients reported that treatment with ibuprofen had helped and the investigators considered that 81% of patients had improved. Treatment was well tolerated in 94% of patients, with 20% reporting gastrointestinal symptoms.
Reference
Berry H, Hutchinson DR. Tizanidine and ibuprofen in acute low back pain: results of a double-blind multicentre study in general practice. J Int Med Res 1988;16:83-91
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