Goldie 1968a.
Methods | RCT; double‐blind, placebo‐controlled trial | |
Participants | 50 inpatients and 5 outpatients with true sciatica, low back pain with irradiation down either leg were included. Duration of symptoms did not exceed 3 weeks | |
Interventions | Treatment duration 16 days, follow‐up duration 7 and 14 days (i) NSAID group: indomethacin 25 mg 3 times daily (n = 25) (ii) Control group: placebo 3 times daily in identical capsules (n = 25) No other drugs and no physical therapy allowed during the treatment duration |
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Outcomes | Pain: Daily registration of pain, results not reported. Disability: Not assessed. Clinical tests including straight leg raise test were performed daily. No difference between the groups at 7 and 15 days. Global improvement: Relief in pain intensity using a scoring system: no recovery from initial pain (3 points), lessened pain (= fair relief, 2 points), no pain (= complete pain relief, 1 point). At day 7, 15 out of 25 participants in the NSAID group and 18 out of 25 in the placebo group reported a fair or complete relief of pain. After 14 days, 15 in the NSAID group and 18 in the placebo group reported fair or complete relief. Additional drug use: No additional drug use allowed. Other outcomes: None. Adverse effects: Adverse effects were reported in 13/50 participants: headache (NSAID group n = 4, placebo n = 2), nausea (NSAID group n = 4, placebo n = 2), dizziness (NSAID group n = 0, placebo n = 1) |
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Notes | Did not report on funding | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information given on how the random sequence was generated |
Allocation concealment (selection bias) | Low risk | Only the manufacturer of the indomethacin and the identical placebo capsules knew the code |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Doctors, nurses, and participants were unaware of the treatment |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Doctors, nurses, and participants were unaware of the treatment |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No reporting on missing data and ITT analysis |
Selective reporting (reporting bias) | Low risk | The outcomes defined in the methods section were reported in the results. No protocol published |
Group similarity at baseline | Unclear risk | Only limited information on baseline characteristics reported |
Influence of co‐interventions | Low risk | No additional treatment during the intervention |
Compliance with interventions | Unclear risk | Not addressed |
Funding | Unclear risk | Not reported |
Other bias | High risk | Small trial. The scale used for the outcome only allowed answers for the following responses: lessened pain, no pain, pain relief, therefore no deterioration could be reported |