Bush 1991.
Methods | Placebo‐controlled trial Source: hospital rheumatology department Country: UK |
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Participants | 23 patients randomised (Group 1 = 12, Group 2 = 11); Diagnosis: clinical assessment Mean age (SD): Group 1 = 38.2 years (13.4), Group 2 = 37.3 years (8.0); Duration of symptoms: acute (< 1 month) |
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Interventions | Group 1: epidural injection of 25 mL containing triamcinolone acetonide (80 mg) plus procaine hydrochloride (0.5%) plus saline Group 2: epidural injection of saline (25 mL) | |
Outcomes |
Pain intensity: overall pain (VAS); Adverse events: proportion of patients experiencing adverse events Follow‐ups: 4 and 52 weeks |
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Notes |
Epidural approach: caudal without the use of imaging guidance. Patients received 2 injections: first at admission to the trial and a second after 2 weeks. Anaesthetist's experience: not specified Co‐interventions: additional analgesics allowed. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "… the patients were randomised to receive either active or placebo treatment." |
Allocation concealment (selection bias) | Unclear risk | Not mentioned. |
Blinding of participants (performance bias) | Low risk | Patients were blinded to the interventions (placebo‐controlled trial using epidural approach). |
Blinding of personnel/care providers (performance bias) All outcomes | High risk | The procedures are clearly different which confirm that the care providers were not blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Self‐report outcomes with patients blinded to the treatment allocation. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 23 out of 28 (82%) completed the short‐term and long‐term follow‐up. Loss to follow‐up at short‐term and long‐term follow‐up were below the proposed threshold. |
Intention‐to‐treat analysis (attrition bias) | Unclear risk | Not mentioned. |
Selective reporting (reporting bias) | Unclear risk | The protocol of the trial was not registered by the authors. |
Group similarity at baseline (selection bias) | High risk | "Statistical difference between the two groups in SLR ability". |
Co‐interventions (performance bias) | Low risk | "Additional measures in the form of bed rest analgesics corsets and manipulation were allowed, only analgesics were permitted in the first four weeks." |
Compliance (performance bias) | Low risk | Compliance in both groups 100%. |
Timing of outcome assessment (detection bias) | Low risk | "Assessments were made at baseline 4 weeks and 1 year". |
Other bias | Unclear risk | Funding and conflict of interest were not reported. |