| Methods |
Randomised controlled trial.
Blinding: Outcome assessment was blinded. Unclear if patients were blinded.
Loss to follow‐up: none reported
Appropriate statistical analysis: Yes, appears to be intention to treat analysis. |
| Participants |
47 patients.
Inclusion criteria: capsulitis of the shoulder defined by abduction and forward flexion of less than 90 degrees, external rotation less than 20 degrees, an intact rotator cuff clinically and normal shoulder radiographs |
| Interventions |
Group 1(14 patients): shoulder distension with air (6ml 0.25% bupivacaine + 3ml air = 9ml total)
Group 2 (15 patients): intra‐articular steroid injection (40mg triamcinolone acetonide in 1ml injection)
Group 3 (18 patients): distension with air and steroid (40mg triamcinolone acetonide in 1ml + 6ml 0.25% bupivacaine + 3ml air = 10ml total) |
| Outcomes |
Assessment at baseline, 6, 12 and 16 weeks.
1) Analgesic use
2) severity of pain in relation to daily activities (on a 6‐point scale from 0=none to 5 = severe, interferes with sleep)
3) severity of pain with resisted shoulder movement (on a 4‐point scale from 0 = none to 3 = severe, with pain inhibition)
4) range of active and passive abduction and forward flexion using a hydrogoniometer and external rotation of the shoulder according to Cyriax method
5) strength using a isokinetic shoulder dynanometer |
| Notes |
Improvement in symptoms (pain was not reported separately by treatment group.
See analyses 7 for comparison of improvement in range of movement by treatment group.
Comparison of distension with air plus steroid versus steroid injection alone is included in the hydrodilatation review. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
