| Methods |
Randomised, parallel group trial
Randomisation by alternation
Blinding not possible |
| Participants |
57 leprosy patients with complaints suggestive of ulnar nerve dysfunction < 24 weeks duration
Unit of randomisation: person
Unit of analysis: ulnar nerve
Persons randomised: 57 with 75 ulnar nerves (18 bilateral cases)
Nerves analysed: 62 of 44 persons (a: 31, b: 31) |
| Interventions |
a) Prednisolone 30 mg/day for 1 week, reducing the daily dose by 5 mg every week for 6 weeks (total 735 mg)
(b) Same intervention plus external nerve decompression and a simple, subperiosteal medial epicondylectomy |
| Outcomes |
Change in:
(1) Sensory score after 1 year
(2) VMT score after 1 year
(3) Nerve pain and tenderness after 1 year
(4) Stretch test |
| Notes |
Single centre
Conducted in India |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
High risk |
Alternation |
| Allocation concealment (selection bias) |
High risk |
Alternation |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
Blinding of patients and clinicians not possible; blinding of outcome assessor not reported |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
13/75 (17%) loss to follow‐up of nerves, 13/57 participants (23%); no intention‐to‐treat analysis was performed. |
| Selective reporting (reporting bias) |
High risk |
The occurrence of adverse effects was not reported |
| Other bias |
High risk |
No separate analysis was done using only one independent outcome from each patient |
