Nabhan 2005.
Methods | RCT | |
Participants | 66 people (mean age 52 years, SD 12; 38 males, 28 females) with clinical and electrophysiological evidence of ulnar nerve neuropathy Exclusion criteria: previous traumas to the elbow causing deformity or distortion of the cubital tunnel, as well as recurrent cubital tunnel syndrome after previous surgery |
|
Interventions | Simple decompression (32 participants), decompression and anterior subcutaneous transposition (34 participants) | |
Outcomes | Clinical outcomes:
Electrophysiological outcome: motor nerve conduction velocity |
|
Conflicts of interest | No information provided. | |
Study funding | No information provided. | |
Notes | Operations performed between August 2001 and October 2003. Single centre in Germany. Follow‐up examinations at 3 and 9 months after surgery. The sample size was not calculated. Only people with severe disease were included in the study. The authors do not specify if the study was designed to be a non‐inferiority or a superiority trial. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomisation was carried out by drawing cards in sealed envelopes" |
Allocation concealment (selection bias) | Low risk | Quote: "Randomisation was carried out by drawing cards in sealed envelopes" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not specified. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "All patients underwent nerve conduction velocity studies pre‐operatively by two blinded neurophysiologists according to a standard protocol" Comment: It is not specified if the postoperative evaluation was performed by blinded examiners. |
Incomplete outcome data (attrition bias) Clinical or neurophysiological outcome | Low risk | No participant lost to follow‐up. |
Selective reporting (reporting bias) | Low risk | Results from all the outcome measures are reported. |
Other bias | High risk | The outcome measures used to evaluate clinical improvement in terms of sensation and motor strength may have a low sensitivity. The sample size was not calculated. The authors do not specify if the study was designed to be a non‐inferiority or a superiority trial. |