Zarezadeh 2012.
Methods | RCT | |
Participants | 48 participants were enrolled in the study (age range 25 to 60 years; 27 male, 21 female) with clinical and neurophysiological evidence of ulnar nerve impairment at the elbow. The trial authors declare: "according to clinical and paraclinical tests, severe and moderate patients and mild group that did not respond to conservative treatment were operated"; however, they do not indicate how the severity was defined. Exclusion criteria included deformity or distortion of the cubital tunnel due to previous trauma to the elbow and recurrent cubital tunnel syndrome after previous surgery. | |
Interventions | Anterior subcutaneous transposition (24 participants), anterior submuscular transposition (24 participants) | |
Outcomes | Clinical outcomes:
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Conflicts of interest | None declared. | |
Study funding | None | |
Notes | Operations performed between October 2008 and March 2009. Single centre, Iran. Electrophysiological evaluation was performed before and 12 months after surgery, but no data are available. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "based on a random table numbers, generated by the random allocation software, the principal investigator allocated patients into two groups" |
Allocation concealment (selection bias) | Unclear risk | Quote: "based on a random table numbers, generated by the random allocation software, the principal investigator allocated patients into two groups" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "To prevent bias, all patients underwent double‐blind nerve conduction velocity studies, conducted by two neurophysiologists according to a standard protocol, before and after surgery". Comment: Despite this quote, the authors do not unequivocally state that the participants were blinded to the treatment. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "To prevent bias, all patients underwent double‐blind nerve conduction velocity studies". Comment: It is not specified if the clinical outcomes were assessed by a blinded examiner. |
Incomplete outcome data (attrition bias) Clinical or neurophysiological outcome | Low risk | No participant was lost to follow‐up. |
Selective reporting (reporting bias) | High risk | No neurophysiological data are available. |
Other bias | High risk | The sample size was not calculated. The trial authors do not specify if the study was designed to be a non‐inferiority or a superiority trial. |
MRC: Medical Research Council RCT: randomised controlled trial SD: standard deviation UNE: ulnar neuropathy at the elbow VAS: visual analogue scale