Svernlov 2009.
Methods | RCT | |
Participants | 70 people (age range 17 to 72 years; 31 male, 39 female) with clinical mild or moderate ulnar neuropathy at the elbow classified with the Dellon’s staging system. 12 participants only had abnormal findings at the electrophysiological evaluation. Exclusion criteria: "Patients with past or present symptoms of neck problems, clinical signs of another nerve problem, previous trauma or surgery to the same arm, arthritis or palpable swelling at the elbow or subluxations of the ulnar nerve" | |
Interventions |
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Outcomes | Clinical outcome:
Electrophysiological outcome (preoperatively performed in all participants, postoperatively in 45 participants): ulnar motor and sensory nerve conduction studies, electromyography Participants assessed their symptoms according to the Canadian Occupational Performance Measure (COPM). |
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Conflicts of interest | No information provided. | |
Study funding | No information provided. | |
Notes | Performed between March 1997 and December 2000. Follow‐up at 6 months after surgery. 2 centres, Denmark and Sweden | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of sequence generation is not clearly described. |
Allocation concealment (selection bias) | Low risk | Quote: "patients were then randomised using sequentially numbered, sealed envelopes into three groups for different treatments" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were not blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Another, independent, occupational therapist at each centre evaluated the patients before and 6 months after starting the study" |
Incomplete outcome data (attrition bias) Clinical or neurophysiological outcome | Low risk | Quote: "Thirteen patients ... in the primarily randomized patients completed the programme but were unavailable for the follow‐up at 6 months. Six did not attend because of practical or personal reasons and seven had developed other symptoms (such as carpal tunnel syndrome, epicondylalgia, impingement syndrome or neck pain). Another six patients, two from each group, underwent surgical decompression because of persistent symptoms" |
Selective reporting (reporting bias) | Low risk | Results from all the outcome measures are reported. |
Other bias | Unclear risk | 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. Only 24% of participants had neurophysiological evidence of UNE. |