Atroshi 2006.
| Methods | Single centre RCT | |
| Participants | Of the 128 participants who had participated in the previous randomised trial, 2 died and the other 126 (63 participants in the OCTR group and 63 participants in the ECTR group) took part in this 5‐year extended follow‐up Women: 65 (52 OCTR, 44 ECTR), mean age 44 (range 25 to 59) years Men: 32 (13 OCTR, 19 ECTR), mean age 44 (range 26 to 59) years Eligibility criteria: 1. primary idiopathic CTS; 2. between 25 and 60 years of age; 3. employed; 4. with symptoms of classic or probable CTS according to the diagnostic criteria in the Katz hand diagram; 5. nerve conduction test shows median neuropathy at the wrist (distal motor latency of 4.5 ms, wrist‐digit sensory latency of 3.5 ms, or sensory conduction velocity at the carpal tunnel segment of 40 m/s) but no other abnormalities; 6. symptom duration of at least 3 months; and 7. inadequate response to 6‐weeks' treatment by wrist splint. People with CTR in the contralateral hand were excluded |
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| Interventions | 2‐portal ECTR (extrabursal) vs OCTR | |
| Outcomes | Follow‐up at 3 and 6 weeks, 3 months, 1 year (Atroshi 2006) and 5 years (Atroshi 2009) SSS, FSS, severity of pain in the scar or proximal palm, satisfaction (completely satisfied, very satisfied, rather satisfied, or dissatisfied) |
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| Notes | The 5‐year follow‐up is presented by Atroshi 2006. Atroshi 2009 is the longer follow up of Atroshi 2006 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | A computer generated randomisation list in blocks of 8 was used |
| Allocation concealment (selection bias) | Low risk | The participants were assigned to a treatment group in the operating room immediately before surgery, according to a computer generated randomisation list. In the operating room the surgeon opened the lowest numbered of sequentially numbered sealed opaque envelopes containing the group assignment |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No information given. Participants and personnel could not be blinded |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | In Atroshi 2006, the authors say "Before each postoperative examination, the patients were instructed not to discuss the type of operation and had their palm and distal forearm covered with a stockinette (an elastic, sleeve‐like dressing) concealing the scars. The assessor was thus blinded to the surgical method." However, most of the outcomes were self assessed by the patients and participants were not blinded. There was no reference to blinding in the 5‐year follow‐up report (Atroshi 2009) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | ITT analysis performed (2 OCTR participants died for other reasons and 1 ECTR was converted to OCTR) |
| Selective reporting (reporting bias) | Low risk | All data were reported as prespecified in the protocol. However, not all outcomes assessed in Atroshi 2006 were also assessed in the 5‐year follow‐up |
| Other bias | Low risk | No baseline differences This study was supported by research grants from Skane County Council’s Research and Development Foundation, Kristianstad University, and The Swedish Society of Medicine The authors declared no conflict of interest |