Walker 2000.
| Methods | Quasi‐randomised controlled trial No blinding reported Ethics approval and informed consent obtained Randomisation occurred at the level of participants, where participants with bilateral CTS received the same intervention for both affected wrists. |
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| Participants | Total N = 21 (30 wrists) randomised; 17 participants (24 wrists) completed
Group 1* N = 11 wrists completed
Group 2* N = 13 wrists completed 20 males; 1 female Mean ± SD age: Group 1: 60 ± 9 yrs Group 2: 61 ± 13 yrs Inclusion criteria: 1. Clinical diagnosis of CTS confirmed with electrodiagnostic studies 2. No previous treatment for CTS |
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| Interventions | Group 1: Full time wear of wrist splint for 6 weeks Group 2: Nighttime only wear of wrist splint for 6 weeks |
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| Outcomes | Outcome assessed at the end of six weeks of treatment: 1. Symptoms using carpal tunnel questionnaire (rates 11 items on ordinal scale 1 to 5, where 1 = mildest pain, 5 = most severe pain) 2. Hand function using carpal tunnel questionnaire (rates 8 items on ordinal scale 1 to 5, where 1 = no difficulty with activity, 5 = cannot perform activity at all) 3. Nerve conduction: median motor and sensory distal latencies (in ms) 4. Compliance (using questionnaire asking whether participants "always/usually wore", "sometimes wore" or "rarely/never wore" splint) 5. NSAID use |
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| Notes | *Data only reported for participants completing treatment (n = 17 participants, 24 hands) The results of all outcomes were reported as both endpoint and change from baseline values. There were some differences between endpoint and change from baseline values in terms of statistical significance, though to minimise selective inclusion bias, we chose to be consistent and only include endpoint values (as we included endpoint values where available for all other studies included in the review). Analysis was undertaken at the wrist‐level for all outcomes, though some participants in each group had bilateral CTS. Bilateral cases had the same intervention applied to each wrist. The trialists did not report how the correlation between both wrists was accounted for in the analysis, and attempts to clarify this information from the trialists were unsuccessful. Therefore, it is not clear whether a unit of analysis error occurred. No attempt was made to adjust outcome data. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Quote: "The randomization protocol was based on the last digit of the subject's Social Security number.." Comment: Allocation sequence was not truly random. |
| Allocation concealment (selection bias) | High risk | Comment: The last digit of the participant's Social Security number was used, therefore allocation was not concealed. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: The authors describe the trial as "unblinded". Participants were not blinded to splint‐wearing. Self‐administered questionnaires for the symptom severity scale, functional status scale, and splint‐wearing compliance for the last two weeks of the trial may have been influenced by the participant's knowledge of their own splint‐wearing behaviour. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "All electrodiagnostic testing was performed by or under the direct supervision of the principle investigator". Comment: Nerve conduction studies were not assessed blindly (personal communication with author). |
| Incomplete outcome data (attrition bias) 3 months or less | Low risk | Quote: "Subjects were informed that steroid injections and surgery were also treatment options for CTS, and participation in this study did not prohibit them from seeking additional treatment, but they would be dropped from the study if they did so". Comment: One participant from each group was excluded because they had surgery or steroid injections. Losses from each group were balanced (two participants from each group) and unlikely to be a source of bias. |
| Selective reporting (reporting bias) | Low risk | Comment: All measures appear to be reported as described in the protocol of the trial publication. |
| Other bias | Low risk | Quote: "..subjects with bilateral involvement always received the same instructions for both hands...measures were taken for each hand". Comment: Participants were allocated to treatment groups (not hands) therefore those with bilateral involvement each contributed two hands to the analysis. The number of bilateral cases were similar in both treatment groups, so a unit‐of analysis error is unlikely to have occurred. |