Mishra 2006.
| Methods | Randomised controlled trial No blinding 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 = 40 (71 wrists) randomised and completed Intervention group N = 20 (36 wrists) randomised and completed Control group N = 20 (35 wrists) randomised and completed 7 males, 33 females Mean ± SD (range) age: Intervention group 1: 42.19 ± 9.39 (23 to 60) yrs Control group 2: 41.57 ± 9.26 (28 to 60) yrs Mean ± SD duration of CTS symptoms: Intervention group 1: 6.40 ± 7.09 months Control group 2: 6.31 ± 7.50 months Inclusion criteria: 1. Symptoms suggestive of CTS of at least 1‐month duration and electrophysiological evidence of median neuropathy at wrist Exclusion criteria: 1. Diabetes mellitus, trauma to wrist and deformity 2. Evidence of generalised neuropathy / radiculopathy on electrodiagnostic study 3. Advanced CTS having wasting, marked weakness with marked axonal loss on nerve conduction study or nonstimulatable nerves 4. History of peptic ulcer 5. Previous treatment for CTS using medical or surgical therapy 6. Pregnancy 7. Systemic disorders like rheumatoid arthritis, hypothyroidism, amyloidosis, etc |
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| Interventions | Intervention: Commercially available carpal tunnel splint worn in the neutral position at night and as much as possible during the daytime for 4 weeks. In the case of bilateral symptoms, both hands were treated. Participants were also told not use additional medicines or other methods of treatment during the study period. Advice to avoid extremes of wrist flexion or extension, excessive hand movement and hand rest was provided. Control: Oral prednisolone 20 mg/day was taken for 2 weeks followed by 10 mg/day for another 2 weeks. Advice to avoid extremes of wrist flexion or extension, excessive hand movement and hand rest was provided. |
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| Outcomes | Outcomes assessed before treatment and at the end of four weeks of treatment and at eight weeks post‐treatment: 1. Symptoms using carpal tunnel questionnaire (rates 11 items on ordinal scale 1: no symptoms, to 5: very severe symptoms) 2. Hand function using carpal tunnel questionnaire (rates 8 items on ordinal scale 1: no difficulty, to 5: very severe symptoms preventing the activity) 3. Nerve conduction: median nerve motor distal latency (msec), median nerve motor conduction velocity (metres/second), median nerve sensory distal latency (msec), median nerve sensory conduction velocity (metres/second) 4. Adverse effects: measured as the number of participants experiencing adverse effects (e.g., discomfort and swelling of the hands and wrist) |
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| Notes | The results of all outcomes were reported as both endpoint and change from baseline values. There were no differences between endpoint and change from baseline values in terms of statistical significance, so 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 confirmed (via personal communication) that the correlation between both wrists was not accounted for in the analysis. Therefore, a unit of analysis error occurred. Attempts to obtain the individual participant and wrist outcome data from the trialists were unsuccessful. 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) | Low risk | Quote: "Randomization was done using the table of random numbers." Comment: The randomisation sequence was probably adequately generated. |
| Allocation concealment (selection bias) | Unclear risk | Quote: "All patients were randomly allocated to one of the following two groups: 1. Splinting in neutral position. 2. Oral steroid. Randomization was done using the table of random numbers." Comment: Not enough information to determine whether the treatment allocation was adequately concealed until interventions were assigned. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "A prospective randomised open‐label clinical and electrophysiological study of efficacy of splinting and oral steroids for the treatment of CTS was done." Comment: Participants were probably aware of which intervention they received. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: Authors did not report any information on blinding of treatment allocation, so there is not enough information to determine whether outcome assessors were blind or not. |
| Incomplete outcome data (attrition bias) 3 months or less | Low risk | Comment: No withdrawals, drop‐outs or losses to follow‐up were reported, and the authors indicated in the results tables that data was based on all 71 randomised wrists. |
| Selective reporting (reporting bias) | Low risk | Comment: All of the study's outcomes (pre‐specified in the Methods section of the study report) were reported in the pre‐specified way. |
| Other bias | Low risk | Comment: No other sources of bias identified. |