Eraslan 2014.
Study characteristics | ||
Methods |
Study design: 2‐arm quasi‐randomised trial Setting: unclear |
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Participants |
Details of sampling frame: Total n eligible = not reported Total n excluded pre‐randomisation = not reported Total n randomised = 30 participants (47 wrists) Total n available for follow‐up = 30 Total n analysed = 30 Intervention group 1 (splint) n = 15 Intervention group 2 rigid taping) = 15 Gender distribution Intervention group 1 (splint): 2 male, 13 females Intervention group 2 (rigid taping): 2 male, 13 females Mean ± SD (range) age: Intervention group 1 (splint): 43.5 ± 13 Intervention group 2 (rigid taping): 48.9 ± 12 Total mean: 46.2 (aged between 21 and 71 years) Mean ± SD (range) duration of symptoms, months Not reported Inclusion criteria: CTS according to the electroneuromyography (ENMG) and American Association of Electrodiagnostic Medicine criteria Exclusion criteria:
CTS diagnostic criteria (case definition): Not reported CTS severity: Not reported Protocol violators: None |
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Interventions | Group 1 ‐ splint: On the 6th day of the treatment, participants were recommended night splint without thumb support. While allowing pronation and supination of the wrist, a neutral positioned splint with volar support was used, which would not allow flexion, extension and deviation. The participants were advised to use their splints for an average of 8 hours each night. Group 2 ‐ rigid taping: Rigid taping was applied by stretching the carpometacarpal joint with the anchor tie around the thumb, relaxing the flexor retinaculum, and finally stretching the metacarpophalangeal joint and closing it with the last anchor tie on the thumb. Both groups: physical therapy programme consisting of 21 sessions of hot application‐ultrasound‐TENS. Hot application for 20 minutes, ultrasound for 4 minutes (1.5 W/cm2 for 2 minutes in each hand), and 20 minutes of TENS (continuous mode) were applied once a day, 6 sessions a week. In the first 6 days of treatment, the participants were recommended to restrict excessive hand and wrist activities. On the 6th day of the treatment, both groups were given tendon shifting, median nerve shifting, strengthening exercises for the wrist, strengthening exercises for the intrinsic muscles, especially strengthening and stretching exercises for the thumb (abductor pollicis muscle) and median nerve stretching. |
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Outcomes | Outcomes were collected at baseline and at the 21st day of the treatment
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Funding | Not reported | |
COI | Not reported | |
Notes | Article in Turkish, translation used Results from BCTQ not reported in scale 1 to 5. We assumed that total sum was reported and divided symptom score by 11 and functional score by 8 (as per instructions of the scale). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quote from translation: "Patients were allocated to two treatment groups as night splint and rigid taping. The first patient assigned to a group according to the coin toss method. The following patients were grouped considering the arrival order." Comment: Only the first participant was randomised and the rest were sequentially allocated, which is not true randomisation. |
Allocation concealment (selection bias) | High risk | Quote from translation: "Patients were allocated to two treatment groups as night splint and rigid taping. The first patient assigned to a group according to the coin toss method. The following patients were grouped considering the arrival order." Comment: No true randomisation and the sequence was not concealed from the investigators. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: Not reported, but due to the nature of the interventions (splint versus taping), it is likely that participants were aware of their allocated treatment. |
Incomplete outcome data (attrition bias) 3 months or less | Low risk | Comment: Data given for all participants in the table |
Selective reporting (reporting bias) | Unclear risk | Comment: No protocol available to confirm the planned outcomes, therefore the risk was unclear. BCTQ reported fully for both groups |
Other bias | Low risk | Comment: 1) The BCTQ scores were reported in a modified way. The standard method is to divide by the number of questions (scale 1 to 5) but the authors reported the total score (scale probably 19 to 95). However, this did not cause bias because both groups were reported similarly. 2) The level of analysis was the participant, therefore clustering should not affect the analysis. |