Oncu 2014.
Study characteristics | ||
Methods | Study design: RCT, blind assessor Setting: physical therapy outpatient clinic, Turkey |
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Participants |
Details of sampling frame: Total n eligible = not reported Total n excluded pre‐randomisation = not reported Total n randomised = 40 participants (60 wrists) Total n available for follow‐up = 40 participants (60 wrists) Total n analysed = 40 participants (60 wrists) Intervention group 1 (splint + exercise) n = 15 wrists Intervention group 2 (kinesiology tape + exercise) n = 15 wrists Intervention group 3 (kinesiology tape + splint + exercise) n = 15 wrists Intervention group 4 (exercise) n = 15 wrists Gender distribution: Intervention group 1 (splint + exercise): not reported Intervention group 2 (kinesiology tape + exercise): not reported Intervention group 3 (kinesiology tape + splint + exercise): not reported Intervention group 4 (exercise): not reported Total: 40 females, 0 males Mean ± SD (range) age: Intervention group 1 (splint + exercise): not reported Intervention group 2 (kinesiology tape + exercise): not reported Intervention group 3 (kinesiology tape + splint + exercise): not reported Intervention group 4 (exercise): not reported Total: 48.97+10.66 Mean ± SD (range) duration of CTS symptoms: Intervention group 1 (splint + exercise): not reported Intervention group 2 (kinesiology tape + exercise): not reported Intervention group 3 (kinesio tape + splint + exercise): not reported Intervention group 4 (exercise): not reported Inclusion criteria:
Exclusion criteria:
CTS diagnostic criteria (case definition):
CTS severity: Mild‐to‐moderate |
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Interventions | Group 1 ‐splint and exercise (tendon and nerve gliding exercises for 25 days): Participants received a splint in a neutral position with a volar support which allowed wrist pronation and supination while extension and deviation were restricted. Participants were recommended to use the splint at night for 25 days. Group 2 ‐kinesiology taping and exercise (tendon and nerve gliding exercises for 25 days): kinesiology taping was performed using neural technique and ligament technique/space correction techniques. which are recommended for CTS. Group 3 ‐ kinesiology taping (see above) and splint (see above) and exercise (tendon and nerve gliding exercises for 25 days) Group 4 ‐ exercise only: (tendon and nerve gliding exercises for 25 days) |
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Outcomes | Outcomes assessed at 25 days post‐randomisation, and 2 and 3 months follow‐up
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Funding | The authors declared that this study has received no financial support. | |
COI | No conflict of interest was declared by the authors. | |
Notes | Article in Turkish, translation used BCTQ results reported as mean from 1 to 5 (higher is worse) in the article, table 1 and 2 Results for BCTQ functional status score provided for 3 months only (not for 25 days and 2 months) The authors reported that 10 of 40 participants had bilateral CTS, however the total number of wrists in the study were 60 (not 50). We used 40 as the number of participants (60 wrists) in the analysis. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote from translation: "Four different treatment alternatives were created via computer by a statistical expert and the same person enumerated from high to low in an order and put them into envelopes. 40 patients were assigned to 4 groups according to the sequential (ranking) randomization method. The person who performs the therapy opened the envelope and carried out the treatment method from the envelope regarding the number of the patient." |
Allocation concealment (selection bias) | Low risk | Quote from translation: "Four different treatment alternatives were created via computer by a statistical expert and the same person enumerated from high to low in an order and put them into envelopes. 40 patients were assigned to 4 groups according to the sequential (ranking) randomization method. The person who performs the therapy opened the envelope and carried out the treatment method from the envelope regarding the number of the patient." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: Study was single (observer)‐blind. Given the nature of the assigned interventions, participants were not blind. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote from translation: "One and same blind observer filled the assessment forms of all patients included in the study before, at 25th day (end of the study) and 2 and 3 months after the study. All patients were evaluated by ENMG by the same and blind (for the treatment) observer before and 3 months after the study in the same ENGM laboratory." Comment: Since participants themselves assessed participant‐reported outcomes and they were likely to be aware of their allocated treatment in this study, we rated the risk as high. |
Incomplete outcome data (attrition bias) 3 months or less | Low risk | Comment: No dropouts reported, and data reported as being based on all wrists that were randomised (n = 60) |
Incomplete outcome data (attrition bias) After 3 months | Low risk | Comment: No dropouts reported, and data reported as being based on all wrists that were randomised (n = 60) |
Selective reporting (reporting bias) | Unclear risk | Comment: No protocol available, and outcome data not reported for all outcomes at all time points, but unclear if this was related to the nature of the findings |
Other bias | High risk | Quote: "The same treatment method from a single envelope was implemented for both hands of cases having bilateral CTS (10 of 40 cases) not to influence the study results." Comment: There were 40 participants, with 60 wrists affected. Analysis was based on the number of wrists, and there was no attempt to adjust the analysis for the correlation between wrists. |