Akturk 2018.
Study characteristics | ||
Methods | Study design: 2‐arm assessor‐blind RCT Setting: hospital physical therapy clinic in 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 = 58 hands (44 participants) Total n available for follow‐up = 58 hands Total n analysed = 58 hands Intervention group 1 (splint + exercise) n = 30 hands Intervention group 2 (kinesiology tape + exercise) n = 28 hands Gender distribution: Total: 6 males; 38 females Intervention group 1 (splint + exercise): 1 male hand; 29 female hands Intervention group 2 (kinesiology tape + exercise): 6 male hands; 22 female hands Mean ± SD age: Intervention group 1 (splint + exercise): 48.2 ± 9.2 Intervention group 2 (kinesiology tape + exercise): 49.2 ± 11.7 Total: aged 20–65 years Mean ± SD duration of CTS symptoms: Intervention group 1 (splint + exercise): 7.13 ± 1.96 weeks Intervention group 2 (kinesiology tape + exercise): 7.6 ± 2.5 weeks Inclusion criteria:
Exclusion criteria:
CTS diagnostic criteria (case definition): People diagnosed with mild‐to‐moderate CTS by electroneuromyography (ENMG) were included in the study CTS severity: Mild‐to‐moderate idiopathic CTS |
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Interventions | Group 1: treated with splinting. Flexion, extension, and deviation of the wrist were not allowed in the splinted group but pronation and supination were. Neutral position, volar‐assisted splints were applied and the participants were advised to wear them during the night‐time and also at daytime whenever possible for 35 days. Participant comfort when wearing splint was checked on a weekly basis. Group 2: kinesiology tape was applied using the neural and inhibition techniques recommended for CTS. Alcohol‐drenched cotton was used to clean the skin of oils and moisture with the wrist at 30° extension, the forearm in supination and the elbow in extension. For the neural technique, two 2.5 cm‐wide strips were prepared by measuring the distance from the participant’s first metacarpal joint to medial epicondyle. The 1st band for the median nerve was taped from 2nd and 3rd metacarpophalangeal joints to the medial epicondyle with medium stretch (60%) through the nerve trace. The 2nd strip was applied to the lateral epicondyle from the 4th and 5th metacarpophalangeal joints by applying the inhibition technique. A 3rd strip 4 cm wide was cut and applied to the volar face of the hand with full stretch. Taping was performed by the same physiotherapist twice a week for 5 weeks, 10 times in total. The tape was removed after 48 hours and reapplied after 24 hours of rest due to skin irritation. During this time, the participant was informed that he or she should not engage in activities that could cause excessive sweating and should not be exposed to water. Both groups: All participants were advised to report any discomfort when using the splint or kinesiology tape. The exercises for the tendons and nerve‐shifting were written down and the participants were told to carry them out every day for 35 days. Theexercise programme was given to all groups in the form of a home schedule and they were also given demonstrations. If symptoms were provoked during exercise, it was recommended to continue the exercise regimen using a smaller range of motion. Exercise compliance was monitored with a diary and checked on a weekly basis. |
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Outcomes | Outcomes evaluated before treatment and 6 weeks after treatment
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Funding | Not reported | |
COI | Not reported | |
Notes | BCTQ results reported as 10 to 50 in the table. Scale converted to 1 to 5 by dividing by 10. No information on whether the trial allowed participants to use other medication such as analgesic drugs or NSAIDs Exercise compliance was monitored with a diary and checked on a weekly basis, but nothing reported regarding the compliance with splint or kinesiology tape use. The results of compliance not provided |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization was made by drawing lots". |
Allocation concealment (selection bias) | Unclear risk | Quote: "Randomization was made by drawing lots". Comment: No information regarding the method of allocation was reported. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: blinding of participants not reported, but due to the nature of the interventions (splint versus taping), it is likely that participants were aware which treatment they were allocated to. Blinded observer is not adequate blinding regarding participant‐reported outcome (BCTQ). Quote: "An observer who was blinded to the treatment method filled in an evaluation form both before treatment and in the sixth week following treatment." |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "An observer who was blinded to the treatment method filled in an evaluation form both before treatment and in the sixth week following treatment." 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: Not reported, probably no loss to follow‐up |
Selective reporting (reporting bias) | Unclear risk | Comment: All the outcomes specified in the methods reported, but no study protocol available, therefore, the risk was unclear. |
Other bias | Unclear risk | Comment: 1) Trial reported BCTQ on a scale of 10 to 50, although normal range is from 1 to 5. As the values reported similarly in each treatment group, we transformed to values to 1 to 5, as this likely does not cause bias. 2) 14 participants had bilateral CTS. Clustering not controlled in the analyses; not clear if these 14 participants were distributed evenly 3) Gender distribution not balanced at baseline (29/30 women versus 22/28 women) |