Geler Kulcu 2016.
Study characteristics | ||
Methods | Study design: Randomised 3‐arm, sham‐controlled trial Setting: Turkey |
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Participants |
Details of sampling frame:
Total n assessed for eligibility = 57
Total n excluded pre‐randomisation = 12
Total n randomised = 45 participants (65 wrists)
Intervention group 1 (splint) n = 15 (21 wrists)
Intervention group 2 (kinesiology tape) n = 15 (22 wrists)
Intervention group 3 (placebo kinesiology tape) n = 15 (22 wrists)
Post‐intervention follow‐up at 4 weeks:
Total n available for follow‐up = 40 participants (60 wrists)
Intervention group 1 (splint) n = 14 (20 wrists)
Intervention group 2 (kinesiology tape) n = 13 (20 wrists)
Intervention group 3 (placebo kinesiology tape) n = 13 (20 wrists)
Gender distribution Intervention group 1 (splint): 1 male; 13 females Intervention group 2 (kinesiology tape): 1 males; 12 females Intervention group 3 (placebo kinesiology tape): 0 males; 13 females Mean ± SD age: Intervention group 1 (splint): 51.3 ± 8.3 (range 40–65) Intervention group 2 (kinesiology tape): 49.8 ±11.5 (range 20–62) Intervention group 3 (placebo kinesiology tape): 48.95 ± 6.0 (range 40–60) Total: 50.02 ± 8.79 (20–65) years Mean ± SD (range) duration of CTS symptoms Not reported. All had CTS < 1 year Inclusion criteria 1. Mild‐to‐moderate CTS according to a nerve conduction study 2. 18 years or older 3. Symptoms for less than 1 year Exclusion criteria
CTS diagnostic criteria (case definition): 1. People diagnosed by EMG as having mild to moderate CTS (according to NCSs) CTS severity: Mild‐to‐moderate CTS |
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Interventions | Group 1 ‐ wrist orthosis: Participants were applied with a custom‐made volar thermoplastic wrist orthotic device in a neutral wrist position. The participants were encouraged to use the orthosis night and day, whenever possible, for 4 weeks. Group 2 ‐ kinesiology tape: Tape with a width of 5 cm and a thickness of 0.5 mm was used. Kinesio Tex I Strip was measured from elbow to fingertips and cut. It was folded approximately 2 blocks from the end and cut into 2 triangles on the fold. The 3rd and 4th fingers were slipped through holes and Kinesio Tex was applied on the dorsum of the hand with no tension. The position of elbow extension, wrist extension, and radial deviation was provided, and Kinesio Tex was applied from hand to medial epicondyle with 15% to 25% tension and ended at medial epicondyle with no tension. The second Kinesio Tex I Strip was measured for wrist size and cut. It was applied to the carpal tunnel region with 25% to 35% tension. This technique has been described by Kase and colleagues (Kase 1998). Applied tension to kinesiology tape were performed according to the visible pores on the kinesiology tape. Participants were taped by a doctor certified to apply kinesiology tape. Kinesiology tape was applied at the beginning of the week, to stay on for 5 days, with a 2‐day rest, a total of 4 times. Group 3 ‐ sham kinesiology tape: Tape with a width of 5 cm and a thickness of 0.5 mm was used. Kinesio Tex I Strip was applied without having the proper position and with no tension (in a manner inconsistent with the technique described in Group 1). Kinesiology tape was applied at the beginning of the week, to stay on for 5 days, with a 2‐day rest, a total of 4 times. All groups: All participants received a home exercise programme during the 4 weeks, consisting of tendon‐gliding exercises. To follow up and to improve compliance, each participant was asked to document in a supplied diary what they did, i.e. how many times they did each exercise in a day. The diaries were checked every visit. |
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Outcomes | Outcomes were assessed at 4 weeks
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Funding | Not reported | |
COI | Not reported | |
Notes | We assumed by reading the paper that the follow‐up data collection occurred at 4 weeks, but this was not explicitly stated. VAS – data analysis implied that this was a Numerical Rating Scale, not a VAS. Results from BCTQ not reported on a 1 to 5 scale. We assumed that investigators reported the total sum and divided the symptom score by 11 and the functional score by 8 (as per instructions of the scale). The number of participants and hands reported in the main text and Figure 1 were not the same. We used data from Figure 1 as these data appeared to be correct. Adherence to exercise was monitored by documenting what was done in a diary. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Patients were randomly assigned to one of the three groups using a secure system of opaque closed envelopes numbered 1–3. Wrists of the patients with bilateral CTS were allocated to the same group according to the envelope number that the patient chose. The first group received KT [kinesiology tape], the second group received sham KT, and the third group received an OD [orthotic device], performed by a researcher not involved in the study." Comment: The random sequence was probably adequately generated, as it appeared the participants randomly selected the envelope containing the randomisation allocation. |
Allocation concealment (selection bias) | Low risk | Quote: "Patients were randomly assigned to one of the three groups using a secure system of opaque closed envelopes numbered 1–3. Wrists of the patients with bilateral CTS were allocated to the same group according to the envelope number that the patient chose. The first group received KT, the second group received sham KT, and the third group received an OD, performed by a researcher not involved in the study." Comment: The allocation sequence appeared to have been adequately concealed prior to assignment of interventions. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "The investigator applying the treatments was different from the investigator evaluating the outcome measures; the latter was blind to which series of treatments (experimental KT, placebo KT, or OD) each patient was about to receive or had just received. The patients in Group 1 and Group 2 were blind to the treatments." Comment: The participants in Groups 1 and 2 were blinded to whether they were receiving the experimental or sham intervention. However, the participants in Group 3 were not blinded. Furthermore, due to the nature of the treatments, those providing treatment were unlikely to be blinded to the intervention groups. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "The investigator applying the treatments was different from the investigator evaluating the outcome measures; the latter was blind to which series of treatments (experimental KT, placebo KT, or OD) each patient was about to receive or had just received." Comment: The outcome assessors were likely blinded to the treatment group. However, 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: The number of dropouts at 4‐week follow‐up: 1) kinesiology tape group: 2/15 (13%) 2) placebo kinesiology tape group: 2/15 (13%) 3) orthotic device group 1/15 (7%) Dropouts and protocol violators are clearly documented in the flow diagram and were not included in the analysis. |
Selective reporting (reporting bias) | Unclear risk | Comment: All outcomes specified in the methods were reported, but no study protocol was available, therefore the risk was unclear. |
Other bias | Unclear risk | Quote: "Patients with bilateral symptoms were asked to complete two questionnaires, one for each hand separately." Comment: The unit of analysis was hands (with some participants contributing 2 hands to the analysis). Although unlikely, it was unclear whether a unit of analysis error may have occurred in the data analysis. |