Bilgici 2010.
| Methods | Randomised controlled trial No blinding reported Ethics approval and informed consent obtained It is unclear whether randomisation occurred at the level of participants or wrists, and whether all bilateral CTS participants received the same or different intervention for each wrist |
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| Participants | Details of sampling frame: Total N randomised = 34 participants (49 wrists) randomised; 31 participants (45 wrists) completed Intervention group 1 N = 16 participants (24 wrists) randomised; 15 participants (23 wrists) completed Intervention group 2 N = 18 participants (25 wrists) randomised; 16 participants (22 wrists) completed Group 1: 5 males; 10 females Group 2: 4 males; 12 females Group‐specific sex only reported for participants who completed trial. Overall 24 women and 10 men were randomised Mean ± SD (range) age: Group 1: 47.33 ± 7.44 Group 2: 44.15 ± 9.30 Group‐specific age only reported for participants who completed trial Mean ± SD (range) duration of CTS symptoms: Group 1: 46.33 ± 34.04 months Group 2: 46.29 ± 61.36 months Group‐specific duration of symptoms only reported for participants who completed trial Inclusion criteria: 1. Had clinical symptoms and signs of CTS confirmed by standard electrodiagnosis, with no abnormalities in the radial or ulnar nerve. Exclusion criteria: 1. Had thenar atrophy or spontaneous activity (fibrillation potentials and positive sharp waves) on electromyographic examination of the abductor pollicis brevis muscle 2. Pregnant 3. Had previous wrist trauma 4. Had a history of steroid injection into the carpal tunnel 5. Had rheumatic diseases 6. Had cervical radiculopathy 7. Had diabetes or other pathologic conditions predisposing to peripheral neuropathies |
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| Interventions | Group 1: ultrasound treatment delivered under water at a frequency of 3MHz and with an intensity of 1.5W/cm2 for five minutes, five times per week for four weeks. Group 2: local corticosteroid injection plus neutral‐positioned wrist splint worn as much as possible during the day and night for four weeks. Local corticosteroid injection was given using a 22‐gauge needle at the proximal part of the carpal tunnel to the wrist crease just medial to the tendons of the flexor radial muscle involving a single 4 mg dexamethasone injection without lidocaine |
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| Outcomes | Outcomes assessed at baseline, at the end of the 4 week treatment period, and at four weeks post‐treatment. 1. Symptoms using the Turkish‐translated Boston Carpal Tunnel Questionnaire, calculated as the mean of 11 items scored from 1 (mildest) to 5 (most severe) 2. Pain using a VAS 3. Function using the Turkish‐translated Boston Carpal Tunnel Questionnaire, calculated as the mean of 8 items scored from 1 (no difficulty in the activity to 5 (cannot perform the activity at all) 4. Grip strength measured using a hand‐held dynamometer, where the participants positioning was standardised and the average force of 3 consecutive trials was calculated 5. 2‐point discrimination performed on the pulp of three radial digits and the mean recorded 6. Nerve conduction: median nerve motor distal latency (msec), median sensory nerve conduction velocity (m/sec) 7. Adverse effects |
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| Notes | Analysis was undertaken at the wrist‐level for all outcomes, though some participants in each group had bilateral CTS. It is not clear whether bilateral CTS participants received the same intervention for both wrists. The trialists did not report how the correlation between both wrists was accounted for in the analysis, and attempts to clarify this information from the trialists were unsuccessful. Therefore, it is not clear whether a unit of analysis error occurred. No attempt was made to adjust outcome data. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "The randomization was performed by using sequentially numbered and sealed opaque envelopes. Following the baseline assessment, patients were randomised to either ultrasound treatment (group A) or local corticosteroid injection plus splinting (group B)." Comment: no information on how the random sequence was generated was provided |
| Allocation concealment (selection bias) | Low risk | Quote: "The randomization was performed by using sequentially numbered and sealed opaque envelopes. Following the baseline assessment, patients were randomised to either ultrasound treatment (group A) or local corticosteroid injection plus splinting (group B)." Comment: the allocation sequence was probably adequately generated |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: due to the nature of the interventions delivered (ultrasound versus splint plus corticosteroid injection), it is unlikely that participants and personnel were unaware of treatment allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "All patients were examined by the same physician". Comment: the authors did not report whether the outcome assessor of objective outcomes was blind to treatment allocation |
| Incomplete outcome data (attrition bias) 3 months or less | Low risk | Quote: "A total of 49 hands of 34 patients (24 women and 10 men) were enrolled in this study. 16 patients were randomly assigned to the group A, and 18 patients were randomly assigned to the group B. Three patients did not complete the 8 week follow‐up. One patient in group B did not allow to be injected into her hand after randomization. Two patients (one in each group), could not be reached and were lost to follow‐up. They were excluded from the study and data analysis. Thus, 15 patients (23 hands) in the Group A, and 16 patients (22 hands) in the Group B completed the follow‐up at 8 weeks" Quote: "The per‐protocol analyses included 45 hands". Comment: The overall amount of attrition, and reasons for this, is small and relatively similar across groups, and unlikely to have affected the results of outcomes |
| Selective reporting (reporting bias) | Low risk | Comment: all outcomes specified in the Methods section were reported in the Results section in sufficient detail to be included in a meta‐analysis |
| Other bias | Low risk | Comment: No other sources of bias identified. |