Zinnuroglu 2010.
Methods | Quasi‐randomised controlled trial No blinding Ethics approval and informed consent obtained |
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Participants | Total N = 27 (27 wrists) randomised; 24 participants (24 wrists) completed Intervention group N = 14 participants (14 wrists) randomised, 13 participants (13 wrists) completed Control group N = 13 participants (13 wrists) randomised, 11 participants (11 wrists) completed 1 male, 26 females Mean ± SD age:* Intervention group: 46.5 yrs (range 35 to 58 yrs) (SD not reported) Control group: 47.23 yrs (range 38 to 65 yrs) (SD not reported) Inclusion criteria: 1. Aged 35 to 65 years 2. Have mild or moderate idiopathic CTS Exclusion criteria: 1. Conditions that may cause secondary CTS, such as diabetes mellitus, rheumatoid arthritis, pregnancy, hypothyroiditis, renal insufficiency, fracture of carpal bones, ulna or radius, and peripheral neuropathy or any diseases which may cause peripheral neuropathy. |
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Interventions | Intervention: Carpal lock worn for two weeks continuous use followed by 2.5 months of nightly use. The wrist angle was adjusted to be in 15° of extension and the forearm was in neutral position. MCP joints were free to move, therefore finger and forearm movements were not restricted. Orthosis was fixed with Velcro straps which were on the forearm and palmar regions. Group 2: Volar supporting orthosis worn for two weeks continuous use followed by 2.5 months of nightly use. The orthosis was constructed with the same material as the carpal lock, but MPC joints, wrist and forearm movements were restricted and instead of dorsal support, volar support was used. Wrist and forearm angles were similar and MCP joints were in approximately 10° to 15° flexion. |
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Outcomes | Outcomes assessed before and at the end of three months treatment: 1. Pain using a 10 cm visual analogue scale 2. Dysaesthesia (numbness) using a 10 cm VAS 3. Nerve conduction: distal motor latency of the median nerve (msec), mixed nerve conduction of wrist‐elbow segment, sensory conduction velocity of second finger‐to‐wrist segment (metres/sec), sensory conduction velocity of palm‐to‐wrist segment (metres/sec), sensory conduction velocity of wrist‐elbow segment (metres/sec), latencies of the compound motor action potentials (mV), latencies of the sensory nerve action potentials (µV) |
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Notes | *Data only reported for participants completing treatment (n=24) In participants with bilateral CTS, only one wrist was randomly selected for treatment and evaluation, so a unit of analysis error resulting from the correlation between two wrists in bilateral CTS participants could not have occurred. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quote: "Twenty‐seven patients with CTS were allocated into 2 groups, according to their date of admittance. All patients admitted during 1 week were assigned to the same group. In the following week, newly arriving patients were assigned to the second group. Similar numbers of patients were included in the two groups, as the numbers of weekly patient appointments were comparable." Comment: A non‐random allocation sequence was used. |
Allocation concealment (selection bias) | High risk | Quote: "Twenty‐seven patients with CTS were allocated into 2 groups, according to their date of admittance. All patients admitted during 1 week were assigned to the same group. In the following week, newly arriving patients were assigned to the second group. Similar numbers of patients were included in the two groups, as the numbers of weekly patient appointments were comparable." Comment: A non‐random allocation sequence was used, so the allocation sequence was not able to be adequately concealed from individuals responsible for recruiting participants. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Another limitation of our study is that investigators were not blinded to the treatment protocol." Comment: Not enough information to determine whether participants were blinded to treatment allocation, but due to the nature of the interventions, it is unlikely that participants would not know which treatment they were receiving. Personnel were not blinded to treatment allocation |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "Another limitation of our study is that investigators were not blinded to the treatment protocol." Comment: Outcome assessors were not blinded to treatment allocation. |
Incomplete outcome data (attrition bias) 3 months or less | Low risk | Quote: "Two patients from the volar‐supporting orthosis group and another from the carpal lock group with bilateral CTS who did not comply with orthosis use as requested were excluded from the study." Comment: Withdrawals were reported by authors and the exclusion of these is not likely to significantly bias the results (their inclusion probably would have biased the results). |
Selective reporting (reporting bias) | High risk | Quote: "There were no significant changes in distal motor latencies, mixed NCV values, or compound muscle action potential or sensory nerve action potential amplitudes." Comment: This is the only information the authors provide regarding these four outcomes (i.e., no means, SDs or P values were reported). Also, no data was reported on sensory conduction velocity of wrist‐elbow segment. |
Other bias | Low risk | Comment: No other sources of bias identified. |
CTS: carpal tunnel syndrome; EMG: Electromyography; MCP; metacarpopharyngeal; NCV: nerve conduction velocity; NSAID: nonsteroidal anti‐inflammatory drug; SD: standard deviation; VAS: visual analogue scale