Kumnerddee 2010.
Methods | Randomised controlled trial No blinding reported Ethics approval and informed consent obtained |
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Participants | Total N = 61 participants (61 wrists )randomised Intervention group 1 N = 31 participants (31 wrists) randomised; 30 participants (30 wrists) completed Intervention group 2 N = 30 participants (30 wrists) randomised; 30 participants (30 wrists) completed 6 males, 54 females* Mean ± SD age:* Intervention group 1: 51.73 ± 8.92 years Intervention group 2: 50.37 ± 9.01 years Mean ± SD duration of CTS symptoms:* Intervention group 1: 8.32 ± 7.68 months Intervention group 2: 12.12 ± 15.71 months Inclusion criteria: 1. People with mild to moderate CTS Exclusion criteria: 1. Severe degree CTS 2. Peripheral neuropathy 3. Pregnancy 4. Tendinitis or arthralgia in wrist or hand 5. Obvious space occupying lesion at the wrist 6. Thenar muscle atrophy 7. History of local steroid injection 8. History of carpal tunnel surgery 9. Inability to discontinue analgesics 10. Unwillingness to participate in the present study. |
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Interventions | Intervention group 1: Prefabricated volar neutral wrist splint worn at night only for five weeks. The splint restricted flexion motion of the wrist by a metallic bar inserted within the volar aspect of the splint whereas the extension motion was relatively controlled by neoprene and Velcro strap over the dorsal aspect of the hand and forearm. Intervention group 2: Ten sessions of electro‐acupuncture were performed twice a week. Six acupoints including HeGu (LI 4), QuChi (LI 11), DaLing (PC 7), LaoGong (PC 8), and two BaXie points (EX‐UE9) were chosen in respect to the meridiens contributing to the affected area. All needles except EX‐UE9 points were connected with the SDZ‐II nerve and muscle stimulator (Hwato, Suzhou, China) generating 1 Hz continuous direct current for 30 minutes. |
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Outcomes | Outcomes assessed at baseline and at the end of five weeks treatment:** 1. Symptoms using the Thai version of the Boston Carpal Tunnel Questionnaire, calculated as the mean of 11 items scored from 1 (normal) to 5 (worst symptoms) 2. Pain using a 100mm visual analogue scale 3. Function using the Thai version of the Boston Carpal Tunnel Questionnaire, calculated as the mean of eight items scored from 1 (normal) to 5 (worst disability). 4. Adverse effects 5. Analgesic intake |
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Notes | *Data reported only for participants completing trial (n = 60) *The results of all outcomes were reported as both endpoint and change from baseline values. There were some differences between endpoint and change from baseline values in terms of statistical significance, though to minimise selective inclusion bias, we chose to be consistent and only include endpoint values (as we included endpoint values where available for all other studies included in the review). Sixty per cent of participants in the night splinting group had bilateral CTS, whereas 70% of participants in the acupuncture group had bilateral CTS. However, the trialists reported that "In case of bilateral CTS, only the more severe hand was evaluated", 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) | Unclear risk | Quote: "Block randomization was carried out using Stata program version 10.0 (STATA Corp, LP. College Station, Tx) to allocate subjects into an acupuncture group (Acu) and a night splinting group (NS)." Comment: No information on how the random sequence was generated was reported. |
Allocation concealment (selection bias) | Unclear risk | Quote: "Block randomization was carried out using Stata program version 10.0 (STATA Corp, LP. College Station, Tx) to allocate subjects into an acupuncture group (Acu) and a night splinting group (NS)." Comment: No information on how the random sequence was concealed from individuals responsible for allocating participants was reported. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Pros and cons of all choices for the treatments of CTS were explained. Individuals who accepted both acupuncture and night splinting were asked to sign informed consent forms. Quote: " The present unblinded study may be at risk of assessment bias". Comment: Given the nature of the interventions delivered, it is unlikely that participants and personnel delivering the interventions could be blinded. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "Pros and cons of all choices for the treatments of CTS were explained. Individuals who accepted both acupuncture and night splinting were asked to sign informed consent forms. Quote: " The present unblinded study may be at risk of assessment bias". Comment: Given the nature of the interventions delivered, it is unlikely that participants and personnel delivering the interventions could be blinded. Given that only self‐reported outcomes were measured, it is unlikely that outcome assessors (participants) could have been blinded. |
Incomplete outcome data (attrition bias) 3 months or less | Low risk | Quote: "One subject in the NS [night splinting] group dropped out for operative treatment". Comment: Number of drop‐outs was small and reasons for this were reported, and are unlikely to have an impact on the results. |
Selective reporting (reporting bias) | Low risk | Comment: All outcomes reported in the methods section were reported fully in the results section of the publication. |
Other bias | Low risk | Comment: No other sources of bias identified. |