Bardak 2009.
Methods | Randomised controlled trial Blinded outcome assessors Ethics approval and informed consent obtained |
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Participants | Total n = 111 (111 wrists) randomised Intervention group 1 n = 41 (41 wrists) randomised; 41 (41 wrists) completed Intervention group 2 n = 35 (35 wrists) randomised; 35 (35 wrists) completed Intervention group 3 n = 35 (35 wrists) randomised; 35 (35 wrists) completed 3 males, 108 females Mean ± SD age: Intervention group 1: 33 ± 9.6 yrs Intervention group 2: 26 ± 10.3 yrs Intervention group 3: 22 ± 9.9 yrs Mean± SD duration of CTS symptoms: Intervention group 1: 13.3 ± 8.6 months Intervention group 2: 12.9 ± 8.8 months Intervention group 3: 19 ± 16.3 months Inclusion criteria: 1. Diagnosed according to Lundborg classification as intermediate stage CTS, characterised as nocturnal increase in the carpal tunnel tissue pressure Exclusion criteria: 1. Diagnosed according to Lundborg classification as early stage or late stage CTS 2. Had diabetes mellitus 3. Had thyroid diseases 4. Had rheumatoid arthritis 5. Had peripheral neuropathy 6. Had cervical radiculopathy 7. Had CTS with thenar atrophies 8. Were pregnant 9. Had history of steroid injections or splinting 10. Had bilateral CTS |
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Interventions | Intervention group 1: standard conservative treatment consisting of a neutral splint worn day and night for the first three weeks and then at night only for the next three weeks, and 3 mg betamethasone (steroid) injection into the carpal groove. Intervention group 2: standard conservative treatment (see above) plus tendon and median nerve gliding exercises performed at home 3 times a day with every particular exercise repeated 5 times for a period of 6 weeks (exercises were demonstrated by a physiotherapist initially and participants received a brochure describing the exercises, and were asked to complete the exercises at home with a weekly follow‐up with the physiotherapist to ensure the exercises were being performed properly). Intervention group 3: tendon and median nerve gliding exercises performed at home 3 times a day with every particular exercise repeated 5 times for a period of 6 weeks (see above) |
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Outcomes | Outcomes assessed at baseline and 8 weeks after treatment ended: 1. Symptom total point, calculated as the sum of five scores (scored as symptomatic = 1 point or asymptomatic = 0 points) for five symptoms (hand pain, tingling, numbness, nocturnal numbness, and interrupted sleep). The total score ranges from 0 to 5, with lower scores denoting fewer symptoms 2. Functional status score, calculated as the sum of seven scores for ability to perform seven daily living activities (writing, buttoning clothes, gripping a telephone receiver, opening jars, doing housework, carrying grocery bags, bathing), each scored as 1 = easy, 2 = somewhat difficult, 3 = moderately difficult, 4 = very difficult, 5 = impossible). The total score ranges from 7 to 35, with lower scores denoting better function. 3. Phalen's test 4. Tinel's test 5. Reverse Phalen's test 6. Compression test 7. Pain measured on a VAS (scale properties not reported)* 8. Static 2‐point discrimination (mm) performed on the pulp of the 3 radial digits, and the mean value was recorded 9. Patient satisfaction measured via telephone, where participants were asked to rate themselves as asymptomatic = good, symptomatic during difficult activities = fair or persistent symptoms after the treatment = poor (measured only at 11 months post‐treatment) |
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Notes | *No data reported on this outcome in the trial publication. Requests to obtain these data from the authors were unsuccessful. Only participants with unilateral CTS were included in the study, 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) | Low risk | Quote: "For randomization of the patients into treatment groups, a biostatistician created a computer‐generated randomization list." Comment: the randomisation sequence was probably adequately concealed |
Allocation concealment (selection bias) | Unclear risk | Quote: "According to this list, numbered, sealed envelopes containing one of the treatment groups were prepared. When patients entered the study, the corresponding envelope was opened and the enclosed card determined the treatment group" Comment: it is not clear whether the sealed, numbered envelopes were opaque, so it is not clear whether the allocation sequence was adequately concealed |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Two investigators were assigned to this study. One of the investigators was blind to the therapy given to the patient and only evaluated the subjective symptoms, clinical examinations, and the functional status of the patient. These evaluations were carried out pretreatment and 8 weeks posttreatment. The second investigators was blind to the functional status and symptoms of the patients and only applied the treatment" Comment: participants and personnel delivering the intervention were probably not blind to treatment allocation, given the nature of the interventions. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Two investigators were assigned to this study. One of the investigators was blind to the therapy given to the patient and only evaluated the subjective symptoms, clinical examinations, and the functional status of the patient. These evaluations were carried out pretreatment and 8 weeks posttreatment. The second investigators was blind to the functional status and symptoms of the patients and only applied the treatment" Comment: the outcome assessor was probably blind to treatment allocation |
Incomplete outcome data (attrition bias) 3 months or less | Low risk | Comment: no drop‐outs or losses to follow‐up were reported in the trial publication, and the tables of outcome data clearly indicate that data reported are based on a complete samples of participants who were randomised |
Incomplete outcome data (attrition bias) After 3 months | Low risk | Comment: no drop‐outs or losses to follow‐up were reported in the trial publication, and the tables of outcome data clearly indicate that data reported are based on a complete samples of participants who were randomised |
Selective reporting (reporting bias) | High risk | Comment: all outcomes specified in the methods section of the publication were reported in the results section of the publication, except for the outcome, VAS pain. Further, no protocol or trial registry entry was identified, and it is not clear whether the outcome commonly measured in other CTS trials, nerve conduction, was measured as an outcome |
Other bias | Low risk | Comment: No other sources of bias identified. |