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. 2023 Feb 27;2023(2):CD010003. doi: 10.1002/14651858.CD010003.pub2

Boonhong 2017.

Study characteristics
Methods Study design: 3‐month randomised, single‐blind, controlled trial
Setting: outpatient unit and electrodiagnostic laboratory of the Department of Rehabilitation Medicine, King Chulalongkorn Memorial Hospital, Bangkok, Thailand
Participants Details of sampling frame:
Total n assessed for eligibility = 128 patients 
Total n excluded pre‐randomisation = 74 patients
Total n randomised = 54 participants (hands)
Total n available for follow‐up = 54 participants (hands)
Total n analysed = 54 participants (hands)
Intervention group 1 (splint) n = 28 participants (hands)
Intervention group 2 (control) n = 26 participants (hands)
Gender distribution:
Intervention group 1 (splint):  1 male;  27 female
Intervention group 2 (control):  3 male;  23 female
Mean ± SD age:
Intervention group 1 (splint): 53 ± 12.4 years
Intervention group 2 (control): 53.6 ± 12.2 years
Mean ± SD duration of CTS symptoms:
Intervention group 1 (splint): 6.7 ± 6.6 months
Intervention group 2 (control): 6.1 ± 6.6 months
Inclusion criteria:

  1. Symptoms associated with CTS

  2. Physical examination and unilateral or bilateral electrodiagnostic study

  3. Mild‐to‐moderate CTS

  4. Willing to join the study


Exclusion criteria:

  1. CTS previously treated with steroid injection or surgery

  2. History of hand or wrist injury

  3. Diagnosed as cervical radiculopathy or peripheral neuropathy

  4. Underlying disorders resulting from poorly controlled diabetes mellitus

  5. Pregnancy

  6. Other metabolic diseases

  7. Exclude severe cases of CTS (CMAP amplitude less than 5.0 mV)


CTS diagnostic criteria (case definition):
Electrodiagnostic tests of  sensory and motor nerve conduction were performed at baseline to confirm the diagnosis of mild to moderate CTS (to exclude severe cases of CTS (CMAP amplitude less than 5.0 mV) and other neurological conditions).
CTS severity: 
Mild‐to‐moderate CTS
Interventions Group 1 ‐ splinting group: a commercially available adjustable wrist splint that was properly fitted and that immobilised the wrist in the neutral position. Participants were advised to wear the splint as often as possible during the daytime as well as night‐time (during the 3‐month duration of the study) to achieve the maximum effectiveness.
Group 2 ‐ control group: received only condition‐related patient instructions and education pamphlet
Both groups: Participants were given instruction regarding the nature of CTS and advised to avoid full extension and flexion of the wrist, reduce heavy work activities, and avoid repetitive movements. An education pamphlet was given to participants to learn more by themselves.
Outcomes Outcomes were measured at baseline and at 3 months after the start of treatment

  1. BCTQ symptom severity score (1 to 5 higher is worse)

  2. BCTQ functional status score (1 to 5 higher is worse)

  3. SDLs (ms)

  4. DMLs (ms)

  5. Mean time of splint use during treatment period

  6. Adverse events
Funding The authors gratefully acknowledge the Ratchadapiseksompoj Fund of the Faculty of Medicine, Chulalongkorn University for financial support. Grant number is RA 53/54(2).
COI The authors had no conflict of interest to declare.
Notes The article did not report the SD for duration of CTS symptoms but we calculated it from the P value. 
The article reported the BCTQ symptom severity and functional status as median (IQL 25, IQL 75). There was no explanation for IQL 25 and IQL 75 and we assumed they meant 25th percentile and meant 75th percentile, and calculated IQR and SD based on this assumption. The calculation gave reasonable SD values and the study did not get particularly high or low weight in the analysis.
Participants were not allowed other medication, such as analgesic drugs or NSAIDs.
All participants in the splinting group reported being able to use their splint during both daytime and night‐time. Mean duration of splint wear was 6.2 ± 2.5 hours/day (min = 2 hours, max = 11 hours) and 8.0 ± 2.0 hours/day (min = 4 hours, max = 11 hours) for daytime and night‐time, respectively.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The randomized sequence was computer‐generated with results sealed in opaque, tamper‐proof, numbered envelopes."
Allocation concealment (selection bias) Low risk Quote: "The randomized sequence was computer‐generated with results sealed in opaque, tamper‐proof, numbered envelopes." Comment: No further elaboration of whether the concealment was ensured, but likely that it was
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "A well‐trained assistant who was blinded to the patient treatments and was not involved in patients’ treatment, explained the questionnaire to the participants without any guide and let them answer independently."
Comment: However, splinting and no treatment/education are obviously different from each other, therefore unlikely that the participants were blinded
Blinding of outcome assessment (detection bias)
All outcomes High risk Quote: "All electrodiagnostic studies were conducted by an examiner who was blinded to the patient treatment groups."
Comment: 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: All participants were accounted for; dropouts and attrition did not happen.
Selective reporting (reporting bias) Unclear risk Quote: "The protocol for this study has been approved by the Institutional Review Board of the Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand."
Comment: All the outcomes specified in the methods reported, but study protocol was not available for reading, therefore the risk of bias was unclear.
Other bias Low risk Comment: No other risk of bias detected