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

Madjdinasab 2008.

Study characteristics
Methods Study design: RCT
Setting: Iran
Participants Details of sampling frame:
Total n eligible =  not reported
Total n excluded pre‐randomisation =  not reported
Total n randomised = 48 participants 
Intervention group 1 (splint) n = 24 participants 
Intervention group 2 (oral steroid) n = 24 participants 
Gender distribution:
Intervention group 1 (splint): 2 males, 22 females
Intervention group 2 (oral steroid): 2 males, 22 females
Mean ± SD age:
Intervention group 1 (splint): 43 years
Intervention group 2 (oral steroid): 40 years
Total mean: 42.19 (range 21 to 65 years)
Mean ± SD duration of CTS symptoms:
Not reported
Inclusion criteria:

  1. Clinical diagnosis of CTS for at least 1 month

  2. Electrophysiological evidence of median neuropathy (defined as having 2 or more of the following: 1. Median nerve DML recording at abductor pollicis brevis and wrist stimulating greater than 4.4 ms; 2. Median nerve antidromic sensory peak latency recording at digit II greater than 3.5 ms; 3. Difference between antidromic median sensory latency and ulnar sensory latency at digit IV greater than 0.5 ms; 4. Antidromic latency difference more than 0.5 ms between median nerve at digit II and ulnar nerve at digit V; 5. The same distance of measurement).


Exclusion criteria:

  1. Diabetes mellitus, trauma to wrist and deformity

  2. Evidence of generalised neuropathy or radiculopathy on electrodiagnostic study

  3. Advanced CTS, having wasting, marked weakness with marked axonal loss on a NCS, or nonstimulatable nerves

  4. History of peptic ulcer

  5. Previous treatment for CTS using medical or surgical therapy

  6. Pregnant women with CTS

  7. Systemic disorders like rheumatoid arthritis, hypothyroidism, amyloidosis, etc.


CTS diagnostic criteria (case definition):
Electrophysiological criteria were used for diagnosis of CTS.
CTS severity: 
Not reported
Interventions Group 1 ‐ commercially available splint: worn at night and for as long as possible during the day for 6 weeks (wrist splinting in neutral position)
Group 2 ‐ oral steroid: Prednisolone 20 mg/day for 2 weeks
Both groups were given advice to avoid extreme wrist flexion/extension, excessive hand movement and hand rest. The participants were also asked not to use additional medicines or other methods of treatment during the study period.
Outcomes Outcomes assessed at baseline and at the end of 6 weeks treatment

  1. Median and ulnar nerve SDL (ms)

  2. Median and ulnar nerve DML (ms)

  3. Median and ulnar SNCV (m/s)

  4. Median and ulnar MNCV (m/s)
Funding Not reported
COI Not reported
Notes No self‐reported outcomes (e.g. symptoms, pain) or function outcomes were reported as being measured in this study.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "They were randomly divided into two groups. Splint groups (N = 24) used splint for six weeks; and steroid group (N = 24) used oral Prednisolone 20 mg/day for two weeks."
Comment: No information reported on how the randomisation sequence was generated 
Allocation concealment (selection bias) Unclear risk Quote: "They were randomly divided into two groups. Splint groups (N = 24) used splint for six weeks; and steroid group (N = 24) used oral Prednisolone 20 mg/day for two weeks."
Comment: No information reported on how adequately the randomisation sequence was concealed
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "This double blind study was carried out in 48 idiopathic CTS patients".
Comment: The authors reported that this was a double‐blind study, but did not indicate who specifically was blinded (participants, personnel delivering the treatment, or outcome assessors). Due to the nature of the interventions (splint versus oral steroid), it is likely that participants were aware of their allocated treatment.
Blinding of outcome assessment (detection bias)
All outcomes High risk Quote: "This double blind study was carried out in 48 idiopathic CTS patients".
Comment: The authors reported that this was a double‐blind study, but did not indicate who specifically was blinded (participants, personnel delivering the treatment, or outcome assessors). Due to the nature of the interventions (splint versus oral steroid), it is likely that participants were aware of their allocated treatment.
Incomplete outcome data (attrition bias)
3 months or less Unclear risk Quote: "In splint group three patients and in steroid group two patients did not complete the study and were eliminated."
Comment: 21/24 of the splint group and 22/24 of the prednisolone group completed assessments. The reasons for participants not completing the study were not reported, so it is not possible to determine whether the dropouts could have had an impact on the results.
Selective reporting (reporting bias) Unclear risk Comment: All outcomes reported in the Methods section of the publication were reported in the Results section of the publication. However, the only reported outcomes were electrophysiologic measures. Most other CTS RCTs also measured symptoms and function and without access to a protocol for this study, we could not determine whether those clinical outcomes were measured but not reported in the publication.
Other bias Low risk Comment: No other sources of bias identified