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

Mishra 2006.

Study characteristics
Methods Study design: RCT
Setting: neurology outpatient department of a tertiary care centre, India
Participants Details of sampling frame:
Total n assessed for eligibility = 66 participants (117 hands)
Total n excluded pre‐randomisation = 26 participants
Total n randomised = 40 participants (71 hands)
Total n available for follow‐up = 40 participants (71 hands) 
Total n analysed = 71 wrists
Intervention group 1 (splint) n = 20 participants (36 wrists) 
Intervention group 2 (oral steroid) n = 20 participants (35 wrists) 
Gender distribution:
Intervention group 1 (splint): 3 males, 17 females
Intervention group 2 (oral steroid): 4 males, 16 females
Mean ± SD (range) age:
Intervention group 1 (splint): 42.91 ± 9.39 (range 23 to 60) years
Control group 2 (oral steroid): 41.57 ± 9.26 (range 28 to 60) years
Mean ± SD duration of CTS symptoms:
Intervention group 1 (splint): 6.40 ± 7.09 months
Control group 2 (oral steroid): 6.31 ± 7.50 months
Inclusion criteria:
Symptoms suggestive of CTS of at least 1‐month duration and electrophysiological evidence of median neuropathy at wrist
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 NCS or nonstimulatable nerves

  4. History of peptic ulcer

  5. Previous treatment for CTS using medical or surgical therapy

  6. Pregnancy

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


CTS diagnostic criteria (case definition):
The clinical criteria laid down by the American Academy of Neurology were used for diagnosis of CTS. The electrophysiological criteria used for the diagnosis of CTS included the presence of 2 or more of the following:

  1. Median nerve DML recording at abductor pollicis brevis and stimulating at wrist 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 of > 0.5 ms between median nerve at digit II and ulnar nerve at digit V using the same distance of measurement


CTS severity: 
Not reported
Interventions Group 1 ‐ commercially available carpal tunnel splint: worn in the neutral position at night and as much as possible during the daytime for 4 weeks. In the case of bilateral symptoms, both hands were treated. Participants were also told not use additional medicines or other methods of treatment during the study period.
Group 2 ‐ oral steroid: prednisolone 20 mg/day was taken for 2 weeks followed by 10 mg/day for another 2 weeks.
Advice to avoid extremes of wrist flexion or extension, excessive hand movement and hand rest was common to both groups.
Outcomes Outcomes assessed before treatment and at the end of 4 weeks of treatment and at 8 weeks post‐treatment:

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

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

  3. Median nerve DML (ms)

  4. Median nerve MCV (m/s)

  5. Median nerve SDL (ms)

  6. Median nerve SNCV (m/s)

  7. Adverse effects: measured as the number of participants experiencing adverse effects (e.g. discomfort and swelling of the hands and wrist)
Funding Not reported
COI Not reported
Notes Compliance was reported as excellent in steroid group, while 3 participants were not using splint regularly as prescribed (only 5 to 6 days per week instead of most of the time daily as advised) also taking NSAIDs like nimesulide and diclofenac.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Randomization was done using the table of random numbers."
Comment: The randomisation sequence was probably adequately generated.
Allocation concealment (selection bias) Unclear risk Quote: "All patients were randomly allocated to one of the following two groups: 1. Splinting in neutral position. 2. Oral steroid. Randomization was done using the table of random numbers."
Comment: Not enough information to determine whether the treatment allocation was adequately concealed until interventions were assigned
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "A prospective randomised open‐label clinical and electrophysiological study of efficacy of splinting and oral steroids for the treatment of CTS was done."
Comment: Participants were probably aware of which intervention they received.
Blinding of outcome assessment (detection bias)
All outcomes High risk Comment: 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: No withdrawals, dropouts or losses to follow‐up were reported, and the authors indicated in the results tables that data was based on all 71 randomised wrists.
Selective reporting (reporting bias) Low risk Comment: All of the study's outcomes (prespecified in the Methods section of the study report) were reported in the prespecified way.
Other bias Low risk Comment: No other sources of bias identified