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. 2012 Jul 11;2012(7):CD010003. doi: 10.1002/14651858.CD010003

Madjdinasab 2008.

Methods Double‐blind randomised controlled trial
Not clear who was blinded (participants, personnel or outcome assessors)
Ethics approval and informed consent obtained
Randomisation occurred at the level of participants, where participants with bilateral CTS received the same intervention for both affected wrists.
Participants Total N = 48 participants randomised
Intervention group 1 N = 24 participants randomised
Intervention group 2 N = 24 participants randomised
4 males, 44 females
Mean age (SD not reported):
Intervention group 1: 43 years
Intervention group 2: 40 years
Inclusion criteria:
1. Clinical diagnosis of CTS for at least one month
2. Participant has electrophysiological evidence of median neuropathy (defined as having two or more of the following: 1. Median nerve motor distal latency 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. Patients with diabetes mellitus, trauma to wrist and deformity. 
 2. Any patient with evidence of generalised neuropathy /radiculopathy on electrodiagnostic study. 
 3. Patients with advanced CTS having wasting, marked weakness with marked axonal loss on nerve conduction study or nonstimulatable nerves. 
 4. Patients with a history of peptic ulcer. 
 5. Patients treated previously for CTS using medical or surgical therapy. 
 6. Pregnant women with CTS. 
 7. Patients with systemic disorders like rheumatoid arthritis, hypothyroidism, amyloidosis, etc.
Interventions Intervention group 1: Commercially available splint worn at night and for as long as possible during the day for six weeks.
Intervention group 2: Oral Prednisolone 20mg/day for two weeks
Both groups were given advice to avoid extreme wrist flexion/extension, excessive hand movement and hand rest.
Outcomes Outcomes assessed at baseline and at the end of six week treatment:
1. Nerve conduction: median and ulnar nerve sensory distal latency (ms), median and ulnar nerve motor distal latency (ms), median and ulnar nerve sensory conduction velocity, median and ulnar nerve motor conduction velocity
Notes There were no self‐reported outcomes (e.g. symptoms, pain) or function outcomes reported as being measured in this study.
The results of nerve conduction studies were reported as both endpoint and change from baseline values. There were no differences between endpoint and change from baseline values in terms of statistical significance, so 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).
Analysis was undertaken at the participant‐level for all outcomes, though some participants in each group had bilateral CTS. Bilateral cases had the same intervention applied to each wrist. The trialists did not report the number of bilateral CTS participants in each group, or how the correlation between both wrists was accounted for in the analysis, and attempts to clarify this information from the trialists were unsuccessful. Therefore, it is not clear whether a unit of analysis error occurred. No attempt was made to adjust outcome data.
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 20mg/day for two weeks." 
 Comment: No information on how the randomisation sequence was generated was reported.
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 20mg/day for two weeks." 
 Comment: No information on how the randomisation sequence was adequately concealed was reported.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote: "This double blind study was carried out in 48 idiopathic CTS patients". 
 Comment: The authors report that this study was a double‐blind study, but do not indicate who specifically was blinded (participants, personnel delivering the treatment, or outcome assessors).
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: "This double blind study was carried out in 48 idiopathic CTS patients". 
 Comment: The authors report that this study was a double‐blind study, but do not indicate who specifically was blinded (participants, personnel delivering the treatment, or outcome assessors).
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 completed assessments, 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 drop‐outs 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 measure symptoms and function too, and without access to a protocol for this study, we cannot determine whether those clinical outcomes were measured but not reported in the publication.
Other bias Low risk Comment: No other sources of bias identified.