Manente 2001.

Methods	Randomised controlled trial No blinding* Ethics approval and informed consent obtained
Participants	Total N = 83 participants (83 wrists) randomised; 80 participants (80 wrists) completed Intervention group N = 41 participants (41 wrists) randomised; 40 participants (40 wrists) completed Control group N = 42 participants (42 wrists) randomised; 40 participants (40 wrists) completed 11 males; 69 females Mean ± SD age: Intervention 46 ± 13 yrs Control 50 ± 13 yrs Inclusion criteria: 1. CTS symptoms (pain, numbness, paraesthesiae in median nerve distribution) exclusively or predominantly in one wrist 2. CTS signs (hypoaesthesia in median nerve distribution, thenar atrophy, positive Phalen's test) exclusively or predominantly in one wrist 3. At least one abnormal CTS electrodiagnostic study Exclusion criteria: 1. Previous carpal tunnel release 2. Rheumatoid arthritis 3. Systemic disease 4. Pregnancy 5. Polyneuropathy
Interventions	Intervention: Splint worn at night for four weeks Control: No treatment (asked to wait for an observational period of four weeks) for four weeks
Outcomes	Outcome assessed at two weeks and at the end of four weeks of treatment: 1. Symptoms using carpal tunnel questionnaire (rates 11 items on ordinal scale 1 to 5, with higher scores denoting worse symptoms) 2. Hand function using carpal tunnel questionnaire (rates 8 items on ordinal scale 1 to 5, with higher scores denoting worse symptoms) 3. Global impression of change (patient‐rated questionnaire rated in four categories: moderate or much improvement, minimal improvement, no change, worsening) (at 4 weeks only) 4. Nerve conduction: median motor distal latency (ms), median sensory conduction velocity (m/s), sensory nerve action potential amplitude (uV) (at 4 weeks only) 5. Changes of electrophysiological class of severity (4 weeks only) 6. Compliance and tolerability 7. Adverse effects
Notes	*Confirmed with author in personal communication. 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.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Subjects were randomized into two groups by having them select sealed envelopes containing a group assignment". Comment: Insufficient information provided to determine whether adequate method used to generate random sequence.
Allocation concealment (selection bias)	Unclear risk	Quote: "Subjects were randomized into two groups by having them select sealed envelopes containing a group assignment". Comment: It is not specified whether envelopes were opaque or sequentially numbered and distributed.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: Participants, personnel, and outcome assessors were not blinded to treatment allocation. Assessment of symptoms, functional status, and global impression of change may be biased.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Comment: Outcome assessors were not blinded to treatment group assignments meaning results for nerve conduction studies may have been biased.
Incomplete outcome data (attrition bias) 3 months or less	Low risk	Comment: Only one participant in the treatment group was lost to follow‐up and two participants in the control group were excluded after randomisation because they underwent surgery. This is unlikely to have introduced substantial bias in the comparison of outcomes for each group.
Selective reporting (reporting bias)	Low risk	Comment: All outcomes stated in the methods section of the publication were reported in the results.
Other bias	Low risk	Comment: No other sources of bias identified.