De Angelis 2009.

Methods	Randomised, single‐blind controlled trial Blinded assessors Ethics approval and informed consent obtained
Participants	Total N = 120 participants (120 wrists) randomised Intervention group N = 61 participants (61 wrists) randomised, 45 participants (45 wrists) completed Control group N = 59 participants (59 wrists) randomised, 46 (46 wrists) participants completed 17 males and 103 females randomised; 12 males and 79 females completed Mean ± SD age:* Intervention group: 46.3 ± 7.9 years Control group: 46.0 ± 11.8 years Inclusion criteria: 1. Pain, numbness and paraesthesias and/or hypoaesthesia in the median nerve distribution 2. Phalen test positive 3. CTS exclusive or predominant in one hand 4. Electrophysiological diagnosis of CTS Exclusion criteria: 1. Previous CTS surgery or intracarpal steroid injections 2. Rheumatoid arthritis 3. Clinical and electrophysiological signs of polyneuropathy 4. Wrist trauma 5. Coexisting cervical radiculopathies 6. Brachial plexopathies or more proximal median mononeuropathies 7. CTS related to systemic diseases 8. Fibromyalgia 9. Pregnancy 10. Age lesser than 18 years
Interventions	Intervention: The wrist splint CAMP TIELLE model 1.2 (TIELLE SpA, Milano, Italy) was worn every night for 3 months. The splint immobilised the wrist in a dorsiflexion position with an external angle of 30° and internal angle of 16°. Control: The hand brace MANU (developed by Manente 2001) was worn every night for 3 months. It was made of soft tissue without rigid components and consisted of: (i) a palmar strap with a Velcro adjustable fastening to tighten the distal heads of the second and fifth metacarpal bones; (ii) a triangular prism‐shaped pad positioned dorsal to digits II and V, producing slight stretching of digits III and IV; (iii) a dorsal strap connected to a wrist band with a Velcro adjustable fastening; and (iv) a component that connects and stabilizes the other parts. The hand brace did not impede thumb‐index finger pinch, thumb‐little finger opposition and wrist flexion and extension.
Outcomes	Outcomes assessed at baseline, at the end of three months treatment, and at six months after the end of treatment (i.e., 9 months from baseline): 1. Symptoms using the Italian version of the Boston Carpal Tunnel Questionnaire (rates 11 items on ordinal scale from 1 to 5; the verbal descriptors of the 1 to 5 scale were not reported)** 2. Function using the Italian version of the Boston Carpal Tunnel Questionnaire (rates 8 items on ordinal scale from 1 to 5; the verbal descriptors of the 1 to 5 scale were not reported)** 3. Pain using a 100 mm VAS (with the left sided verbal descriptor being ‘no pain’ and the right sided verbal descriptor being ‘worst pain’). Participants were instructed to place a mark on the line to report the intensity of the sensation being experienced. The pain score was identified by measuring the millimetres from the left end of the scale to the subject’s mark.** 4. Paraesthesias using a 100 mm VAS (with the left sided verbal descriptor being ‘no paresthesias' and the right sided verbal descriptor being ‘worst paresthesias'). Participants were instructed to place a mark on the line to report the intensity of the sensation being experienced. The pain score was identified by measuring the millimetres from the left end of the scale to the subject’s mark.** 6. Nerve conduction: median nerve distal motor latency (ms), median nerve sensory conduction velocity (m/s), and sensory nerve action potential (SNAP) amplitude (µV).** 7. Adverse effects: At the end of 3 months treatment participants were assessed for whether there were adverse effects to the treatment. No report on how this was assessed and recorded.
Notes	*Data reported only for participants completing trial (n = 91) **The authors reported outcome data as means and 95% CIs of the means. 95% CIs were converted to SDs using the RevMan calculator. In participants with bilateral CTS, the wrist with the most severe symptoms was chosen for treatment and evaluation, 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: "The randomization was carried out by using a simple randomization process. Each subject meeting the inclusion and exclusion criteria for entering the trial has been randomly assigned to one of the two groups in a 1:1 ratio." Comment: Not enough information to determine the adequacy of the randomisation sequence generation.
Allocation concealment (selection bias)	High risk	Quote: "The randomization process of assigning individual subjects to their groups was performed by an unblinded investigator." Comment: The allocation sequence was not adequately concealed until interventions were assigned.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "To optimize blinding, the patients were reminded, immediately before their visit, to reveal information regarding their treatment only to the treating physician." Comment: Participants were unlikely to have been unaware of which treatment they received.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "The physicians who assisted the patient in filling the BCTQ and VAS scales and performed conduction velocities (MVDA and FP) were blinded for the allocated treatment, whereas the treating physician (AU) was not blinded. To optimize blinding, the patients were reminded, immediately before their visit, to reveal information regarding their treatment only to the treating physician." Comment: Outcome assessors were probably blind to treatment allocation.
Incomplete outcome data (attrition bias) 3 months or less	Low risk	Quote: "Twenty‐nine subjects were lost to follow‐up, 13 (44.8%) in the MANU  group and 16 (55.2%) in the CAMP TIELLE  group....As the withdrawal from the study at T1 and T2 was balanced in both groups, we chose to include in the statistical analysis only those subjects who completed the study. This has the advantage to compare longitudinally the same subjects without the need to extrapolate for missing data." Comment: The number of drop‐outs and reasons for these are clearly reported. It can be safely assumed that the data reported in tables are based on 91 participants (i.e., all of those who completed the study) as this is specified in the second figure in the publication.
Incomplete outcome data (attrition bias) After 3 months	Low risk	Quote: "Twenty‐nine subjects were lost to follow‐up, 13 (44.8%) in the MANU  group and 16 (55.2%) in the CAMP TIELLE  group....As the withdrawal from the study at T1 and T2 was balanced in both groups, we chose to include in the statistical analysis only those subjects who completed the study. This has the advantage to compare longitudinally the same subjects without the need to extrapolate for missing data." Comment: The number of drop‐outs and reasons for these are clearly reported. It can be safely assumed that the data reported in tables are based on 91 participants (i.e., all of those who completed the study) as this is specified in the second figure in the publication.
Selective reporting (reporting bias)	Low risk	Comment: All of the outcomes specified in the Methods section of the publication were reported in the pre‐specified way.
Other bias	Low risk	Comment: No other sources of bias identified.