Rioja Toro 2012.

Study characteristics
Methods	Study design: a prospective, blinded, randomised, placebo‐controlled study Setting: Traumatology and Rehabilitation Service, Spain
Participants	Details of sampling frame: Total n eligible = not reported Total n excluded pre‐randomisation = not reported Total n randomised = 49 (98 hands) Total n available for follow‐up =  unclear Total n analysed = 86 hands Intervention group 1 (splint & real laser) n = 22 hands Intervention group 2 (splint & placebo laser) n = 23 hands Intervention group 3 (real laser) n = 24 hands Intervention group 4 (placebo laser) n = 17 hands Gender distribution: Total: 3 males; 46 females Intervention group 1 (splint & real laser): not reported Intervention group 2 (splint & placebo laser): not reported Intervention group 3 (real laser): not reported Intervention group 4 (placebo laser): not reported Mean ± SD (range) age: Total: 49 ± 11.1 Intervention group 1 (splint & real laser): not reported Intervention group 2 (splint & placebo laser): not reported Intervention group 3 (real laser): not reported Intervention group 4 (placebo laser): not reported Mean ± SD (range) duration of CTS symptoms: Not reported Inclusion criteria: Mild‐to‐moderate CTS Exclusion criteria: Inflammatory diseases (rheumatoid arthritis) Traumatic causes (wrist fractures) Neurological causes (radiculopathies, polyneuropathies), Intracanal expansive processes (ganglions, tumours, osteophytes, etc.) Joint deformities of the wrists and hands Multiple sclerosis Amyotrophic lateral sclerosis Thoracic outlet syndrome Polyneuropathies Recent wrist fractures Ulnar nerve entrapment in associated wrist or elbow CTS diagnostic criteria (case definition): 1. The diagnostic criteria are those recommended by the American Academy of Emergency Medicine: 1.1. Sensory latency difference  (degree of CTS: mild < 0.5 ms; moderate 0.5‐0.8 ms; severe > 0.8 ms or not evoked) 1.2. Spontaneous activity at rest (degree of CTS: mild ‐ not; moderate ‐ not; severe ‐ yes (sometimes)) 1.3. Voluntary activity (degree of CTS: mild ‐ normal; moderate ‐ normal; severe ‐ neurogenic pattern) 1.4. DML (degree of CTS: mild ‐ normal; moderate ‐ normal or slight increase; severe ‐ augmented) 1.5. Motor potential synchronisation (degree of CTS: mild ‐ yes; moderate ‐ yes; severe ‐ desynchronised or decreased in amplitude, or both) 1.6. Motor driving speed (degree of CTS: mild ‐ normal; moderate ‐ normal; severe ‐ diminished) CTS severity:  Mild‐to‐moderate CTS
Interventions	Group 1 ‐splint during night & laser treatment Group 2 ‐ splint during night & placebo Group 3 ‐ laser treatment Group 4 ‐ control (placebo laser) For participants wearing splint: wrist orthosis with palmar metal strap was used (night‐time), without encompassing the metacarpophalangeal joints and in a neutral wrist position (0° position). In all participants treated with real laser, a total energy dose of 945 J was used in an area of 4 x 4 cm2 (59 J/cm2) and of 5 J of total dose in the same area of 4 x 4 cm2 (0.3 J/cm2) in the treatments with placebo laser. The rhythm of the sessions has been 5 per week for 4 weeks. In all of them, a careful cleaning of the skin was carried out prior to each treatment session, to avoid losses due to reflection. All participants had either not started treatment with NSAIDs, or had stopped at least 1 month before. None were undergoing local treatments with iontophoresis, ultrasounds, etc., or they had abandoned it more than a month ago.
Outcomes	Outcomes evaluated before treatment and 1 and 3 months after treatment Functional scale BCTQ scale Difference in the values of sensory latency times between the 4th‐middle finger and the 4th‐ulnar finger DML
Funding	Not reported
COI	The authors declared that they had no conflict of interest.
Notes	Article in Spanish, translation used  The number of participants and hands reported in the main text and table 6 seems to be not the same ‐ we used data from table 6, assuming that the table 6 reported hands.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "The patients who passed the selection of units A and B, went to unit C (physiotherapy) where, randomly, one wrist was treated with Lv and the other with Lp (total 49 hands with Lv and 49 hands with Lp). Also, 27 patients were randomly indicated to use a wrist orthosis with palmar metal strap (night use), without encompassing the metacarpophalangeal joints and in a neutral wrist position (0°position); in 15 of them the orthosis was put on the most affected hand, and in 12 on both hands (total 39 hands with orthosis)." Comment: Not clear how the randomisation was done
Allocation concealment (selection bias)	Unclear risk	Comment: No information regarding the method of allocation was reported.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: Blinding of real laser versus placebo laser probably possible, however, it is unlikely that blinding for orthosis was possible.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Comment: Due to the nature of the interventions, it is likely that participants were aware of which treatment they were allocated to, therefore we rated the risk as high.
Incomplete outcome data (attrition bias) 3 months or less	Unclear risk	Comment: No flowchart and not completely clear if all participants were followed up or if the authors only reported data for those that participated in the follow‐up visits.
Incomplete outcome data (attrition bias) After 3 months	Unclear risk	Comment: Numbers of participants not reported
Selective reporting (reporting bias)	Unclear risk	Comment: The outcomes were reported incompletely (only as P values from statistical analysis).
Other bias	Unclear risk	Comment: 49 participants had bilateral CTS (98 hands). The unit of analysis (hand or participant) was unclear, as the tables reported data for 86 participants.