Stergioulas 2008.

Methods	Design: Parallel group, two‐arm, triple‐blind randomised controlled trial (Greece) Interventions: Low‐level laser therapy (LLLT) plus home exercises or placebo laser therapy plus home exercises Sample size calculation: Not reported Analysis: Per protocol analysis Source of funding: Not reported
Participants	Number of participants: 74 (37 per group) Baseline characteristics: Low‐level laser therapy plus exercises group: Mean (SD) age = 55.51 (5.84) years; Male:Female = 19:12 Mean (SD) duration of symptoms: 26.5 (12.8) weeks Placebo laser therapy plus exercises group: Mean (SD) age = 56.83 (6.82) years; Male:Female = 21:11 Mean (SD) duration of symptoms: 27.1 (13.6) weeks Inclusion criteria: 1. Painful and limited passive glenohumeral mobility 2. More restricted lateral rotation (<8°) relative to abduction and medial rotation 3. No clear signs (e.g. painful arc, positive resistance testing, or loss of power) that the shoulder pain was caused by another condition Exclusion criteria: 1. Insulin‐dependent diabetes mellitus 2. Bilateral symptoms 3. Systemic inflammatory joint disease (such as rheumatoid arthritis or polymyalgia rheumatica) 4. Treatment with corticosteroid injections or physiotherapy during the preceding six months 5. Serious infection 6. Uncontrolled hypertension 7. Peptic ulceration for which oral steroids are contraindicated 8. Surgery, dislocation, or fracture(s) of the shoulder 9. Calcification about the shoulder joint 10. Pregnancy 11. A complete rotator cuff tear
Interventions	All patients were instructed to execute pendulum and pain‐free active exercises at home Low‐level laser therapy (N=37) Components of intervention: Low‐level laser therapy with a 810‐nm Galium‐Aluminum‐Arsenide (Ga‐Al‐As) laser with a continuous output of 60 mW applied to eight of the most painful points on the capsule of the glenohumeral joint (as indicated by the participant and checked with an algesiometer) for 30 seconds each, for a total dose of 1.8 J per point and 14.4 J per session Dosage: 4 minutes Frequency of administration: Two sessions per week from week 1‐4 and one session per week from week 5‐8 (12 sessions) Provider: Physical therapist Placebo laser therapy (N=37) Participants received the same interventions as described above, except that placebo laser therapy was provided
Outcomes	Outcomes assessed at the end of four and eight weeks treatment, and at eight weeks follow‐up (16 weeks post‐randomisation). No primary outcome was reported by the trialists 1. Overall, night, and activity‐related pain using a 100mm visual analogue scale, with end points marked "no pain" at one end and "worst pain" at the other 2. Shoulder pain and disability index (SPADI) (0‐100 scale where a higher score indicates worse pain and/or disability) 3. Croft shoulder disability questionnaire, which includes 22 items which participants answer each as "yes" or 'no", and the number of positive responses is summed to give a score ranging from 0‐22 with higher scores indicating more severe disability 4. Disability of the Arm, Shoulder, and Hand (DASH) questionnaire, for which subjects gave their answers to each of 30 items. The DASH score is expressed as a percentage 5. Heath Assessment Questionnaire (HAQ), which is a 19‐item, arthritis‐specific functional assessment measure. Patients were asked to rate two or three items each in eight areas of daily life. Each item on the HAQ is scored on a scale from 0 (no disability) to 3 (greatest disability) 6. Active range of motion in flexion, abduction, and external rotation using an inclinometer 7. Adverse events
Notes	Unpublished numerical outcome data and information regarding study design (required for risk of bias assessment) provided by trialist on request.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "An assistant at the center randomized subjects into one of two groups by asking them to select one of 74 identical opaque sealed envelopes. The envelopes contained a study number and a group number: 1 (placebo) or 2 (laser). The group number corresponded to the settings on a switch on the laser unit" Comment: An adequate method was used to generate the allocation sequence
Allocation concealment (selection bias)	Low risk	Quote: "An assistant at the center randomized subjects into one of two groups by asking them to select one of 74 identical opaque sealed envelopes. The envelopes contained a study number and a group number: 1 (placebo) or 2 (laser). The group number corresponded to the settings on a switch on the laser unit" Comment: An adequate method was used to conceal the allocation sequence
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "Neither the assistant of the center, the treating physiotherapists, nor the patients had any knowledge of which group was receiving the active laser treatment." Comment: Participants and personnel were blind to treatment
Blinding of outcome assessment (detection bias) Self‐reported outcomes	Low risk	Quote: "Neither the assistant of the center, the treating physiotherapists, nor the patients had any knowledge of which group was receiving the active laser treatment." Comment: Blinded participants self‐reported pain and function
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	Quote: "A physical therapist at the center, who was unaware of the treatment type being received by each patient, performed the clinical assessments at baseline and at weeks 4, 8, and 16." Comment: Blinded outcome assessors measured range of motion
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "Eleven patients (six from the experimental group and five from the control group) left the study to seek another treatment method because they still had symptoms after six treatments. The study was completed with 63 patients." Comment: The number of dropouts (and reasons for this) were similar between the groups and are unlikely to have biased the results
Selective reporting (reporting bias)	Low risk	Comment: Numerical outcome data was fully reported for overall pain, night pain, and activity‐related pain. Data for all other outcomes was reported in Figures as means with unlabelled error bars and an indication of whether differences between groups were statistically significant (P<0.05) or not. However, complete numerical data for these partially reported outcomes was provided by the trialist on request
Other bias	Low risk	Comment: No other sources of bias identified