Lefevre‐Colau 2007.

Study characteristics
Methods	Randomised using block randomisation (under supervision of a statistician) and telephone to an independent researcher with patient details Assessor blinding: yes Loss to follow‐up at 6 months: 10 (all had difficulties in travelling to the hospital for scheduled sessions)
Participants	Cochlin Hospital, Paris, France Period of study recruitment: October 2002 to March 2005 74 participants, over 20 years old, with non‐operatively treated impacted ("stable") fractures, including 34 minimally displaced (1‐part fracture); 16 2‐part (surgical neck or greater tuberosity (1)); and 24 3‐part (surgical neck and greater tuberosity) (Neer). (AO classification also given.) Written consent Exclusion criteria: pre‐existing shoulder pathology, neurological upper‐limb disorder, indication for shoulder surgery, multiple injuries, high‐energy trauma, or difficulties with language or unable to understand rehabilitation programme or other treatment information 54 female, 20 male; mean age 63 years
Interventions	Intervention started within 72 hours after fracture. 1. Early mobilisation: active rehabilitation begun within 72 hours of fracture: 2‐hour sessions supervised by a physiotherapist, 5 times a week. Progressing from physical techniques to manage pain, then passive motion, performed by physiotherapist, in a) abduction, with arm suspension and participant supine (session 1); passive range of motion in forward elevation with the participant in a lateral supine position (session 2), with addition of external rotation with the participant in a seated position at session 8. After 3 weeks, sessions occurred twice a week without arm suspension. Participants wore a sling between sessions for 4 to 6 weeks, depending on the level of pain. After 6 weeks, active range of motion was begun during weekly sessions. Strengthening began at 3 months in twice‐monthly sessions. Participants underwent a total of 32 sessions. 2. Usual care, starting with 3 weeks of sling immobilisation. Then 2‐hour sessions supervised by a physiotherapist 4 times a week for 4 weeks. Passive mobilisation in all planes without arm suspension was performed by physiotherapist. Participants kept their arm in a sling between sessions for 1 to 3 additional weeks, depending on pain level. Then sessions were scheduled 2 times weekly for 5 weeks. Active range‐of‐motion exercises began after 6 weeks. After 9 weeks of rehabilitation, sessions occurred twice monthly until 6 months. Each participant underwent a total of 33 sessions. Participants used oral analgesics to manage pain. After 4 to 6 weeks, participants were advised to perform daily exercises at home. Participants were discharged from the study at 6 months.
Outcomes	Length of follow‐up: 6 months, also 6 weeks and 3 months Functional assessment (Constant score: split into subjective and objective components) Pain Patient satisfaction Range of motion: abduction, anterior elevation, lateral rotation Complications: non‐union (0); fracture displacement (0); treatment (injection) for subacromial impingement syndrome Compliance
Funding and conflict of interest statements	Funding support for authors to conduct the work was received from the Department of Clinical Research of the Assistance Publique‐Hospitaux de Paris (APHP). The authors stated they had received no funding from a commercial entity in relation to the work, and implied no conflicts of interest.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Block randomization involved choosing randomly from among blocks of lengths 4 and 2 to prevent the risk of predictability."
Allocation concealment (selection bias)	Low risk	"After completion of the trial entry details, an independent researcher responsible for treatment allocation was contacted by telephone."
Blinding (performance bias and detection bias) Functional outcomes, pain, clinical outcomes, complications	Unclear risk	"Outcome measures were recorded by two physicians, including one of the authors (F.F.), who were blinded to the treatment assignments." However, care providers and participants were not blinded to allocation.
Incomplete outcome data (attrition bias) Functional outcomes, pain, clinical outcomes, complications	Unclear risk	Data were unavailable for 10 participants (5 in each group) who were lost to follow‐up because of difficulties in travelling to the hospital. Their characteristics were reported not to differ from those who attended.
Selective reporting (reporting bias)	Unclear risk	Insufficient information to judge this; retrospective trial registration
Balance in baseline characteristics?	Low risk	Good balance in baseline characteristics
Free from performance bias?	Low risk	Rehabilitation was standardised and "delivered by physiotherapists who were experienced in the field".