Study characteristics |
Methods |
Use of permutation table, single‐blind, independently administered
Assessor blinded
Loss to follow‐up at 1 year: 7/20 (2 excluded) |
Participants |
Central hospital, Vasteras, Sweden
Period of study recruitment: not stated
20 participants with non or minimally displaced proximal humeral fractures (7 had fracture of the greater tubercle); sling for 10 days.
Exclusion criteria: no information
17 female, 3 male; mean age 64 years, range 50 to 75 years |
Interventions |
Interventions started 10 to 12 days post injury, after removal of sling.
1. Instructed self‐exercise: participants instructed to train 5 to 10 minutes, 4 to 5 times daily. They had three training sessions (day 1, weeks 3 & 8 post injury)
2. Conventional physiotherapy: 9 sessions (average 20 to 30 minutes), 1 to 2 times each week, over 10 to 12 weeks. No thermoelectrotherapy.
Assigned: 10/10
Completed ( > 1 year): 7/6 |
Outcomes |
Length of follow‐up: 1 year; also assessed at 3, 8, 16 & 24 weeks
Range of motion: forward flexion (graph), abduction, internal & external rotation
Functional movements: placing hand on neck, placing hand on back
Pain: when placing hand on neck: combing hair (graph)
Isometric muscle strength: vertical & horizontal pushing
Change of treatment requested |
Funding and conflict of interest statements |
There was no statement on funding.
There was no statement on conflicts of interest. |
Notes |
The 2 excluded participants were in the control group: 1 died and 1 underwent an operation. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Mention of "permutation table" and "randomized controlled" trial |
Allocation concealment (selection bias) |
Low risk |
"A third person was responsible for the randomization procedure and kept the key to the permutation table" |
Blinding (performance bias and detection bias)
Functional outcomes, pain, clinical outcomes, complications |
Unclear risk |
"A second physiotherapist examined the patients. She did not know to which group the patient belonged, and the patients were instructed not to tell her." However, there is no guarantee of blinding and, for practical reasons, neither participants nor care provider were blinded. |
Blinding (performance bias and detection bias)
Death, reoperation |
Low risk |
Lack of blinding unlikely to affect assessment of these outcomes |
Incomplete outcome data (attrition bias)
Functional outcomes, pain, clinical outcomes, complications |
Unclear risk |
Participant flow provided but large loss to follow‐up (7/20 = 35%). |
Incomplete outcome data (attrition bias)
Death, reoperation |
Low risk |
Participant flow provided |
Selective reporting (reporting bias) |
Unclear risk |
Insufficient information to judge this. |
Balance in baseline characteristics? |
Unclear risk |
Incomplete data to back up claims of lack of baseline differences but a 4‐year difference in mean age between groups (66 versus 62 years). |
Free from performance bias? |
Low risk |
No indication of performance bias. |