| Study characteristics |
| Methods |
Method of randomisation: unknown; double‐blind
Assessor blinding: likely as code only broken at end of trial
Loss to follow‐up at 6 months: 3/48 |
| Participants |
Mansfield District General Hospital, Mansfield, UK
Period of study recruitment: November 1988 to May 1990
48 participants with minimally displaced humeral neck fractures (all Neer Group 1); 4 had epiphyseal fractures
Exclusion criteria: unable to co‐operate with treatment and attend daily therapy for the first 10 working days.
37 female, 11 male; mean age 62 years, range 11 to 85 years |
| Interventions |
Interventions started on average 8.6 days since injury, upon referral to physiotherapy department.
1. Pulsed high frequency electromagnetic field (‘Curapulse’), 30 minutes/day for first 10 working days. (Intensity setting 3, pulse repetition frequency 35, maximum pulse power 300 watts.)
2. Dummy apparatus (deactivated machine)
Assigned: 22/26
Completed (at 6 months): 21/24 |
| Outcomes |
Length of follow‐up: 6 months; also assessed at 1 and 2 months
No data provided in report
Range of movement of glenohumeral & scapulothoracic joints
Pain scores, at rest, on movement, analgesia requirement
Muscle wasting and strength
Overall functional assessment score
Subjective opinion of treatment
Overall estimation of treatment (a ‘good result’)
Time to discharge |
| Funding and conflict of interest statements |
There was no statement on funding.
There was no statement on conflicts of interest. |
| Notes |
All participants received the same standardised physiotherapy regimen.
No data provided in report for comparison between the two interventions. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
No details provided: "patients were randomized into two groups" |
| Allocation concealment (selection bias) |
Low risk |
"[D]ouble‐blind", and randomisation code was only broken at end of the trial period to permit analyses |
| Blinding (performance bias and detection bias)
Functional outcomes, pain, clinical outcomes, complications |
Low risk |
"[D]ouble‐blind", use of sham control |
| Incomplete outcome data (attrition bias)
Functional outcomes, pain, clinical outcomes, complications |
High risk |
Although loss to follow‐up reported, no results were presented for the trial groups |
| Selective reporting (reporting bias) |
High risk |
Results not presented |
| Balance in baseline characteristics? |
Unclear risk |
Baseline comparability. However, although the article claims "patients ... were referred to the physiotherapy department without delay", the ranges for average time from injury to start treatment were 0 to 17 days (active) and 0 to 27 days (sham). |
| Free from performance bias? |
Unclear risk |
"Standardized physiotherapy regimen". However, although the article claims "patients ... were referred to the physiotherapy department without delay", the ranges for average time from injury to start treatment were 0 to 17 days (active) and 0 to 27 days (sham). |