A prospective, controlled randomised study investigating functional outcome, with early and late physiotherapy, on patients following a fractured proximal humerus.
| ISRCTN | ISRCTN87732015 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87732015 |
| Protocol serial number | RBF 98X42 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive Trent (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 09/12/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr D Stanley
Scientific
Scientific
Orthopaedics
Northern General Hospital NHS Trust
Herries Road
Sheffield
S5 7AU
United Kingdom
| Phone | +44 (0)114 271 4025 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To examine the functional outcome of patients sustaining a fractured proximal humerus, following early and late physiotherapy. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Injury, occupational diseases, poisoning: Musculoskeletal injury |
| Intervention | 1.. Physiotherapy within one week of their interviews 2. Physiotherapy at three weeks following their injury. Both groups will receive treatment by senior physiotherapists who will be following a physiotherapy protocol for treatment and home exercises. Functional outcome measurements will be taken at three intervals. |
| Intervention type | Other |
| Primary outcome measure(s) |
Outcome measure: SF-36 and C-MSA (Constant-Murley shoulder assessment) |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/04/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 120 |
| Key inclusion criteria | 120 patients sustaining fractured proximal humerus |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/10/1998 |
| Date of final enrolment | 30/04/2001 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Orthopaedics
Sheffield
S5 7AU
United Kingdom
S5 7AU
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2003 | Yes | No | |
| Results article | 2 -year follow-up results | 01/03/2007 | Yes | No |
