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
Secondary identifying numbers	RBF 98X42

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr D Stanley
Scientific

Orthopaedics
Northern General Hospital NHS Trust
Herries Road
Sheffield
S5 7AU
United Kingdom

Phone	+44 (0)114 271 4025

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
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	Outcome measure: SF-36 and C-MSA (Constant-Murley shoulder assessment)
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/10/1998
Completion date	30/04/2001

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	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

Orthopaedics

Sheffield
S5 7AU
United Kingdom

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

NHS Executive Trent (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

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