A randomized placebo controlled clinical trial of a rehabilitation programme for patients with a diagnosis of massive, irreparable rotator cuff tears of the shoulder

ISRCTN	ISRCTN64734872
DOI	https://doi.org/10.1186/ISRCTN64734872
Secondary identifying numbers	N0620168697

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mrs Roberta Ainsworth
Scientific

Consultant Physiotherapist
Physiotherapy Department
Torbay Hospital
Torquay
TQ2 7AA
United Kingdom

Phone	+44 01803 655340
Email	roberta.ainsworth@nhs.net

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	To investigate the effect of a specific rehabilitation programme for patients with massive tears of the rotator cuff tendons in their shoulder.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Musculoskeletal Diseases: Shoulder disorders
Intervention	Patients will be randomized to receive ultrasound or to receive ultrasound and a rehabilitation program. Patients randomized into the rehabilitation arm of the study will be following the rehabilitation program developed at Torbay hospital.
Intervention type	Other
Primary outcome measure	To use the information collected to improve the rehabilitation programme and to increase awareness of which patient will do well with the programme. Primary outcome measure: Oxford Shoulder Score.
Secondary outcome measures	Not provided at time of registration
Overall study start date	05/09/2005
Completion date	31/08/2008

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	60
Key inclusion criteria	60 patients with a diagnosis of irreparable rotator cuff tears will be recruited from patients referred into the South Devon Physiotherapy Service by GPs, consultants or by self referral, 30 for the exercise group and 30 for the control group. Inclusion criteria: 1. 18 years or over (no upper age limit) 2. Male or female 3. Clinical and ultrasonographic diagnosis of massive rotator cuff tear (full thickness tear of more than 5cm) 4. Diagnosis of massive, irreparable rotator cuff tear following shoulder surgery to try to repair the rotator cuff 5. Patient able to understand and co-operate with research and able to give informed consent 6. Fluent in written and spoken English
Key exclusion criteria	1. Diagnosed neurological abnormality affecting the shoulder joint complex 2. Patients involved in an industrial claim or litigation 3. Patients whose rotator cuff tear is considered to be operable
Date of first enrolment	05/09/2005
Date of final enrolment	31/08/2008

Consultant Physiotherapist

Torquay
TQ2 7AA
United Kingdom

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

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

Government

Exeter Primary Care Trust (UK)

No information available

NHS R&D Support Funding (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	01/09/2006		Yes	No