Contact information
Type
Scientific
Primary contact
Mrs Roberta Ainsworth
ORCID ID
Contact details
Consultant Physiotherapist
Physiotherapy Department
Torbay Hospital
Torquay
TQ2 7AA
United Kingdom
+44 01803 655340
roberta.ainsworth@nhs.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0620168697
Study information
Scientific title
Acronym
Study hypothesis
To investigate the effect of a specific rehabilitation programme for patients with massive tears of the rotator cuff tendons in their shoulder.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
05/09/2005
Overall trial end date
31/08/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant 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
Recruitment start date
05/09/2005
Recruitment end date
31/08/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Consultant Physiotherapist
Torquay
TQ2 7AA
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Exeter Primary Care Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17042025
Publication citations
-
Results
Ainsworth R, Physiotherapy rehabilitation in patients with massive, irreparable rotator cuff tears., Musculoskeletal Care, 2006, 4, 3, 140-151, doi: 10.1002/msc.85.