Condition category
Musculoskeletal Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
28/03/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17042025

Publication citations

  1. 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.

Additional files

Editorial Notes