ISRCTN ISRCTN76701121
DOI https://doi.org/10.1186/ISRCTN76701121
Secondary identifying numbers N0155182845
Submission date
28/09/2007
Registration date
28/09/2007
Last edited
23/04/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
The rotator cuff tendon is a cord connecting the muscles in your shoulder to the top of your arm. In shoulder impingement syndrome, the rotator cuff tendon becomes trapped and scrapes against the bone above, causing pain. The main recommended treatment is to use exercise to strengthen the rotator cuff muscles. The aim of this study was to compare the effects of three different exercise programmes.

Who can participate?
Patients who had shown signs of shoulder impingement syndrome for at least 3 months.

What does the study involve?
Participants were randomly allocated to one of the three different exercise programmes for 6 weeks. Participants were advised to exercise twice per day and keep a diary, and completed questionnaires to assess changes in pain and disability at the start and end of the study.

What are the possible benefits and risks of participating?
The results of this study will help us to develop more efficient exercise programmes that will speed up recovery and treatment for shoulder impingement syndrome. A few participants experienced some pain when exercising.

Where is the study run from?
North Manchester General Hospital (UK).

When is the study starting and how long is it expected to run for?
From October 2005 to October 2009.

Who is funding the study?
North Manchester General Hospital (UK).

Who is the main contact?
Stuart Heron
stuart.heron@pat.nhs.uk

Contact information

Mr Stuart Heron
Scientific

North Manchester General Hospital
Delaunays Road
Crumpsall
Manchester
M8 5RB
United Kingdom

Phone +44 (0)161 720 2423
Email stuart.heron@pat.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet'
Scientific titleExercise therapy for shoulder impingement syndrome
Study objectivesTo determine the effectiveness of 3 different exercise programmes used to treat chronic shoulder impingement syndrome?
Ethics approval(s)North Manchester LREC (UK), 14/11/2005, ref: 05/Q1406/90
Health condition(s) or problem(s) studiedMusculoskeletal Diseases: Shoulder pain
InterventionThe intervention arms are three different exercise programmes: open kinetic chain strengthening, closed kinetic chain strengthening and range of motion.
Intervention typeBehavioural
Primary outcome measureEffectiveness in reduction of shoulder impingement. Primary outcome measures are shoulder pain and disability index.
Secondary outcome measures1. EuroQol Visual analogue scores
2. Exercise diary sheets
3. Perceived treatment efficacy
Overall study start date31/10/2005
Completion date31/10/2009

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants169
Key inclusion criteriaPatients with chronic shoulder impingement syndrome (longer than 3 months)
Key exclusion criteria1. Shoulder pain of less than 3 months' duration
2. Cervical radiculopathy
3. Reduced passive glenohumeral joint range
4. Inflammatory arthritis
5. Known psychiatric disorder
6. Known neurological condition
Date of first enrolment31/10/2005
Date of final enrolment31/10/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

North Manchester General Hospital
Manchester
M8 5RB
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

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

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Pennine Acute Hospitals NHS Trust (UK), NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Abstract results No No
Results article 01/06/2017 23/04/2021 Yes No

Editorial Notes

23/04/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.