Condition category
Musculoskeletal Diseases
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
13/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Mr Stuart Heron

ORCID ID

Contact details

North Manchester General Hospital
Delaunays Road
Crumpsall
Manchester
M8 5RB
United Kingdom
+44 (0)161 720 2423
stuart.heron@pat.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0155182845

Study information

Scientific title

Exercise therapy for shoulder impingement syndrome

Acronym

Study hypothesis

To determine the effectiveness of 3 different exercise programmes used to treat chronic shoulder impingement syndrome?

Ethics approval

North Manchester LREC (UK), 14/11/2005, ref: 05/Q1406/90

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

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 pain

Intervention

The intervention arms are three different exercise programmes: open kinetic chain strengthening, closed kinetic chain strengthening and range of motion.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Effectiveness in reduction of shoulder impingement. Primary outcome measures are shoulder pain and disability index.

Secondary outcome measures

1. EuroQol Visual analogue scores
2. Exercise diary sheets
3. Perceived treatment efficacy

Overall trial start date

31/10/2005

Overall trial end date

31/10/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with chronic shoulder impingement syndrome (longer than 3 months)

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

169

Participant exclusion criteria

1. 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

Recruitment start date

31/10/2005

Recruitment end date

31/10/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

North Manchester General Hospital
Manchester
M8 5RB
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 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

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

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

2011 results in: http://www.abstractstosubmit.com/wpt2011/abstracts/main.php?do=YToyOntzOjU6Im1vZHVsIjtzOjY6ImRldGFpbCI7czo4OiJkb2N1bWVudCI7aTo4OTQ7fQ==&psArchive=aq1e7prcbderv3grm66ri8d562

Publication citations

Additional files

Editorial Notes