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 measure
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 (if study stopped)
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
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
Basic results (scientific)