Plain English Summary
Background and study aims
The rotator cuff is a group of muscles and their tendons in the shoulder. Rotator cuff tendinopathy is defined as pain and dysfunction of one or more of those tendons (called supraspinatus, infraspinatus, subscapularis and teres minor). Exercise is the most common and relatively effective treatment . However, although the results are comparable to surgery, not everyone responds positively or completely. There is a definitive need to identify new methods to support current practice and in order to improve outcomes. Nutritional supplements are marketed to people suffering musculoskeletal symptoms, such as joint degeneration and tendinopathy. Omega-3 poly unsaturated fatty acids (PUFAs) have been recommended for people suffering from tendinopathy, with one potential benefit being a reduction in inflammation which may be present in tendinopathy. The aim of this study is to compare exercise and PUFAs to exercise and placebo supplements.
Who can participate?
Adults diagnosed with Rotator cuff tendinopathy.
What does the study involve?
Participants are randomly allocated to one of two groups: exercise and PUFAs group or exercise and dummy supplements group.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
3 sites in London (UK): Guy's and St Thomas' NHS Foundation Trust, St George's Foundation NHS Trust and Health at the Stowe, Westminster PCT / Central London Community Healthcare NHS Trust
When is the study starting and how long is it expected to run for?
June 2008 to December 2012
Who is funding the study?
Seven Seas (UK)
Who is the main contact?
Ms Fiona Sandford
fiona.sandford@kcl.ac.uk
Study website
Contact information
Type
Scientific
Contact name
Mrs Fiona Sandford
ORCID ID
Contact details
Musculoskeletal clinical assessment triage and treatment service (MCATTS)
Physiotherapy Department
St Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom
+44 (0)7836 622076
fiona.sandford@kcl.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A randomised single blinded placebo controlled study investigating the role of poly unsaturated fatty acids in addition to exercise in the management of rotator cuff tendinopathy
Acronym
Study hypothesis
Poly unsaturated fatty acid supplementation will result in significant improvement in disability (as measured by the Oxford Shoulder Score) or the experience of pain when compared to placebo when assessed at 2 months, 3 months, 6 months and one year.
Ethics approval(s)
Main REC: NRES Committee London-Bromley, ref: 08/H0805/21
Study design
Multi-centre interventional randomised placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Rotator cuff tendinopathy
Intervention
The active supplements used in this trial were MaxEPA supplements (Seven Seas Ltd, Hull, UK). They are gelatine coated capsules, oval in shape and brown tan in colour, containing 170mg EPA, 115mg DHA, 100 units/g vitamin E and 10 units/g vitamin D. The placebo supplement looked identical but contained mixed inert oil in place of the EPA and DHA. Participants in both groups were asked to take 9 soft shell capsules per day for a total of 2 months. Both groups also attended an exercise group once a week for a total of 8 weeks.
Intervention type
Supplement
Primary outcome measure
The Oxford shoulder score questionnaire was used at baseline, 2 months, 3 months, 6 months and 12 months.
Secondary outcome measures
1. Numerical rating score for pain
2. Shoulder Pain and Disability Index (SPADI)
3. Patient specific functional score (PSFS): a questionnaire used to quantify activity limitation and measure functional outcome in areas chosen by the patient specifically
4. EuroQol D5-3L (EQ-D5-3L) health questionnaire: a measure of health related quality of life
5. Short Form (SF)-36
6. Global perception of change
7. Range of glenohumeral range of motion (flexion/abduction/internal and external rotation, hand behind back)
8. Shoulder strength (shoulder flexion/abduction/internal and external rotation and biceps strength).
All taken at baseline, 2 months, 3 months, 6 months and 12 months.
Overall study start date
01/06/2008
Overall study end date
12/12/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
The study aimed to recruit men and women aged 18 to 80 years, who were referred for physiotherapy to one of four physiotherapy departments with a diagnosis of unilateral RC tendinopathy.
1. Unilateral shoulder pain of more than 3 months duration (anterior &/or antero-lateral
2. Pain produced or increased during flexion and/or abduction of the symptomatic shoulder
3. Failure of conservative management (manual therapy, exercises, injections, electrotherapy NSAIDS)
4. At least 4 of the following:
4.1 Positive Neer’s impingement sign
4.2 Positive Hawkins & Kennedy test
4.3 Pain & weakness reproduced on full & empty can test
4.4 Pain & weakness on resisted shoulder external rotation
4.5 Pain on palpation over greater tuberosity of humerus
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
72
Total final enrolment
73
Participant exclusion criteria
1. Outside age range of 18-80 years
2. Known allergy to fish or fish products
3. Unwilling to take fish oils
4. Currently taking high dose fish oils (over 1g daily).
5. Diabetes
6. Pregnancy or breast feeding
7. Reproduction of shoulder symptoms during active cervical spine movements
8. Post traumatic onset of symptoms
9. Radiographic or clinical evidence of shoulder instability (sulcus, anterior/posterior draw, relocation test, apprehension test)
Recruitment start date
18/12/2008
Recruitment end date
18/01/2012
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Guy's and St Thomas' Foundation NHS Trust
London
SE1 7EH
United Kingdom
Study participating centre
St George's Foundation NHS Trust
London
SW17 0QT
United Kingdom
Study participating centre
Health at the Stowe, Westminster PCT / Central London Community Healthcare NHS Trust
London
SW1E 6QP
United Kingdom
Sponsor information
Organisation
Guy's and St Thomas' NHS Foundation Trust
Sponsor details
Westminster Bridge Road
London
SE1 7EH
England
United Kingdom
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Industry
Funder name
Seven Seas provided the supplements and placebos
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
St Georges's charitable foundation- medical research
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Stored in repository
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 19/10/2018 | 27/11/2019 | Yes | No |