Condition category
Musculoskeletal Diseases
Date applied
03/06/2015
Date assigned
05/06/2015
Last edited
04/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Hospitals

Trial 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

Phase

Drug names

Primary outcome measures

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 trial start date

01/06/2008

Overall trial end date

12/12/2012

Reason abandoned

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

Patient

Age group

Adult

Gender

Both

Target number of participants

72

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

United Kingdom

Trial participating centre

Guy's and St Thomas' Foundation NHS Trust
London
SE1 7EH
United Kingdom

Trial participating centre

St George's Foundation NHS Trust
London
SW17 0QT
United Kingdom

Trial 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
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes