The effect of an eccentric exercise program on patients with shoulder pain and disability, which is caused by dysfunction of the rotator cuff

ISRCTN	ISRCTN78361279
DOI	https://doi.org/10.1186/ISRCTN78361279
Secondary identifying numbers	N/A

Submission date: 01/01/2014
Registration date: 11/03/2014
Last edited: 11/03/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Shoulder pain is a very common complaint. Shoulder pain and stiffness has major effects on the use of healthcare resources and work-related costs. Exercise has been shown to help with many conditions, including tendinopathy. Tendinopathy is a term used to describe symptoms arising from a tendon (a tissue that connects muscle to bone). This study aims to find out the effect of a particular type of exercise on patients suffering from rotator cuff tendinopathy. This exercise is an eccentric exercise. Eccentric exercise is the lowering phase of an exercise, where your muscles are paying out, rather than contracting.

Who can participate?
Adult patients suffering from tendon-related shoulder pain can participate in this study.

What does the study involve?
Following assessment eligible patients who agree to participate will be randomly allocated to one of two groups. One of the groups will be treated using an eccentric exercise program, which will be demonstrated to them and conducted by the physiotherapist. They will also receive general advice. The other group will receive traditional physiotherapy treatment, including other forms of exercise and manual treatment techniques. All participants will be asked to complete various questionnaires at the beginning of the study, and at 6 and 12 weeks into their treatment .

What are the possible benefits and risks of participating?
Patients will not benefit directly from taking part in this study but the information we get may provide further knowledge about managing this condition. Participation in this study should be as safe as normal physiotherapy treatment.

Where is the study run from?
The study will be run from the Physiotherapy Department of St Vincents University Hospital,
Dublin, Ireland.

When is study starting and how long is it expected to run for?
The study is expected to run from December 2013 until July 2014.

Who is funding the study?
Investigator initiated and funded (Ireland).

Who is the main contact?
Mr Micheal Bailey
mibailey83@gmail.com

Contact information

Mr Micheal Bailey
Scientific

Physiotherapy Department
St Vincents University Hospital
Elm Park
Dublin
4
Ireland

Email	m.bailey@svuh.ie

Study information

Study design	Single blind randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The effect of an eccentric training program on patients clinically diagnosed with chronic unilateral rotator cuff tendinopathy
Study objectives	Tendinopathy is a generic term used to describe pathology in and pain arising from a tendon; it is associated with failed healing response, in this study we will be examining tendinopathy in relation to the rotator cuff tendons of the shoulder. The aim of this study is to evaluate the effectiveness of a structured eccentric exercise program in the management of patients suffering from unilateral shoulder pain where rotator cuff tendinopathy is seen as the primary cause when compared with regular treatment.
Ethics approval(s)	Ethical Committee of St Vincent's University Hospital, 09/09/2013
Health condition(s) or problem(s) studied	Rotator Cuff Tendinopathy
Intervention	Conservative management of rotator cuff tendinopathy using eccentric exercise. Patients will complete 15 repetitions in three sets of each exercise twice a day. There are three exercises to complete. Patients will be provided with written and pictorial references as to the correct technique of these exercises and guided by the physiotherapist. The control group will be treated with traditional physiotherapy intervention, excluding the above eccentric exercise program. The duration of each participants involvement in the study will be 12 weeks. Measures will be taken at baseline, 6 weeks, and 12 weeks.
Intervention type	Other
Primary outcome measure	1. Pain and Disability - SPADI 2. Health Related Quality of Life - EuroQol EQ 5D Outcomes measured at baseline, 6 weeks and 12 weeks
Secondary outcome measures	1. Shoulder Range of Motion - Goniometry assessed at baseline and end point 2. Patients perceived improvement - Global Rating of Change Scale assessed at 6 weeks and 12 weeks 3. Pain - VAS assessed at baseline and end point
Overall study start date	16/12/2013
Completion date	31/07/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	54 participants in each group. There will be two groups.
Key inclusion criteria	1. Consent to participate 2. Male and female aged from 18 65 3. Sufficient range of motion (ROM) and function of non-affected shoulder ability to perform exercises 4. Shoulder pain which distributes pain over C4/5 dermatome 5. Passive range of shoulder movement which is greater than active range of movement 6. Pain which is reduced by rest 7. Pain on resisted external rotation or pain on resisted abduction 8. Symptom duration equal to or greater than 12 weeks
Key exclusion criteria	1. Recent shoulder/upper arm surgery 2. Recent shoulder or upper arm fracture 3. Recent shoulder dislocation 4. Symptoms aggravated by C-Spine range of movement 5. Severe resting pain 6. Signs of systemic/rheumatologic cause of symptoms 7. Obvious signs of cognitive impairment 8. Inability to understand written or spoken English 9. Bilateral symptoms which will impair participation in eccentric program 10. Positive Drop Arm
Date of first enrolment	16/12/2013
Date of final enrolment	31/07/2014

Locations

Countries of recruitment

Ireland

Study participating centre

Physiotherapy Department

Dublin
4
Ireland

Sponsor information

University College Dublin (Ireland)
University/education

c/o Dr Cliona O Sullivan
School of Public Health, Physio & Pop Sc
Health Sciences Centre
Belfield
Dublin
4
Ireland

Website	http://www.ucd.ie/
"ROR"	https://ror.org/05m7pjf47

Funders

Funder type

Other

Investigator initiated and funded (Ireland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan