Condition category
Musculoskeletal Diseases
Date applied
01/01/2014
Date assigned
11/03/2014
Last edited
11/03/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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 Vincent’s 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

Trial website

Contact information

Type

Scientific

Primary contact

Mr Micheal Bailey

ORCID ID

Contact details

Physiotherapy Department
St Vincents University Hospital
Elm Park
Dublin
4
Ireland
m.bailey@svuh.ie

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effect of an eccentric training program on patients clinically diagnosed with chronic unilateral rotator cuff tendinopathy

Acronym

Study hypothesis

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

Ethical Committee of St Vincent's University Hospital, 09/09/2013

Study design

Single blind randomized 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

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

Phase

Not Applicable

Drug names

Primary outcome measures

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. Patient’s perceived improvement - Global Rating of Change Scale assessed at 6 weeks and 12 weeks
3. Pain - VAS assessed at baseline and end point

Overall trial start date

16/12/2013

Overall trial end date

31/07/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

54 participants in each group. There will be two groups.

Participant 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

Recruitment start date

16/12/2013

Recruitment end date

31/07/2014

Locations

Countries of recruitment

Ireland

Trial participating centre

Physiotherapy Department
Dublin
4
Ireland

Sponsor information

Organisation

University College Dublin (Ireland)

Sponsor details

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

Sponsor type

University/education

Website

http://www.ucd.ie/

Funders

Funder type

Other

Funder name

Investigator initiated and funded (Ireland)

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

Publication citations

Additional files

Editorial Notes