Exercise in the Physiotherapy Management of Shoulder Impingement (EaSI)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified October 2012 by Dr Joseph G McVeigh, University of Ulster.
Recruitment status was: Recruiting

Sponsor:

Collaborators:

Belfast Health and Social Care Trust

Northern Health and Social Care Trust

Mayo Clinic

Keele University

Information provided by (Responsible Party):

Dr Joseph G McVeigh, University of Ulster

ClinicalTrials.gov Identifier:

NCT01691157

First received: August 8, 2012

Last updated: October 11, 2012

Last verified: October 2012

History of Changes

Purpose

The purpose of this trial is to investigate the effectiveness of an evidence based exercise program for shoulder impingement. Approximately 1% of adults consult their General Practitioner (GP) with shoulder pain each year, making it the third most common reason for musculoskeletal GP consultations in the UK. A further 50% of these patients are diagnosed with subacromial impingement syndrome (SAIS) (shoulder impingement syndrome) and commonly referred for physiotherapy treatment. This trial aims to compare the effectiveness of an evidence based exercise protocol with usual physiotherapy care.

Condition	Intervention
Subacromial Impingement Syndrome	Other: Evidence based exercise protocol Other: Usual physiotherapy without exercise


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	The Effectiveness of Exercise in the Physiotherapy Management of Subacromial Impingement Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by Dr Joseph G McVeigh, University of Ulster:

Primary Outcome Measures:

change from baseline in average pain scores at rest and at night using 100mm visual analogue scale (VAS). [ Time Frame: Outcomes measured at 0, 6 and 12 weeks ]
Primary outcome measure: Average pain scores at rest and at night for the week prior to measurement will be recorded using a 100mm visual analogue scale (VAS). The change in pain scores at 6 and 12 weeks from baseline will be measured.

Secondary Outcome Measures:

Western Ontario Rotator Cuff Index (WORC [ Time Frame: 0, 6 and 12 weeks ]
Secondary outcome measures will focus on function, disability and quality of life, consisting of a combination of generic, region specific and disease-specific health questionnaires. The change in scores from baseline will be measured.
The American Shoulder and Elbow Surgeons function score. [ Time Frame: 0. 6 and 12 weeks ]
Limb specific outcome measure
SF-36 Health Survey • SF-36 Health Survey [ Time Frame: 0, 6 and 12 weeks ]
Generic measure of health status
Isometric strength and range of movement of shoulder flexion, abduction, external rotation and internal rotation using a hand held dynamometer. [ Time Frame: 0, 6 and 12 weeks ]
objective measures of strength and ROM


Estimated Enrollment:	94
Study Start Date:	September 2012
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Usual physiotherapy without exercise Will receive 6 sessions of modified usual physiotherapy care that can consist of any physiotherapeutic modalities normally provided except exercise. this may consist of postural advice, taping, electrotherapy, acupuncture, manual joint mobilizations of the shoulder, cervical or thoracic spine.	Other: Usual physiotherapy without exercise Will receive modified usual physiotherapy care that can consist of any physiotherapeutic modalities normally provided except exercise. this may consist of postural advice, taping, electrotherapy, acupuncture, manual joint mobilizations of the shoulder, cervical or thoracic spine. Other Name: Usual care
Experimental: Exercise Will receive an evidence based exercise protocol but no other physiotherapeutic modalities	Other: Evidence based exercise protocol An evidence based graduated exercise rehabilitation protocol will be provided and supervised by a physiotherapist. patients will receive 6 sessions of supervised physiotherapy

Detailed Description:

Physiotherapy management of shoulder impingement frequently involves exercise, however there is little evidence underpinning exercise prescription and outcomes are poor. Few trials have investigated which muscles should be targeted and how they should be strengthened with respect to the mode, frequency, duration, intensity and progression. This is a randomized controlled trial(RCT) investigating the effectiveness of an evidence based exercise program for shoulder impingement. This research may have an impact on how physiotherapists provide exercise programs to patients with shoulder impingement.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must be aged 18 years and older.
Shoulder pain of at least 3/10 in severity that has been diagnosed by a consultant rheumatologist, orthopaedic surgeon or general practitioner within the past 12 months.
Positive Hawkins-Kennedy test.
Positive on testing either supraspinatus (empty can test) or infraspinatus (resisted external rotation in neutral).

Exclusion Criteria:

Acute traumatic conditions.
Evidence of rotator cuff tear (positive drop arm test) or any other shoulder joint pathology (e.g. adhesive capsulitis, labral tears).
A history of fractures of the upper arm, shoulder or clavicle within the past two years.
A history of dislocation of the shoulder within the previous two years.
Postoperative conditions involving the upper arm, shoulder or clavicle.
Inflammatory or systemic diseases.
Current signs and symptoms of acute nerve root pain arising from the cervical or upper thoracic spine.
Previous physiotherapy for the same condition involving an exercise regime.
Previous corticosteroid injection of the affected shoulder within the past 6 months.
Unwilling participant.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01691157

Contacts


Contact: Catherine E Hanratty, BSc Hons	0044 2890 368732	hanratty-c@email.ulster.ac.uk
Contact: Joseph G McVeigh, BSc Hons	0044 2890 368148	j.mcveigh@ulster.ac.uk

Locations


United Kingdom
Musgrave Park Hospital	Recruiting
Belfast, N.Ireland, United Kingdom, BT9 7JB
Contact: Ingrid Traynor, Physio 0044289090 ext 2078 ingrid.traynor@belfasttrust.hscni.net
The Waveney Hospital	Recruiting
Ballymena, N.I, United Kingdom
Contact: Colin Brennan, physio 00442870347853 colin.brennan@hscni.net
Robinson Memorial Hospital	Recruiting
Ballymoney, N.I, United Kingdom, BT53 6HB
Contact: Colin Brennan, Physio 00442870347853 colin.brennan@northerntrust.hscni.net
The Fort Centre, Physiotherapy Department	Recruiting
Coleraine, N.I, United Kingdom
Contact: Colin Brennan, Physio 00442870347853 colin.brennan@hscni.net

Sponsors and Collaborators

University of Ulster

Belfast Health and Social Care Trust

Northern Health and Social Care Trust

Mayo Clinic

Keele University

Investigators


Principal Investigator:	Joseph G McVeigh, BSc Hons	University of Ulster

More Information


Responsible Party:	Dr Joseph G McVeigh, Lecturer in Physiotherapy and PhD supervisor, University of Ulster
ClinicalTrials.gov Identifier:	NCT01691157 History of Changes
Other Study ID Numbers:	11/NI/0026 version 3.1
Study First Received:	August 8, 2012
Last Updated:	October 11, 2012

Keywords provided by Dr Joseph G McVeigh, University of Ulster:


Subacromial impingement syndrome Rotator cuff Exercise Physiotherapy

Additional relevant MeSH terms:


Syndrome Shoulder Impingement Syndrome Disease	Pathologic Processes Joint Diseases Musculoskeletal Diseases

ClinicalTrials.gov processed this record on June 21, 2017

To Top