Exercise in the Physiotherapy Management of Shoulder Impingement (EaSI)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by University of Ulster.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Ulster
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
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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 Endpoint Classification: Efficacy Study 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:
Further study details as provided by 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Limb specific outcome measure
- SF-36 Health Survey • SF-36 Health Survey [ Time Frame: 0, 6 and 12 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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) |
| Genders Eligible for Study: | Both |
| 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
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 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by 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 September 26, 2016