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Exercise in the Physiotherapy Management of Shoulder Impingement (EaSI)

This study is currently recruiting participants.
Verified October 2012 by University of Ulster
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
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:

U.S. FDA Resources

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
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
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

No publications provided

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:
Shoulder Impingement Syndrome
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 16, 2013