Exercise in the Physiotherapy Management of Shoulder Impingement (EaSI)

The Effectiveness of Exercise in the Physiotherapy Management of Subacromial Impingement Syndrome

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.

Study Overview

• Status: Unknown
• Conditions: Subacromial Impingement Syndrome
• Intervention / Treatment: Other: Usual physiotherapy without exercise; Other: Evidence based exercise protocol

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.

• Study Type: Interventional
• Enrollment (Anticipated): 94
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Catherine E Hanratty, BSc Hons; Phone Number: 0044 2890 368732; Email: hanratty-c@email.ulster.ac.uk
• Study Contact Backup: Name: Joseph G McVeigh, BSc Hons; Phone Number: 0044 2890 368148; Email: j.mcveigh@ulster.ac.uk

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline in average pain scores at rest and at night using 100mm visual analogue scale (VAS).	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.	Outcomes measured at 0, 6 and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario Rotator Cuff Index (WORC	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.	0, 6 and 12 weeks
The American Shoulder and Elbow Surgeons function score.	Limb specific outcome measure	0. 6 and 12 weeks
SF-36 Health Survey • SF-36 Health Survey	Generic measure of health status	0, 6 and 12 weeks
Isometric strength and range of movement of shoulder flexion, abduction, external rotation and internal rotation using a hand held dynamometer.	objective measures of strength and ROM	0, 6 and 12 weeks

Collaborators and Investigators

• Sponsor: University of Ulster
• Collaborators: Mayo Clinic; Belfast Health and Social Care Trust; Keele University; Northern Health and Social Care Trust
• Investigators: Principal Investigator: Joseph G McVeigh, BSc Hons, University of Ulster

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): May 1, 2013
• Study Completion (Anticipated): May 1, 2013

Study Registration Dates

• First Submitted: August 8, 2012
• First Submitted That Met QC Criteria: September 19, 2012
• First Posted (Estimate): September 24, 2012

Study Record Updates

• Last Update Posted (Estimate): October 12, 2012
• Last Update Submitted That Met QC Criteria: October 11, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Exercise; Physiotherapy; Subacromial impingement syndrome; Rotator cuff
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Joint Diseases; Musculoskeletal Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Syndrome; Rotator Cuff Injuries; Shoulder Impingement Syndrome
• Other Study ID Numbers: 11/NI/0026 version 3.1