Exercise in the Physiotherapy Management of Shoulder Impingement

Subacromial Impingement Syndrome Clinical Trial

— EaSI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01691157
• Other study ID #: 11/NI/0026 version 3.1
• Status: Recruiting
• Phase: N/A
• First received: August 8, 2012
• Last updated: October 11, 2012
• Start date: September 2012
• Est. completion date: May 2013

Study information

• Verified date: October 2012
• Source: University of Ulster
• Contact: Catherine E Hanratty, BSc Hons
• Phone: 0044 2890 368732
• Email: hanratty-c[@]email.ulster.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Shoulder Impingement Syndrome
• Subacromial Impingement Syndrome

Intervention

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
• 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.

Locations

Country	Name	City	State
United Kingdom	The Waveney Hospital	Ballymena	N.I
United Kingdom	Robinson Memorial Hospital	Ballymoney	N.I
United Kingdom	Musgrave Park Hospital	Belfast	N.Ireland
United Kingdom	The Fort Centre, Physiotherapy Department	Coleraine	N.I

Sponsors (5)

Lead Sponsor	Collaborator
University of Ulster	Belfast Health and Social Care Trust, Keele University, Mayo Clinic, Northern Health and Social Care Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	The American Shoulder and Elbow Surgeons function score.	Limb specific outcome measure	0. 6 and 12 weeks	No
Secondary	SF-36 Health Survey • SF-36 Health Survey	Generic measure of health status	0, 6 and 12 weeks	No
Secondary	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	No