search
Back to results

Exercise in the Physiotherapy Management of Shoulder Impingement (EaSI)

Primary Purpose

Subacromial Impingement Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Evidence based exercise protocol
Usual physiotherapy without exercise
Sponsored by
University of Ulster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subacromial Impingement Syndrome focused on measuring Subacromial impingement syndrome, Rotator cuff, Exercise, Physiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Musgrave Park HospitalRecruiting
  • The Waveney HospitalRecruiting
  • Robinson Memorial HospitalRecruiting
  • The Fort Centre, Physiotherapy DepartmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual physiotherapy without exercise

Exercise

Arm Description

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.

Will receive an evidence based exercise protocol but no other physiotherapeutic modalities

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
The American Shoulder and Elbow Surgeons function score.
Limb specific outcome measure
SF-36 Health Survey • SF-36 Health Survey
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.
objective measures of strength and ROM

Full Information

First Posted
August 8, 2012
Last Updated
October 11, 2012
Sponsor
University of Ulster
Collaborators
Belfast Health and Social Care Trust, Northern Health and Social Care Trust, Mayo Clinic, Keele University
search

1. Study Identification

Unique Protocol Identification Number
NCT01691157
Brief Title
Exercise in the Physiotherapy Management of Shoulder Impingement
Acronym
EaSI
Official Title
The Effectiveness of Exercise in the Physiotherapy Management of Subacromial Impingement Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
May 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ulster
Collaborators
Belfast Health and Social Care Trust, Northern Health and Social Care Trust, Mayo Clinic, Keele University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Impingement Syndrome
Keywords
Subacromial impingement syndrome, Rotator cuff, Exercise, Physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual physiotherapy without exercise
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Exercise
Arm Type
Experimental
Arm Description
Will receive an evidence based exercise protocol but no other physiotherapeutic modalities
Intervention Type
Other
Intervention Name(s)
Evidence based exercise protocol
Intervention Description
An evidence based graduated exercise rehabilitation protocol will be provided and supervised by a physiotherapist. patients will receive 6 sessions of supervised physiotherapy
Intervention Type
Other
Intervention Name(s)
Usual physiotherapy without exercise
Other Intervention Name(s)
Usual care
Intervention Description
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.
Primary Outcome Measure Information:
Title
change from baseline in average pain scores at rest and at night using 100mm visual analogue scale (VAS).
Description
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.
Time Frame
Outcomes measured at 0, 6 and 12 weeks
Secondary Outcome Measure Information:
Title
Western Ontario Rotator Cuff Index (WORC
Description
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.
Time Frame
0, 6 and 12 weeks
Title
The American Shoulder and Elbow Surgeons function score.
Description
Limb specific outcome measure
Time Frame
0. 6 and 12 weeks
Title
SF-36 Health Survey • SF-36 Health Survey
Description
Generic measure of health status
Time Frame
0, 6 and 12 weeks
Title
Isometric strength and range of movement of shoulder flexion, abduction, external rotation and internal rotation using a hand held dynamometer.
Description
objective measures of strength and ROM
Time Frame
0, 6 and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine E Hanratty, BSc Hons
Phone
0044 2890 368732
Email
hanratty-c@email.ulster.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph G McVeigh, BSc Hons
Phone
0044 2890 368148
Email
j.mcveigh@ulster.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph G McVeigh, BSc Hons
Organizational Affiliation
University of Ulster
Official's Role
Principal Investigator
Facility Information:
Facility Name
Musgrave Park Hospital
City
Belfast
State/Province
N.Ireland
ZIP/Postal Code
BT9 7JB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingrid Traynor, Physio
Phone
0044289090
Ext
2078
Email
ingrid.traynor@belfasttrust.hscni.net
Facility Name
The Waveney Hospital
City
Ballymena
State/Province
N.I
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colin Brennan, physio
Phone
00442870347853
Email
colin.brennan@hscni.net
Facility Name
Robinson Memorial Hospital
City
Ballymoney
State/Province
N.I
ZIP/Postal Code
BT53 6HB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colin Brennan, Physio
Phone
00442870347853
Email
colin.brennan@northerntrust.hscni.net
Facility Name
The Fort Centre, Physiotherapy Department
City
Coleraine
State/Province
N.I
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colin Brennan, Physio
Phone
00442870347853
Email
colin.brennan@hscni.net

12. IPD Sharing Statement

Learn more about this trial

Exercise in the Physiotherapy Management of Shoulder Impingement

We'll reach out to this number within 24 hrs