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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01691157
Other study ID # 11/NI/0026 version 3.1
Secondary ID
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


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
See also
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