Exercise in the Physiotherapy Management of Shoulder Impingement

NCT01691157 | Unknown DMC

• 1 other identifier: 11/NI/0026 version 3.1
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 4

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.

Conditions

Subacromial Impingement Syndrome

Keywords

Subacromial impingement syndrome; Rotator cuff; Exercise; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Western Ontario Rotator Cuff Index (WORC

  0, 6 and 12 weeks

• The American Shoulder and Elbow Surgeons function score.

  0. 6 and 12 weeks

• SF-36 Health Survey • SF-36 Health Survey

  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.

  0, 6 and 12 weeks

Study Arms (2)

Usual physiotherapy without exercise

ACTIVE COMPARATOR

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

Exercise

EXPERIMENTAL

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

Other: Evidence based exercise protocol

Interventions

Evidence based exercise protocol OTHER

An evidence based graduated exercise rehabilitation protocol will be provided and supervised by a physiotherapist. patients will receive 6 sessions of supervised physiotherapy

Exercise

Usual physiotherapy without exercise OTHER

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.

Also known as: Usual care

Usual physiotherapy without exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Ulster: lead
• Belfast Health and Social Care Trust: collaborator
• Northern Health and Social Care Trust: collaborator
• Mayo Clinic: collaborator
• Keele University: collaborator

Study Sites (4)

Musgrave Park Hospital

Belfast, N.Ireland, BT9 7JB, United Kingdom

RECRUITING

The Waveney Hospital

Ballymena, N.I, United Kingdom

RECRUITING

Robinson Memorial Hospital

Ballymoney, N.I, BT53 6HB, United Kingdom

RECRUITING

The Fort Centre, Physiotherapy Department

Coleraine, N.I, United Kingdom

RECRUITING

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Joseph G McVeigh, BSc Hons

  University of Ulster

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine E Hanratty, BSc Hons

CONTACT

0044 2890 368732; hanratty-c@email.ulster.ac.uk

Joseph G McVeigh, BSc Hons

CONTACT

0044 2890 368148; j.mcveigh@ulster.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Physiotherapy and PhD supervisor

Study Record Dates

• First Submitted: August 8, 2012
• First Posted: September 24, 2012
• Study Start: September 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: October 12, 2012

Record last verified: 2012-10

Locations

GB (4)