Clinical trial NCT01691157: Exercise in the Physiotherapy Management of Shoulder Impingement
Official title: The Effectiveness of Exercise in the Physiotherapy Management of Subacromial Impingement Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Subacromial Impingement Syndrome
Keywords: Subacromial impingement syndrome
Rotator cuff
Exercise
Physiotherapy
Lead sponsor: University of Ulster
Sponsor class: OTHER
Collaborators: name: Belfast Health and Social Care Trust
name: Northern Health and Social Care Trust
name: Mayo Clinic
name: Keele University
First posted: 2012-09-24
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: change from baseline in average pain scores at rest and at night using 100mm visual analogue scale (VAS).
timeFrame: Outcomes measured at 0, 6 and 12 weeks
Secondary outcomes:
measure: Western Ontario Rotator Cuff Index (WORC
timeFrame: 0, 6 and 12 weeks
measure: The American Shoulder and Elbow Surgeons function score.
timeFrame: 0. 6 and 12 weeks
measure: SF-36 Health Survey • SF-36 Health Survey
timeFrame: 0, 6 and 12 weeks
measure: Isometric strength and range of movement of shoulder flexion, abduction, external rotation and internal rotation using a hand held dynamometer.
timeFrame: 0, 6 and 12 weeks
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Musgrave Park Hospital
state: N.Ireland
city: Ballymena
country: United Kingdom
facility: The Waveney Hospital
state: N.I
city: Ballymoney
country: United Kingdom
facility: Robinson Memorial Hospital
state: N.I
city: Coleraine
country: United Kingdom
facility: The Fort Centre, Physiotherapy Department
state: N.I
Study officials:
affiliation: University of Ulster
name: Joseph G McVeigh, BSc Hons
role: PRINCIPAL_INVESTIGATOR
References: