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Exercise in the Physiotherapy Management of Shoulder Impingement (EaSI)

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ClinicalTrials.gov Identifier: NCT01691157
Recruitment Status : Unknown
Verified October 2012 by Dr Joseph G McVeigh, University of Ulster.
Recruitment status was:  Recruiting
First Posted : September 24, 2012
Last Update Posted : October 12, 2012
Sponsor:
Collaborators:
Belfast Health and Social Care Trust
Northern Health and Social Care Trust
Mayo Clinic
Keele University
Information provided by (Responsible Party):
Dr Joseph G McVeigh, University of Ulster

August 8, 2012
September 24, 2012
October 12, 2012
September 2012
May 2013   (Final data collection date for primary outcome measure)
change from baseline in average pain scores at rest and at night using 100mm visual analogue scale (VAS). [ Time Frame: Outcomes measured at 0, 6 and 12 weeks ]
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.
Same as current
Complete list of historical versions of study NCT01691157 on ClinicalTrials.gov Archive Site
  • Western Ontario Rotator Cuff Index (WORC [ Time Frame: 0, 6 and 12 weeks ]
    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. [ Time Frame: 0. 6 and 12 weeks ]
    Limb specific outcome measure
  • SF-36 Health Survey • SF-36 Health Survey [ Time Frame: 0, 6 and 12 weeks ]
    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. [ Time Frame: 0, 6 and 12 weeks ]
    objective measures of strength and ROM
Same as current
Not Provided
Not Provided
 
Exercise in the Physiotherapy Management of Shoulder Impingement
The Effectiveness of Exercise in the Physiotherapy Management of Subacromial Impingement Syndrome
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Subacromial Impingement Syndrome
  • 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
  • Other: 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.
    Other Name: Usual care
  • Active Comparator: Usual physiotherapy without exercise
    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.
    Intervention: Other: Usual physiotherapy without exercise
  • Experimental: Exercise
    Will receive an evidence based exercise protocol but no other physiotherapeutic modalities
    Intervention: Other: Evidence based exercise protocol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
94
Same as current
May 2013
May 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01691157
11/NI/0026 version 3.1
Yes
Not Provided
Not Provided
Dr Joseph G McVeigh, University of Ulster
University of Ulster
  • Belfast Health and Social Care Trust
  • Northern Health and Social Care Trust
  • Mayo Clinic
  • Keele University
Principal Investigator: Joseph G McVeigh, BSc Hons University of Ulster
University of Ulster
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP