Supervised Exercise Therapy vs Home Exercises for Patients With Subacromial Impingement

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The purpose of this study is to determine whether there are any difference between supervised exercise therapy and homebased exercise when looking at pain and function for patients with shoulder pain.

Condition or disease	Intervention/treatment	Phase
Shoulder Impingement Syndrome	Other: supervised exercise; Other: homebased exercises	Not Applicable

Detailed Description:

Shoulder pain is common in the population. Various treatment modalities are used. According to the literature, it is equally good results for home exercises and for guided exercise therapy. The purpose of this study is to look at this again and determine whether there are any difference between supervised exercise therapy and homebased exercise when looking at pain and function for patients with subacromial impingement.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	46 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Is Supervised Exercise Therapy a Better Option Than Home Exercises for Patients With Subacromial Impingement When Looking at Pain and Function?
Study Start Date :	January 2011
Actual Primary Completion Date :	December 2012
Actual Study Completion Date :	April 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: supervised exercise; The group gets 10 supervised exerciseclasses at the physiotherapy clinic in addition to homebased exercises	Other: supervised exercise; This group will receive 10 classes of supervised exercise in the 6 weeks intervention. In this classes the patients will be with a physiotherapist that will adjust their home-exercise program and make sure they do the exercises in a good way. They will receive 4-6 exercises they shall do 3 times with 30 repetitions, 2 times every day. If necessary, they should also do stretching exercises
Experimental: homebased exercises; The group gets 1 supervised exerciseclass before they do all their exercises at home	Other: homebased exercises; This group will receive 1 class of supervised exercise at the beginning of the 6 weeks intervention. In this class the patients will be with a physiotherapist that will put together a home-exercise program and make sure they do the exercises in a good way. They will receive 4-6 exercises they shall do 3 times with 30 repetitions, 2 times every day. If necessary, they should also do stretching exercises

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Pain and function 1 [ Time Frame: Baseline ]
   Shoulder Pain and Disability Index
2. Pain and function 2 [ Time Frame: At 6 weeks ]
   Shoulder Pain and Disability Index
3. Pain and function 3 [ Time Frame: At 6 months ]
   Shoulder Pain and Disability Index

Secondary Outcome Measures :

1. Fear avoidance 1 [ Time Frame: Baseline ]
   Fear-Avoidance Beliefs Questionnaire. Modified version with questions about shoulder instead of back
2. Fear avoidance 2 [ Time Frame: At 6 weeks ]
   Fear-Avoidance Beliefs Questionnaire. Modified version with questions about shoulder instead of back.
3. Quality of life 1 [ Time Frame: Baseline ]
   The Short-Form 36 questionnaire
4. Quality of life 2 [ Time Frame: At 6 weeks ]
   The Short-Form 36 questionnaire
5. Pain the last week [ Time Frame: Baseline and once a week for 6 weeks ]
   Numeric pain rating scale
6. Active range of motion 1 [ Time Frame: Baseline ]
   Abduction, flexion, external rotation and internal rotation measured with inclinometer
7. Active range of motion 2 [ Time Frame: At 6 weeks ]
   Abduction, flexion, external rotation and internal rotation measured with inclinometer
8. Impingement tests 1 [ Time Frame: Baseline ]
   Hawkins test, painful arc test and isometric external rotation test is beeing conducted and scored positive or negative
9. Impingement tests 2 [ Time Frame: At 6 weeks ]
   Hawkins test, painful arc test and isometric external rotation test is beeing conducted and scored positive or negative
10. Work status 1 [ Time Frame: Baseline ]
    Registration of the patients work status
11. Work status 2 [ Time Frame: At 6 weeks ]
    Registration of the patients work status
12. Work status 3 [ Time Frame: At 6 months ]
    Registration of the patients work status
13. Patient satisfaction [ Time Frame: At 6 weeks ]
    2 questions, one question about benefit and one about satisfaction

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Pain in one shoulder
• Had the condition for more than 12 weeks
• Pain at abduction (must be present in some part between 60 and 120 degrees)
• Pain/ weakness in isometric external rotation
• Positive Hawkins test

Exclusion Criteria:

• Instability
• Labral pathology
• Acromioclavicular joint (AC-joint) pathology
• Complete rupture in the rotatorcuff
• Glenohumeral osteoarthritis
• Previously operated on current shoulder
• The pain comes from neck pathology
• Rheumatoid arthritis or other serious physical or mental illness
• Lack of Norwegian language
• Unable to start

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Norway
Tverrfaglig Poliklinikk, rygg-nakke-skulder. Fys.Med. og rehab., St.Olavs Hospital
Trondheim, Norway, 7006

Sponsors and Collaborators

Norwegian University of Science and Technology

Investigators

Principal Investigator:	Ottar Vasseljen, Dr.Philos	Norwegian University of Science and Technology

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Granviken F, Vasseljen O. Home exercises and supervised exercises are similarly effective for people with subacromial impingement: a randomised trial. J Physiother. 2015 Jul;61(3):135-41. doi: 10.1016/j.jphys.2015.05.014. Epub 2015 Jun 18.

Responsible Party:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT01257113 History of Changes
Other Study ID Numbers:	2010/2591
First Posted:	December 9, 2010
Last Update Posted:	June 23, 2015
Last Verified:	June 2015

Keywords provided by Norwegian University of Science and Technology:

shoulder pain; shoulder impingement; rotatorcuff pathology; supervised exercise; homebased exercise

Additional relevant MeSH terms:

Shoulder Impingement Syndrome; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries