Supervised Exercise Therapy vs Home Exercises for Patients With Subacromial Impingement

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01257113

First Posted: December 9, 2010

Last Update Posted: June 23, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Norwegian University of Science and Technology

Purpose

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	Intervention
Shoulder Impingement Syndrome	Other: supervised exercise Other: homebased exercises


Study Type:	Interventional
Study Design:	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?

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Enrollment:	46
Study Start Date:	January 2011
Study Completion Date:	April 2013
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

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.

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01257113

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

Publications:

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 Submitted:	December 8, 2010
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

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