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Supervised Exercise Therapy vs Home Exercises for Patients With Subacromial Impingement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01257113
First received: December 8, 2010
Last updated: June 22, 2015
Last verified: June 2015
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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:

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 ] [ Designated as safety issue: No ]
    Shoulder Pain and Disability Index

  • Pain and function 2 [ Time Frame: At 6 weeks ] [ Designated as safety issue: No ]
    Shoulder Pain and Disability Index

  • Pain and function 3 [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
    Shoulder Pain and Disability Index


Secondary Outcome Measures:
  • Fear avoidance 1 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Fear-Avoidance Beliefs Questionnaire. Modified version with questions about shoulder instead of back

  • Fear avoidance 2 [ Time Frame: At 6 weeks ] [ Designated as safety issue: No ]
    Fear-Avoidance Beliefs Questionnaire. Modified version with questions about shoulder instead of back.

  • Quality of life 1 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The Short-Form 36 questionnaire

  • Quality of life 2 [ Time Frame: At 6 weeks ] [ Designated as safety issue: No ]
    The Short-Form 36 questionnaire

  • Pain the last week [ Time Frame: Baseline and once a week for 6 weeks ] [ Designated as safety issue: No ]
    Numeric pain rating scale

  • Active range of motion 1 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Abduction, flexion, external rotation and internal rotation measured with inclinometer

  • Active range of motion 2 [ Time Frame: At 6 weeks ] [ Designated as safety issue: No ]
    Abduction, flexion, external rotation and internal rotation measured with inclinometer

  • Impingement tests 1 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Hawkins test, painful arc test and isometric external rotation test is beeing conducted and scored positive or negative

  • Work status 1 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Registration of the patients work status

  • Work status 2 [ Time Frame: At 6 weeks ] [ Designated as safety issue: No ]
    Registration of the patients work status

  • Work status 3 [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
    Registration of the patients work status

  • Patient satisfaction [ Time Frame: At 6 weeks ] [ Designated as safety issue: No ]
    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

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
Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01257113     History of Changes
Other Study ID Numbers: 2010/2591 
Study First Received: December 8, 2010
Last Updated: June 22, 2015
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

ClinicalTrials.gov processed this record on September 23, 2016