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Supervised Exercise Therapy vs Home Exercises for Patients With Subacromial Impingement

Primary Purpose

Shoulder Impingement Syndrome

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
supervised exercise
homebased exercises
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Impingement Syndrome focused on measuring shoulder pain, shoulder impingement, rotatorcuff pathology, supervised exercise, homebased exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tverrfaglig Poliklinikk, rygg-nakke-skulder. Fys.Med. og rehab., St.Olavs Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

supervised exercise

homebased exercises

Arm Description

The group gets 10 supervised exerciseclasses at the physiotherapy clinic in addition to homebased exercises

The group gets 1 supervised exerciseclass before they do all their exercises at home

Outcomes

Primary Outcome Measures

Pain and function 1
Shoulder Pain and Disability Index
Pain and function 2
Shoulder Pain and Disability Index
Pain and function 3
Shoulder Pain and Disability Index

Secondary Outcome Measures

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

Full Information

First Posted
December 8, 2010
Last Updated
November 20, 2019
Sponsor
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT01257113
Brief Title
Supervised Exercise Therapy vs Home Exercises for Patients With Subacromial Impingement
Official Title
Is Supervised Exercise Therapy a Better Option Than Home Exercises for Patients With Subacromial Impingement When Looking at Pain and Function?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement Syndrome
Keywords
shoulder pain, shoulder impingement, rotatorcuff pathology, supervised exercise, homebased exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
supervised exercise
Arm Type
Experimental
Arm Description
The group gets 10 supervised exerciseclasses at the physiotherapy clinic in addition to homebased exercises
Arm Title
homebased exercises
Arm Type
Experimental
Arm Description
The group gets 1 supervised exerciseclass before they do all their exercises at home
Intervention Type
Other
Intervention Name(s)
supervised exercise
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
homebased exercises
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain and function 1
Description
Shoulder Pain and Disability Index
Time Frame
Baseline
Title
Pain and function 2
Description
Shoulder Pain and Disability Index
Time Frame
At 6 weeks
Title
Pain and function 3
Description
Shoulder Pain and Disability Index
Time Frame
At 6 months
Secondary Outcome Measure Information:
Title
Fear avoidance 1
Description
Fear-Avoidance Beliefs Questionnaire. Modified version with questions about shoulder instead of back
Time Frame
Baseline
Title
Fear avoidance 2
Description
Fear-Avoidance Beliefs Questionnaire. Modified version with questions about shoulder instead of back.
Time Frame
At 6 weeks
Title
Quality of life 1
Description
The Short-Form 36 questionnaire
Time Frame
Baseline
Title
Quality of life 2
Description
The Short-Form 36 questionnaire
Time Frame
At 6 weeks
Title
Pain the last week
Description
Numeric pain rating scale
Time Frame
Baseline and once a week for 6 weeks
Title
Active range of motion 1
Description
Abduction, flexion, external rotation and internal rotation measured with inclinometer
Time Frame
Baseline
Title
Active range of motion 2
Description
Abduction, flexion, external rotation and internal rotation measured with inclinometer
Time Frame
At 6 weeks
Title
Impingement tests 1
Description
Hawkins test, painful arc test and isometric external rotation test is beeing conducted and scored positive or negative
Time Frame
Baseline
Title
Impingement tests 2
Description
Hawkins test, painful arc test and isometric external rotation test is beeing conducted and scored positive or negative
Time Frame
At 6 weeks
Title
Work status 1
Description
Registration of the patients work status
Time Frame
Baseline
Title
Work status 2
Description
Registration of the patients work status
Time Frame
At 6 weeks
Title
Work status 3
Description
Registration of the patients work status
Time Frame
At 6 months
Title
Patient satisfaction
Description
2 questions, one question about benefit and one about satisfaction
Time Frame
At 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ottar Vasseljen, Dr.Philos
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tverrfaglig Poliklinikk, rygg-nakke-skulder. Fys.Med. og rehab., St.Olavs Hospital
City
Trondheim
ZIP/Postal Code
7006
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
26093810
Citation
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.
Results Reference
result

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Supervised Exercise Therapy vs Home Exercises for Patients With Subacromial Impingement

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