Back to resultsExercise for Subacromial Pain Syndrome
Primary Purpose
Subacromial Pain Syndrome
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Different exercise
Sponsored by
About this trial
This is an interventional treatment trial for Subacromial Pain Syndrome
Eligibility Criteria
Inclusion Criteria:
- Shoulder pain > Three months
- Subacromial pain
- Dysfunction or pain during abduction
- Pain during isometric strength test of abduction or external rotation of the shoulder.
- Positive Hawkins test
- Normal passive range of movement in the glenohumeral joint
Exclusion Criteria:
- Surgery of the affected shoulder
- Patients that are not considered suitable to complete the treatment, or able to answer a Norwegian questionnaire
- Shoulder dislocation or shoulder instability
- Clinical sign of cervical nerve root affection
- Rheumatoid arthritis
- Clinical sign of full rupture of the rotator cuff.
- Pregnancy
- Cortisone injection past six weeks
Sites / Locations
- Ullevål Sykehus
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Heavy slow resistance exercise
Traditional supervised exercise
Arm Description
Outcomes
Primary Outcome Measures
Change from Baseline SPADI score at 12- and 24 weeks.
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. Both dimensions account for 50% of the overall score, and scores from 0 to 100.
Secondary Outcome Measures
Change from Baseline "Pain in rest last week" score at 12- and 24 weeks.
11 point Likert-type scale, 0 =no pain, 10 = worst possible pain. Measured by marking a clean visual analogue scale, and later transferred to a score.
Change from Baseline "Pain in activity last week" score at 12- and 24 weeks.
11 point Likert-type scale, 0 =no pain, 10 = worst possible pain. Measured by marking a clean visual analogue scale, and later transferred to a score.
Change From Baseline "The ability to carry a 5kg carry bag" score at 12- and 24 weeks.
11 point Likert-type scale, 0 = no problem, 10 = impossible. Measured by marking a clean visual analogue scale, and later transferred to a score.
Change from Baseline DASH score at 12- and 24 weeks.
DISABILITIES OF THE ARM, SHOULDER AND HAND (DASH) is a 30 points questionnaire about the disability of the shoulder. Answers from 0 to 5; 0 0 No problem completing the activity, 5 = Impossible to complete the activity. Total score is calculated by a summary of the scores, subtracted by 30 and divided by 1.2.
Change from Baseline Active range of motion of the shoulder at 12- and 24 weeks.
A total score the flection, abduction and external rotation of the shoulder. Measured by goniometer.
Change from "The ability to take something down from a high shelf" score at 12- and 24 weeks.
11 point Likert-type scale, 0 = no problem, 10 = impossible. Measured by marking a clean visual analogue scale, and later transferred to a score.
Full Information
NCT ID
NCT03317808
First Posted
October 15, 2017
Last Updated
January 23, 2019
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03317808
Brief Title
Exercise for Subacromial Pain Syndrome
Official Title
Heavy Slow Resistance Exercise for Subacromial Pain Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 16, 2017 (Actual)
Primary Completion Date
December 13, 2018 (Actual)
Study Completion Date
December 13, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the effect of Heavy Slow Resistance exercise (HSR) exercise in comparison with traditional supervised exercise as treatment for patients with subacromial shoulder pain. The purpose is to evaluate if HSR is feasible fir these patients, and compare its effect to traditional exercise at pain and function of the shoulder. One half will complete the heavy slow resistance exercise, the other will complete the conventional exercise.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Pain Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Heavy slow resistance exercise
Arm Type
Active Comparator
Arm Title
Traditional supervised exercise
Arm Type
Placebo Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
Different exercise
Intervention Description
Evaluating the difference between Heavy slow resistance and traditional exercise, based on the SPADI score.
Primary Outcome Measure Information:
Title
Change from Baseline SPADI score at 12- and 24 weeks.
Description
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. Both dimensions account for 50% of the overall score, and scores from 0 to 100.
Time Frame
Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up.
Secondary Outcome Measure Information:
Title
Change from Baseline "Pain in rest last week" score at 12- and 24 weeks.
Description
11 point Likert-type scale, 0 =no pain, 10 = worst possible pain. Measured by marking a clean visual analogue scale, and later transferred to a score.
Time Frame
Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up.
Title
Change from Baseline "Pain in activity last week" score at 12- and 24 weeks.
Description
11 point Likert-type scale, 0 =no pain, 10 = worst possible pain. Measured by marking a clean visual analogue scale, and later transferred to a score.
Time Frame
Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up.
Title
Change From Baseline "The ability to carry a 5kg carry bag" score at 12- and 24 weeks.
Description
11 point Likert-type scale, 0 = no problem, 10 = impossible. Measured by marking a clean visual analogue scale, and later transferred to a score.
Time Frame
Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up.
Title
Change from Baseline DASH score at 12- and 24 weeks.
Description
DISABILITIES OF THE ARM, SHOULDER AND HAND (DASH) is a 30 points questionnaire about the disability of the shoulder. Answers from 0 to 5; 0 0 No problem completing the activity, 5 = Impossible to complete the activity. Total score is calculated by a summary of the scores, subtracted by 30 and divided by 1.2.
Time Frame
Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up.
Title
Change from Baseline Active range of motion of the shoulder at 12- and 24 weeks.
Description
A total score the flection, abduction and external rotation of the shoulder. Measured by goniometer.
Time Frame
Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up.
Title
Change from "The ability to take something down from a high shelf" score at 12- and 24 weeks.
Description
11 point Likert-type scale, 0 = no problem, 10 = impossible. Measured by marking a clean visual analogue scale, and later transferred to a score.
Time Frame
Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Shoulder pain > Three months
Subacromial pain
Dysfunction or pain during abduction
Pain during isometric strength test of abduction or external rotation of the shoulder.
Positive Hawkins test
Normal passive range of movement in the glenohumeral joint
Exclusion Criteria:
Surgery of the affected shoulder
Patients that are not considered suitable to complete the treatment, or able to answer a Norwegian questionnaire
Shoulder dislocation or shoulder instability
Clinical sign of cervical nerve root affection
Rheumatoid arthritis
Clinical sign of full rupture of the rotator cuff.
Pregnancy
Cortisone injection past six weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Høiland
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ullevål Sykehus
City
Oslo
ZIP/Postal Code
0450 Oslo
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Exercise for Subacromial Pain Syndrome
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