Exercise for Subacromial Pain Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Heavy Slow Resistance Exercise for Subacromial Pain Syndrome

Conditions
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Subacromial Pain Syndrome

Intervention / Treatment
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* Diagnostic Test: Different exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Heavy slow resistance exercise<br> | Diagnostic Test: Different exercise<br>* Evaluating the difference between Heavy slow resistance and traditional exercise, based on the SPADI score.<br>|
| Placebo Comparator: Traditional supervised exercise<br> | Diagnostic Test: Different exercise<br>* Evaluating the difference between Heavy slow resistance and traditional exercise, based on the SPADI score.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up. | 
| 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. | Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up. | 
| 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. | Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up. | 
| 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. | Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up. | 
| 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. | Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up. | 
| 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. | Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up. |