SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain

Study Overview
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Brief Summary
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Objective: A randomized clinical trial in order to evaluate the efficacy of a specific exercise strategy for patients with subacromial pain. Hypothesis: H1 - The three month specific exercise strategy has a satisfactory effect improving shoulder function and/or shoulder pain. H0 - No difference between the two exercise strategies (specific exercise strategy and active control exercises). Method: Patients attending primary care with subacromial pain are offered participation. If accepted, they will participate in a three month rehabilitation program. The duration of symptoms can vary from 2 weeks and longer. The patients will be randomized to either rehabilitation; the specific exercise strategy or active control exercises. All patients has an equal number of sessions with the physical therapist (PT) to offer similar attention and support with exercise performance. A blinded physical therapist evaluates the following outcomes at baseline and after three-, six and twelve months: Primary outcomes: Constant-Murley shoulder assessment (CM-score). Secondary outcomes; Disabilities of the Arm Shoulder and Hand questionnaire (DASH), different aspects of pain by Visual Analogue Scale (VAS), EuroQol-5D index (EQ-5D) and EuroQol-VAS (EQ-VAS), The Patient Specific functional Scale, and Patients' global impression of change (PGIC). Also sick-leave and return to work will be recorded. All patients are evaluated with a diagnostic ultrasound to reveal the status of the rotator cuff. Additional to the analysis of treatment effect on shoulder function and pain, factors influencing and explaining the CM-score at follow-ups will be analyzed. This study is warranted in order to evaluate if an earlier reported positive effect on shoulder function and pain with the specific exercise strategy, in patients on waiting list for subacromial decompression, can be repeated in the primary care population of patients with subacromial pain. There is no consensus about first-line exercises for patients with subacromial pain, and these positive results on pain and shoulder function need to be reproduced in primary care before they can be recommended and implemented. Further, knowledge about which factors that can be used in prediction rules for patients that will respond to the exercises or needs surgery is lacking.

Detailed Description
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This study will be reopened and will continue the inclusion due to underpowered results. A new application to the Ethical committee was submitted. Approval to reopen this RCT-study was received at 27th of September 2018 (dnr 218/445-32). Additional inclusion of 40 additional patients will start at 1th of November 2018. Data from baseline to 12 months follow-up (as described in protocol) will be collected. Inclusion continued and the last inklusion was completed in February 2020. Data Collection for all follow ups is anticipated to be completed at latest during March the year of 2021.

Official Title
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SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain - a Randomized Clinical Trial

Conditions
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Shoulder Pain, Subacromial Bursitis, Shoulder Impingement Syndrome, Disorder of Rotator Cuff

Intervention / Treatment
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* Other: Specific exercise group
* Other: Control exercise group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 2 weeks of symptom duration Typical history and pain location (C5 dermatome) Three of these four must be positive: Neer impingement sign Hawkins-Kennedy impingement sign Jobe supraspinatus test Patte maneuver Exclusion Criteria: Polyarthritis or fibromyalgia Pathological hyper-laxity or dislocation of the any of the shoulder joints Cervical spine pathology Lack of communication skills that prevent the use of outcome measures Signs in ultrasound of bone spurs i.e. Acromio-Clavicular joint, that will affect the subacromial space

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 67 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Specific exercise group<br>A progressive program of strength-endurance exercises for the rotator cuff and scapula stabilizing muscles combined with mobilization of the joint capsule when needed | Other: Specific exercise group<br>* A program where exercise load is individually adjusted and the exercises progressed during a 3 month period. The 'pain monitoring model' were used to find the individual resistance. Several exercises are performed eccentrically in order to load more. Initially the exercises were PT-tutored every week and then every other week.<br>* Other names: •Posture;|
| Active Comparator: Control exercise group<br>General movements for the neck and shoulder and self-stretching. No progression some addition of exercises during the three month period. | Other: Control exercise group<br>* A program with movements to maintain flexibility in the neck and shoulder muscles. Initially PT-tutored every week and then every other week.<br>* Other names: •Posture;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Constant-Murley shoulder assessment | Measure a combination of self assessed and clinician assessed items; pain, range-of-motion (flexion and abduction), functional positions (hand in neck as well as hand in back), abduction strength. The score is summarized to a maximum of 100 for best available shoulder function. | Baseline and change 3-, 6- and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Euro Qol 5D index (EQ 5D) | Health Related Quality of Life by EuroQol 5 dimensions and index. Measures different items related to heath related quality of life: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. It results in a health-state where an index of 1 is optimal. | Baseline and change 3-, 6- and 12 months | 
| Disabilities of the arm, shoulder and hand | Self-assessment of the ability to performed exemplified activities. 0 indicates a non-affected upper extremity. | Baseline and change 3-, 6- and 12 months | 
| VAS for pain | Self-assessed for pain at rest, in activity and at night if it disturbs sleeping | Baseline and change 3-, 6- and 12 months | 
| Patients Global Impression of Change (PGIC) | The patients are asked to assess change. A scale ranging from getting worse by the intervention to be recovered. | At follow-up: 3-, 6- and 12 months | 
| The Patient Specific functional Scale | Self-selected functional activities to relate efficacy to during follow-ups. | Baseline and change 3-, 6- and 12 months | 
| Euro Qol VAS (EQ VAS) | In EQ VAS the patients assess their health state on a vertical line valued from 0-100. | Baseline and change 3-, 6- and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subacromial pain, Impingement, Exercises, Physical therapy, Primary care