SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain (SWESS)
Primary Purpose
Shoulder Pain, Shoulder Impingement Syndrome, Disorder of Rotator Cuff
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Specific exercise group
Control exercise group
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Pain focused on measuring Subacromial pain, Impingement, Exercises, Physical therapy, Primary care
Eligibility Criteria
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
Sites / Locations
- Primary Care unit "Rörelse & Hälsa"
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Specific exercise group
Control exercise group
Arm Description
A progressive program of strength-endurance exercises for the rotator cuff and scapula stabilizing muscles combined with mobilization of the joint capsule when needed
General movements for the neck and shoulder and self-stretching. No progression some addition of exercises during the three month period.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Disabilities of the arm, shoulder and hand
Self-assessment of the ability to performed exemplified activities. 0 indicates a non-affected upper extremity.
VAS for pain
Self-assessed for pain at rest, in activity and at night if it disturbs sleeping
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.
The Patient Specific functional Scale
Self-selected functional activities to relate efficacy to during follow-ups.
Euro Qol VAS (EQ VAS)
In EQ VAS the patients assess their health state on a vertical line valued from 0-100.
Full Information
NCT ID
NCT01885377
First Posted
June 18, 2013
Last Updated
August 9, 2022
Sponsor
Linkoeping University
Collaborators
University Hospital, Linkoeping, Ostergotland County Council, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT01885377
Brief Title
SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain
Acronym
SWESS
Official Title
SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain - a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 2011 (Actual)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
March 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University
Collaborators
University Hospital, Linkoeping, Ostergotland County Council, Sweden
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain, Shoulder Impingement Syndrome, Disorder of Rotator Cuff, Subacromial Bursitis
Keywords
Subacromial pain, Impingement, Exercises, Physical therapy, Primary care
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
164 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Specific exercise group
Arm Type
Experimental
Arm Description
A progressive program of strength-endurance exercises for the rotator cuff and scapula stabilizing muscles combined with mobilization of the joint capsule when needed
Arm Title
Control exercise group
Arm Type
Active Comparator
Arm Description
General movements for the neck and shoulder and self-stretching. No progression some addition of exercises during the three month period.
Intervention Type
Other
Intervention Name(s)
Specific exercise group
Other Intervention Name(s)
•Strength-endurance exercises, •Rotator cuff, •Scapular stabilization, •Eccentric, •Posture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control exercise group
Other Intervention Name(s)
•Movement exercises, •Stretching, •Posture
Intervention Description
A program with movements to maintain flexibility in the neck and shoulder muscles. Initially PT-tutored every week and then every other week.
Primary Outcome Measure Information:
Title
The Constant-Murley shoulder assessment
Description
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.
Time Frame
Baseline and change 3-, 6- and 12 months
Secondary Outcome Measure Information:
Title
Euro Qol 5D index (EQ 5D)
Description
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.
Time Frame
Baseline and change 3-, 6- and 12 months
Title
Disabilities of the arm, shoulder and hand
Description
Self-assessment of the ability to performed exemplified activities. 0 indicates a non-affected upper extremity.
Time Frame
Baseline and change 3-, 6- and 12 months
Title
VAS for pain
Description
Self-assessed for pain at rest, in activity and at night if it disturbs sleeping
Time Frame
Baseline and change 3-, 6- and 12 months
Title
Patients Global Impression of Change (PGIC)
Description
The patients are asked to assess change. A scale ranging from getting worse by the intervention to be recovered.
Time Frame
At follow-up: 3-, 6- and 12 months
Title
The Patient Specific functional Scale
Description
Self-selected functional activities to relate efficacy to during follow-ups.
Time Frame
Baseline and change 3-, 6- and 12 months
Title
Euro Qol VAS (EQ VAS)
Description
In EQ VAS the patients assess their health state on a vertical line valued from 0-100.
Time Frame
Baseline and change 3-, 6- and 12 months
Other Pre-specified Outcome Measures:
Title
Hospital Anxiety and Depression Scale (HAD)
Description
To screen mental health (depression and/or anxiety) in all included patients. Maximum score is 21 points for the depression and anxiety part respectively. The higher score, the higher risk of a depression and/or anxiety.
Time Frame
Baseline
Title
Sick-leave and return to work or working status
Description
Patient reported can be double checked by the Swedish Social Insurance Agency.
Time Frame
Baseline, 3-, 6- and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgitta Öberg, Professor
Organizational Affiliation
Div. of Physical Therapy, Dept. of Medical and Health Sciences, Linköping University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lars Adolfsson, Professor
Organizational Affiliation
Dept. of Orthopaedics, University Hospital Linköping & Linköping University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kajsa Johansson, PhD
Organizational Affiliation
Div. of Physical Therapy, Dept. of Medical and Health Sciences, Linköping University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Primary Care unit "Rörelse & Hälsa"
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
12. IPD Sharing Statement
Citations:
Citation
PMID: 22349588
Results Reference
background
Learn more about this trial
SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain
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