- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01885377
SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain (SWESS)
SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain - a Randomized Clinical Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Linköping, Sweden, 581 85
- Primary Care unit "Rörelse & Hälsa"
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Specific exercise group
A progressive program of strength-endurance exercises for the rotator cuff and scapula stabilizing muscles combined with mobilization of the joint capsule when needed
|
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.
Other Names:
|
Active Comparator: Control exercise group
General movements for the neck and shoulder and self-stretching.
No progression some addition of exercises during the three month period.
|
A program with movements to maintain flexibility in the neck and shoulder muscles.
Initially PT-tutored every week and then every other week.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Constant-Murley shoulder assessment
Time Frame: Baseline and change 3-, 6- and 12 months
|
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)
Time Frame: Baseline and change 3-, 6- and 12 months
|
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
Time Frame: Baseline and change 3-, 6- and 12 months
|
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
Time Frame: Baseline and change 3-, 6- and 12 months
|
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)
Time Frame: At follow-up: 3-, 6- and 12 months
|
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
Time Frame: Baseline and change 3-, 6- and 12 months
|
Self-selected functional activities to relate efficacy to during follow-ups.
|
Baseline and change 3-, 6- and 12 months
|
Euro Qol VAS (EQ VAS)
Time Frame: Baseline and change 3-, 6- and 12 months
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital Anxiety and Depression Scale (HAD)
Time Frame: Baseline
|
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.
|
Baseline
|
Sick-leave and return to work or working status
Time Frame: Baseline, 3-, 6- and 12 months
|
Patient reported can be double checked by the Swedish Social Insurance Agency.
|
Baseline, 3-, 6- and 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Birgitta Öberg, Professor, Div. of Physical Therapy, Dept. of Medical and Health Sciences, Linköping University
- Study Director: Lars Adolfsson, Professor, Dept. of Orthopaedics, University Hospital Linköping & Linköping University
- Principal Investigator: Kajsa Johansson, PhD, Div. of Physical Therapy, Dept. of Medical and Health Sciences, Linköping University
Publications and helpful links
General Publications
- PMID: 22349588
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8820 PV-JN-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Shoulder Impingement Syndrome
-
Mahidol UniversityCompletedSubacromial Impingement Syndrome | Shoulder Impingement Syndrome | Subacromial Pain Syndrome | Subacromial Impingement | Impingement Syndrome, ShoulderIndonesia
-
Copenhagen University Hospital, HvidovreUniversity of Copenhagen; Aalborg University; Metropolitan University CollegeCompletedSubacromial Impingement SyndromeDenmark
-
Uskudar State HospitalNot yet recruitingSubacromial Impingement Syndrome | Shoulder Impingement Syndrome | Shoulder Pain | Subacromial Impingement | Shoulder Impingement
-
King Saud UniversityUnknownImpingement Syndrome, ShoulderSaudi Arabia
-
Hadassah Medical OrganizationUnknownShoulder Impingement Syndrome.
-
National Taiwan University HospitalCompletedShoulder Impingement Syndrome (SIS); Round Shoulder Posture (RSP)Taiwan
-
Central Finland Hospital DistrictOulu University Hospital; Academy of FinlandActive, not recruitingSubacromial Impingement SyndromeFinland
-
Linkoeping UniversityCompletedSubacromial Impingement SyndromeSweden
-
Cairo UniversityCompletedImpingement Syndrome, ShoulderEgypt
-
Sacred Heart UniversityNova Southeastern UniversityCompletedSubacromial Impingement Syndrome | Subacromial Impingement
Clinical Trials on Specific exercise group
-
Riphah International UniversityCompletedSports Physical TherapyPakistan
-
Hacettepe UniversityCompleted
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI); United States Department of Defense; National...RecruitingLung Cancer | Cancer of ThoraxUnited States
-
The University of Hong KongUnknown
-
Universidad de ColimaCompleted
-
National Taiwan University HospitalCompletedCervical Radiculopathy | Cervical MyelopathyTaiwan
-
Linkoeping UniversityCompleted
-
Seoul National University HospitalUnknownHip Fractures
-
National Taiwan University HospitalNational Health Research Institutes, TaiwanCompletedRecurrent Low Back PainTaiwan
-
Cooperativa de Ensino Superior, Politécnico e UniversitárioCompletedBalance; Distorted