Shoulder PainSWESSNCT01885377
SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain
A study testing Specific exercise group in people with Shoulder Pain and Shoulder Impingement Syndrome, run by Linkoeping University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 67 years
- Conditions the study is for
- Shoulder Pain, Shoulder Impingement Syndrome, Disorder of Rotator Cuff
- What is being tested?
- Specific exercise group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2011to Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
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.
Read the 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.
- Conditions
- Shoulder Pain, Shoulder Impingement Syndrome, Disorder of Rotator Cuff, Subacromial Bursitis
- Being tested
- Specific exercise group, Control exercise group
- Keywords
- Subacromial pain, Impingement, Exercises, Physical therapy, Primary care
- Medical subject headings
- Shoulder Pain, Shoulder Impingement Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific exercise groupOther
Also called •Strength-endurance exercises, •Rotator cuff, •Scapular stabilization, •Eccentric
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.
Control exercise groupOther
Also called •Movement exercises, •Stretching, •Posture
A program with movements to maintain flexibility in the neck and shoulder muscles. Initially PT-tutored every week and then every other week.
| Study group | Role | What they receive |
|---|---|---|
| Specific exercise group | Experimental | A progressive program of strength-endurance exercises for the rotator cuff and scapula stabilizing muscles combined with mobilization of the joint capsule when needed Receives: Other: Specific exercise group |
| Control exercise group | Active comparator | General movements for the neck and shoulder and self-stretching. No progression some addition of exercises during the three month period. Receives: Other: Control exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and change 3-, 6- and 12 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: At follow-up: 3-, 6- and 12 months
The Patient Specific functional Scale
Self-selected functional activities to relate efficacy to during follow-ups.
Measured: 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.
Measured: Baseline and change 3-, 6- and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startSep 2011
- Primary completionMar 2020
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- University Hospital, Linkoeping, Ostergotland County Council, Sweden
- Responsible party
- Principal investigator, Kajsa Johansson, Linkoeping University
- Investigators
- Birgitta Öberg, Professor, Study chair, Div. of Physical Therapy, Dept. of Medical and Health Sciences, Linköping UniversityLars Adolfsson, Professor, Study director, Dept. of Orthopaedics, University Hospital Linköping & Linköping UniversityKajsa Johansson, PhD, Principal investigator, Div. of Physical Therapy, Dept. of Medical and Health Sciences, Linköping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885377
- Sponsor's protocol ID
- 8820 PV-JN-1
- Acronym
- SWESS
- Status last verified
- Aug 2022
- First submitted
- 18 Jun 2013
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
PMID: 22349588
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01885377
- Acronym / sponsor ID
- SWESS / 8820 PV-JN-1
- Conditions
- Shoulder Pain, Shoulder Impingement Syndrome, Disorder of Rotator Cuff, Subacromial Bursitis
- Keywords
- Subacromial pain, Impingement, Exercises, Physical therapy, Primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- University Hospital, Linkoeping, Ostergotland County Council, Sweden
- Study start
- Sep 2011 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 25 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specific exercise group | Experimental | Other: Specific exercise groupA progressive program of strength-endurance exercises for the rotator cuff and scapula stabilizing muscles combined with mobilization of the joint capsule when needed |
| Control exercise group | Active comparator | Other: Control exercise groupGeneral movements for the neck and shoulder and self-stretching. No progression some addition of exercises during the three month period. |
Who may qualify
- Ages
- 30 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 2 weeks of symptom duration
- Typical history and pain location (C5 dermatome)
- Neer impingement sign
- Hawkins-Kennedy impingement sign
- Jobe supraspinatus test
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specific exercise groupAlso: •Strength-endurance exercises, •Rotator cuff, •Scapular stabilization, •EccentricA 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 | Specific exercise group |
| Control exercise groupAlso: •Movement exercises, •Stretching, •PostureA program with movements to maintain flexibility in the neck and shoulder muscles. Initially PT-tutored every week and then every other week. | Other | Control exercise group |
Primary outcome
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.
6 secondary outcomes
Euro Qol 5D index (EQ 5D)
Time frame: 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
VAS for pain
Time frame: 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 Patient Specific functional Scale
Time frame: Baseline and change 3-, 6- and 12 months
Euro Qol VAS (EQ VAS)
Time frame: Baseline and change 3-, 6- and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- BackgroundPMID: 22349588
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Birgitta Öberg, Professor study chair
Div. of Physical Therapy, Dept. of Medical and Health Sciences, Linköping University
Lars Adolfsson, Professor study director
Dept. of Orthopaedics, University Hospital Linköping & Linköping University
Kajsa Johansson, PhD principal investigator
Div. of Physical Therapy, Dept. of Medical and Health Sciences, Linköping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific exercise group in people with Shoulder Pain and Shoulder Impingement Syndrome, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Constant-Murley shoulder assessment (time frame: Baseline and change 3-, 6- and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01885377, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.