Shoulder Impingement SyndromeNCT01257113
Supervised Exercise Therapy vs Home Exercises for Patients With Subacromial Impingement
A study testing supervised exercise and homebased exercises in people with Shoulder Impingement Syndrome, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The purpose of this study is to determine whether there are any difference between supervised exercise therapy and homebased exercise when looking at pain and function for patients with shoulder pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder Impingement Syndrome
- What is being tested?
- supervised exercise and homebased exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2011to Apr 2013
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain in one shoulder
- Had the condition for more than 12 weeks
- Pain at abduction (must be present in some part between 60 and 120 degrees)
- Pain/ weakness in isometric external rotation
- Positive Hawkins test
Who cannot join
- Instability
- Labral pathology
- Acromioclavicular joint (AC-joint) pathology
- Complete rupture in the rotatorcuff
- Glenohumeral osteoarthritis
- Previously operated on current shoulder
Show all 10Show fewer
- The pain comes from neck pathology
- Rheumatoid arthritis or other serious physical or mental illness
- Lack of Norwegian language
- Unable to start
Trial locations and contacts
1 site in 1 country.
Norway1 site
Tverrfaglig Poliklinikk, rygg-nakke-skulder. Fys.Med. og rehab., St.Olavs Hospital
Trondheim, 7006
About this study
Official title: Is Supervised Exercise Therapy a Better Option Than Home Exercises for Patients With Subacromial Impingement When Looking at Pain and Function?
The purpose of this study is to determine whether there are any difference between supervised exercise therapy and homebased exercise when looking at pain and function for patients with shoulder pain.
Read the detailed description
Shoulder pain is common in the population. Various treatment modalities are used. According to the literature, it is equally good results for home exercises and for guided exercise therapy. The purpose of this study is to look at this again and determine whether there are any difference between supervised exercise therapy and homebased exercise when looking at pain and function for patients with subacromial impingement.
- Conditions
- Shoulder Impingement Syndrome
- Being tested
- supervised exercise, homebased exercises
- Keywords
- shoulder pain, shoulder impingement, rotatorcuff pathology, supervised exercise, homebased exercise
- Medical subject headings
- Shoulder Impingement Syndrome, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supervised exerciseOther
This group will receive 10 classes of supervised exercise in the 6 weeks intervention. In this classes the patients will be with a physiotherapist that will adjust their home-exercise program and make sure they do the exercises in a good way. They will receive 4-6 exercises they shall do 3 times with 30 repetitions, 2 times every day. If necessary, they should also do stretching exercises
homebased exercisesOther
This group will receive 1 class of supervised exercise at the beginning of the 6 weeks intervention. In this class the patients will be with a physiotherapist that will put together a home-exercise program and make sure they do the exercises in a good way. They will receive 4-6 exercises they shall do 3 times with 30 repetitions, 2 times every day. If necessary, they should also do stretching exercises
| Study group | Role | What they receive |
|---|---|---|
| supervised exercise | Experimental | The group gets 10 supervised exerciseclasses at the physiotherapy clinic in addition to homebased exercises Receives: Other: supervised exercise |
| homebased exercises | Experimental | The group gets 1 supervised exerciseclass before they do all their exercises at home Receives: Other: homebased exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain and function 1
Shoulder Pain and Disability Index
Measured: Baseline
Pain and function 2
Shoulder Pain and Disability Index
Measured: At 6 weeks
Pain and function 3
Shoulder Pain and Disability Index
Measured: At 6 months
Secondary outcomes (13)
Fear avoidance 1
Fear-Avoidance Beliefs Questionnaire. Modified version with questions about shoulder instead of back
Measured: Baseline
Fear avoidance 2
Fear-Avoidance Beliefs Questionnaire. Modified version with questions about shoulder instead of back.
Measured: At 6 weeks
Quality of life 1
The Short-Form 36 questionnaire
Measured: Baseline
Quality of life 2
The Short-Form 36 questionnaire
Measured: At 6 weeks
Pain the last week
Numeric pain rating scale
Measured: Baseline and once a week for 6 weeks
Active range of motion 1
Abduction, flexion, external rotation and internal rotation measured with inclinometer
Measured: Baseline
Active range of motion 2
Abduction, flexion, external rotation and internal rotation measured with inclinometer
Measured: At 6 weeks
Impingement tests 1
Hawkins test, painful arc test and isometric external rotation test is beeing conducted and scored positive or negative
Measured: Baseline
Impingement tests 2
Hawkins test, painful arc test and isometric external rotation test is beeing conducted and scored positive or negative
Measured: At 6 weeks
Work status 1
Registration of the patients work status
Measured: Baseline
Work status 2
Registration of the patients work status
Measured: At 6 weeks
Work status 3
Registration of the patients work status
Measured: At 6 months
Patient satisfaction
2 questions, one question about benefit and one about satisfaction
Measured: At 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionDec 2012
- Study completionApr 2013
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 Impingement SyndromeStudies of the same condition, open and under way.
- 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ottar Vasseljen, Dr.Philos, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257113
- Sponsor's protocol ID
- 2010/2591
- Status last verified
- Nov 2019
- First submitted
- 8 Dec 2010
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Granviken F, Vasseljen O. Home exercises and supervised exercises are similarly effective for people with subacromial impingement: a randomised trial. J Physiother. 2015 Jul;61(3):135-41. doi: 10.1016/j.jphys.2015.05.014. Epub 2015 Jun 18.
PubMed 26093810
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Supervised Exercise Therapy a Better Option Than Home Exercises for Patients With Subacromial Impingement When Looking at Pain and Function?
- ClinicalTrials.gov ID
- NCT01257113
- Acronym / sponsor ID
- 2010/2591
- Conditions
- Shoulder Impingement Syndrome
- Keywords
- shoulder pain, shoulder impingement, rotatorcuff pathology, supervised exercise, homebased exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 9 Dec 2010 (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.
The purpose of this study is to determine whether there are any difference between supervised exercise therapy and homebased exercise when looking at pain and function for patients with shoulder pain.
Detailed description
Shoulder pain is common in the population. Various treatment modalities are used. According to the literature, it is equally good results for home exercises and for guided exercise therapy. The purpose of this study is to look at this again and determine whether there are any difference between supervised exercise therapy and homebased exercise when looking at pain and function for patients with subacromial impingement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| supervised exercise | Experimental | Other: supervised exerciseThe group gets 10 supervised exerciseclasses at the physiotherapy clinic in addition to homebased exercises |
| homebased exercises | Experimental | Other: homebased exercisesThe group gets 1 supervised exerciseclass before they do all their exercises at home |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pain in one shoulder
- Had the condition for more than 12 weeks
- Pain at abduction (must be present in some part between 60 and 120 degrees)
- Pain/ weakness in isometric external rotation
- Positive Hawkins test
Key exclusion criteria (10 listed)
- Instability
- Labral pathology
- Acromioclavicular joint (AC-joint) pathology
- Complete rupture in the rotatorcuff
- Glenohumeral osteoarthritis
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 |
|---|---|---|
| supervised exerciseThis group will receive 10 classes of supervised exercise in the 6 weeks intervention. In this classes the patients will be with a physiotherapist that will adjust their home-exercise program and make sure they do the exercises in a good way. They will receive 4-6 exercises they shall do 3 times with 30 repetitions, 2 times every day. If necessary, they should also do stretching exercises | Other | supervised exercise |
| homebased exercisesThis group will receive 1 class of supervised exercise at the beginning of the 6 weeks intervention. In this class the patients will be with a physiotherapist that will put together a home-exercise program and make sure they do the exercises in a good way. They will receive 4-6 exercises they shall do 3 times with 30 repetitions, 2 times every day. If necessary, they should also do stretching exercises | Other | homebased exercises |
Primary outcome
Pain and function 1
Time frame: Baseline
Shoulder Pain and Disability Index
Pain and function 2
Time frame: At 6 weeks
Shoulder Pain and Disability Index
Pain and function 3
Time frame: At 6 months
Shoulder Pain and Disability Index
13 secondary outcomes
Fear avoidance 1
Time frame: Baseline
Fear avoidance 2
Time frame: At 6 weeks
Quality of life 1
Time frame: Baseline
Quality of life 2
Time frame: At 6 weeks
Pain the last week
Time frame: Baseline and once a week for 6 weeks
Active range of motion 1
Time frame: Baseline
Active range of motion 2
Time frame: At 6 weeks
Impingement tests 1
Time frame: Baseline
Impingement tests 2
Time frame: At 6 weeks
Work status 1
Time frame: Baseline
Work status 2
Time frame: At 6 weeks
Work status 3
Time frame: At 6 months
Patient satisfaction
Time frame: At 6 weeks
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 21 Nov 2019.
- Results publication: PubMed 26093810Granviken F, Vasseljen O. Home exercises and supervised exercises are similarly effective for people with subacromial impingement: a randomised trial. J Physiother. 2015 Jul;61(3):135-41. doi: 10.1016/j.jphys.2015.05.014. Epub 2015 Jun 18.
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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.
Ottar Vasseljen, Dr.Philos principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supervised exercise and homebased exercises in people with Shoulder Impingement Syndrome, run by Norwegian University of Science and Technology at 1 site in Norway.
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 5 inclusion and 10 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 21 Nov 2019. 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 Norway. 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?
Pain and function 1 (time frame: Baseline). The study lists 3 primary outcomes in all. 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 NCT01257113, 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 21 Nov 2019.