Subacromial Pain SyndromeNCT03317808
Exercise for Subacromial Pain Syndrome
A study testing Different exercise in people with Subacromial Pain Syndrome, run by Oslo University Hospital at 1 site in Norway.
Trial summary
This study evaluates the effect of Heavy Slow Resistance exercise (HSR) exercise in comparison with traditional supervised exercise as treatment for patients with subacromial shoulder pain. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Subacromial Pain Syndrome
- What is being tested?
- Different exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteNorway
- Study dates
- 16 Oct 2017to 13 Dec 2018
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Shoulder pain > Three months
- Subacromial pain
- Dysfunction or pain during abduction
- Pain during isometric strength test of abduction or external rotation of the shoulder.
- Positive Hawkins test
- Normal passive range of movement in the glenohumeral joint
Who cannot join
- Surgery of the affected shoulder
- Patients that are not considered suitable to complete the treatment, or able to answer a Norwegian questionnaire
- Shoulder dislocation or shoulder instability
- Clinical sign of cervical nerve root affection
- Rheumatoid arthritis
- Clinical sign of full rupture of the rotator cuff.
- Pregnancy
- Cortisone injection past six weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heavy Slow Resistance Exercise for Subacromial Pain Syndrome
This study evaluates the effect of Heavy Slow Resistance exercise (HSR) exercise in comparison with traditional supervised exercise as treatment for patients with subacromial shoulder pain. The purpose is to evaluate if HSR is feasible fir these patients, and compare its effect to traditional exercise at pain and function of the shoulder. One half will complete the heavy slow resistance exercise, the other will complete the conventional exercise.
- Conditions
- Subacromial Pain Syndrome
- Being tested
- Different exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different exerciseDiagnostic test
Evaluating the difference between Heavy slow resistance and traditional exercise, based on the SPADI score.
| Study group | Role | What they receive |
|---|---|---|
| Heavy slow resistance exercise | Active comparator | Not described Receives: Diagnostic Test: Different exercise |
| Traditional supervised exercise | Placebo comparator | Not described Receives: Diagnostic Test: Different exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline SPADI score at 12- and 24 weeks.
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. Both dimensions account for 50% of the overall score, and scores from 0 to 100.
Measured: Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up.
Secondary outcomes (6)
Change from Baseline "Pain in rest last week" score at 12- and 24 weeks.
11 point Likert-type scale, 0 =no pain, 10 = worst possible pain. Measured by marking a clean visual analogue scale, and later transferred to a score.
Measured: Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up.
Change from Baseline "Pain in activity last week" score at 12- and 24 weeks.
11 point Likert-type scale, 0 =no pain, 10 = worst possible pain. Measured by marking a clean visual analogue scale, and later transferred to a score.
Measured: Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up.
Change From Baseline "The ability to carry a 5kg carry bag" score at 12- and 24 weeks.
11 point Likert-type scale, 0 = no problem, 10 = impossible. Measured by marking a clean visual analogue scale, and later transferred to a score.
Measured: Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up.
Change from Baseline DASH score at 12- and 24 weeks.
DISABILITIES OF THE ARM, SHOULDER AND HAND (DASH) is a 30 points questionnaire about the disability of the shoulder. Answers from 0 to 5; 0 0 No problem completing the activity, 5 = Impossible to complete the activity. Total score is calculated by a summary of the scores, subtracted by 30 and divided by 1.2.
Measured: Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up.
Change from Baseline Active range of motion of the shoulder at 12- and 24 weeks.
A total score the flection, abduction and external rotation of the shoulder. Measured by goniometer.
Measured: Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up.
Change from "The ability to take something down from a high shelf" score at 12- and 24 weeks.
11 point Likert-type scale, 0 = no problem, 10 = impossible. Measured by marking a clean visual analogue scale, and later transferred to a score.
Measured: Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start16 Oct 2017
- Primary completion13 Dec 2018
- Study completion13 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hans-Hugo Fredriksen Høiland, Oslo University Hospital
- Investigators
- Høiland, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317808
- Sponsor's protocol ID
- 2017/1277
- Status last verified
- Jan 2019
- First submitted
- 15 Oct 2017
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heavy Slow Resistance Exercise for Subacromial Pain Syndrome
- ClinicalTrials.gov ID
- NCT03317808
- Acronym / sponsor ID
- 2017/1277
- Conditions
- Subacromial Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 13 Dec 2018 (actual)
- Study completion
- 13 Dec 2018 (actual)
- First posted
- 23 Oct 2017 (actual)
- 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.
This study evaluates the effect of Heavy Slow Resistance exercise (HSR) exercise in comparison with traditional supervised exercise as treatment for patients with subacromial shoulder pain. The purpose is to evaluate if HSR is feasible fir these patients, and compare its effect to traditional exercise at pain and function of the shoulder. One half will complete the heavy slow resistance exercise, the other will complete the conventional exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heavy slow resistance exercise | Active comparator | Diagnostic Test: Different exercise |
| Traditional supervised exercise | Placebo comparator | Diagnostic Test: Different exercise |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Shoulder pain > Three months
- Subacromial pain
- Dysfunction or pain during abduction
- Pain during isometric strength test of abduction or external rotation of the shoulder.
- Positive Hawkins test
Key exclusion criteria (8 listed)
- Surgery of the affected shoulder
- Patients that are not considered suitable to complete the treatment, or able to answer a Norwegian questionnaire
- Shoulder dislocation or shoulder instability
- Clinical sign of cervical nerve root affection
- Rheumatoid arthritis
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 |
|---|---|---|
| Different exerciseEvaluating the difference between Heavy slow resistance and traditional exercise, based on the SPADI score. | Diagnostic test | Heavy slow resistance exercise, Traditional supervised exercise |
Primary outcome
Change from Baseline SPADI score at 12- and 24 weeks.
Time frame: Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up.
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. Both dimensions account for 50% of the overall score, and scores from 0 to 100.
6 secondary outcomes
Change from Baseline "Pain in rest last week" score at 12- and 24 weeks.
Time frame: Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up.
Change from Baseline "Pain in activity last week" score at 12- and 24 weeks.
Time frame: Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up.
Change From Baseline "The ability to carry a 5kg carry bag" score at 12- and 24 weeks.
Time frame: Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up.
Change from Baseline DASH score at 12- and 24 weeks.
Time frame: Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up.
Change from Baseline Active range of motion of the shoulder at 12- and 24 weeks.
Time frame: Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up.
Change from "The ability to take something down from a high shelf" score at 12- and 24 weeks.
Time frame: Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up.
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 25 Jan 2019.
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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.
Høiland principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Different exercise in people with Subacromial Pain Syndrome, run by Oslo University Hospital 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 6 inclusion and 8 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 25 Jan 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. Some participants in this study may receive a placebo. 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?
Change from Baseline SPADI score at 12- and 24 weeks. (time frame: Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2019.