Chronic PainNCT02701465
Blood Flow - an Underlying Mechanism Behind Clinical Improvements in Patients With Subacromial Pain Syndrome?
A study testing Exercise: local high intensity interval exercise and Exercise: best clinical practice in people with Chronic Pain, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The purpose of this randomized clinical trial is two-fold. Firstly to see if patients suffering Subacromial Pain Syndrome can improve blood flow in the supraspinatus muscle in their shoulder, and secondly to investigate how changes in this blood flow are related to pain experience and shoulder function. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Exercise: local high intensity interval exercise and Exercise: best clinical practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNorway
- Study dates
- 2 Jan 2016to Apr 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- shoulder pain for longer than three months
- clinical findings indicative of subacromial pain syndrome (evaluated by Hawkins-Kennedy sign, Neers sign, painful arch and Yokum test)
- normal passive range of motion of the shoulder
Who cannot join
- subjects unable to provide an informed consent
- lack of ability to complete the intervention
- full rupture of the tendon of m. supraspinatus
- planned shoulder surgery, or previous shoulder surgery on affected shoulder
- other musculoskeletal problem that could explain the symptoms
- adhesive capsulitis
Show all 15Show fewer
- pregnancy
- rheumatoid arthritis
- symptomatic osteoarthritis of the shoulder/shoulder girdle
- glenohumeral instability
- widespread pain syndrome
- unstable underlying heart disease
- cortisone injections in the shoulder the last month
- allergies
- other serious mental or somatic disease (i.e. psychosis or active cancer disease).
Trial locations and contacts
1 site in 1 country.
Norway1 site
St. Olavs Hospital, back-neck-shoulder multidiciplinary clinic
Trondheim
About this study
The purpose of this randomized clinical trial is two-fold. Firstly to see if patients suffering Subacromial Pain Syndrome can improve blood flow in the supraspinatus muscle in their shoulder, and secondly to investigate how changes in this blood flow are related to pain experience and shoulder function.
- Conditions
- Chronic Pain
- Being tested
- Exercise: local high intensity interval exercise, Exercise: best clinical practice
- Keywords
- Shoulder, Exercise therapy
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise: local high intensity interval exerciseOther
The subjects in this arm will receive four high intensity (80% of peak work rate) four-minute interval exercises for the abduction movement in the plane of the scapula (m. supraspinatus), supervised three times per week. In addition they will perform the exercise program described for the control group.
Exercise: best clinical practiceOther
The control group will receive a best clinical practice home-exercise program, with regular follow-ups at the shoulder clinic every other week. The details are described in Granviken et al. (2015).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The subjects in this arm will receive four high intensity (80% of peak work rate) four-minute interval exercises for the abduction movement in the plane of the scapula (m. supraspinatus), supervised three times per week. In addition they will perform the exercise program described for the control group. Receives: Other: Exercise: local high intensity interval exercise |
| Control group | Active comparator | The control group will receive a best clinical practice home-exercise program, with regular follow-ups at the shoulder clinic every other week. The details are described in Granviken et al. (2015). Receives: Other: Exercise: best clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to exhaustion, incremental test
participants abduct their shoulder up to 90 degrees in scapula's plane (scapularization) at a frequency of 0,5 Hz. Every minute the load is increased with 250 grams. The test is stopped if participant fails to maintain pace or movement quality, or experiences increased pain. Time at failure is noted as the result.
Measured: Week 0
Secondary outcomes (14)
SPADI questionnaire
Subjective pain and function outcomes (Likert scales)
Measured: Week 0
SPADI questionnaire
Subjective pain and function outcomes (Likert scales)
Measured: Pre+post-test (8 weeks in-between)
Weight
Weight (kg)
Measured: Week 0
Height
Height (cm)
Measured: Week 0
Age
Age (years)
Measured: Week 0
Duration of symptoms
Duration of symptoms (months)
Measured: Week 0
Affected shoulder
What shoulder is affected (left/right)
Measured: Week 0
Socioeconomic status
The patient fills in a questionnaire stating number of children, marital status, welfare status and working situation
Measured: Week 0
1 repetition maximum (1RM), bilateral shoulder test
After warmup: maximal strength was measured as the weight the subject could manage to lift once - usually achieved in 3-5 attempts. The movement conducted was the earlier described scapularization movement.
Measured: Week 0
1 repetition maximum (1RM), bilateral shoulder test
After warmup: maximal strength was measured as the weight the subject could manage to lift once - usually achieved in 3-5 attempts. The movement conducted was the earlier described scapularization movement.
Measured: Week 8
Time to exhaustion, steady state
Subject abduct their shoulder up to 90 degrees in scapula's plane (scapularization) at a frequency of 0,5 Hz. The load is set to 80% of the incremental time to exhaustion test. The test is stopped if the fails to maintain pace or movement quality, or the subject experience increased pain. Time at failure is noted as the result.
Measured: Week 0
Time to exhaustion, steady state
Subject abduct their shoulder up to 90 degrees in scapula's plane (scapularization) at a frequency of 0,5 Hz. The load is set to 80% of the incremental time to exhaustion test. The test is stopped if the fails to maintain pace or movement quality, or the subject experience increased pain. Time at failure is noted as the result.
Measured: Week 8
Regional blood flow in m. supraspinatus, using contrast enhanced ultrasound (concentration of white analyzed as decibels in region of interest)
Baseline images will be taken with ultrasonic device to confirm an intact m. supraspinatus. An intravenous line will be inserted in the contralateral arm and the patient will be injected with a bolus of contrast dye (Optison, 3 ml bolus, 0.19 mg / mL perflutren). The injection is administered by a physician related to the research project. Measurements of regional blood flow at rest made are of the supraspinatus tendon. Then the participants perform a standardized training exercise to recruit the vasculature in m. supraspinatus (scapularization to 90 degrees, 80% of TTU weight (incremental), 3 minutes). Post-exercise images are taken immediately after this.
Measured: Week 0
Regional blood flow in m. supraspinatus, using contrast enhanced ultrasound (concentration of white analyzed as decibels in region of interest)
Baseline images will be taken with ultrasonic device to confirm an intact m. supraspinatus. An intravenous line will be inserted in the contralateral arm and the patient will be injected with a bolus of contrast dye (Optison, 3 ml bolus, 0.19 mg / mL perflutren). The injection is administered by a physician related to the research project. Measurements of regional blood flow at rest made are of the supraspinatus tendon. Then the participants perform a standardized training exercise to recruit the vasculature in m. supraspinatus (scapularization to 90 degrees, 80% of TTU weight (incremental), 3 minutes). Post-exercise images are taken immediately after this.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study start2 Jan 2016
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Jan Hoff, PhD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701465
- Sponsor's protocol ID
- 666
- Status last verified
- Mar 2019
- First submitted
- 25 Feb 2016
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow - an Underlying Mechanism Behind Clinical Improvements in Patients With Subacromial Pain Syndrome?
- ClinicalTrials.gov ID
- NCT02701465
- Acronym / sponsor ID
- 666
- Conditions
- Chronic Pain
- Keywords
- Shoulder, Exercise therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- 2 Jan 2016 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 8 Mar 2016 (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 randomized clinical trial is two-fold. Firstly to see if patients suffering Subacromial Pain Syndrome can improve blood flow in the supraspinatus muscle in their shoulder, and secondly to investigate how changes in this blood flow are related to pain experience and shoulder function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Exercise: local high intensity interval exerciseThe subjects in this arm will receive four high intensity (80% of peak work rate) four-minute interval exercises for the abduction movement in the plane of the scapula (m. supraspinatus), supervised three times per week. In addition they will perform the exercise program described for the control group. |
| Control group | Active comparator | Other: Exercise: best clinical practiceThe control group will receive a best clinical practice home-exercise program, with regular follow-ups at the shoulder clinic every other week. The details are described in Granviken et al. (2015). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- shoulder pain for longer than three months
- clinical findings indicative of subacromial pain syndrome (evaluated by Hawkins-Kennedy sign, Neers sign, painful arch and Yokum test)
- normal passive range of motion of the shoulder
Key exclusion criteria (15 listed)
- subjects unable to provide an informed consent
- lack of ability to complete the intervention
- full rupture of the tendon of m. supraspinatus
- planned shoulder surgery, or previous shoulder surgery on affected shoulder
- other musculoskeletal problem that could explain the symptoms
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 |
|---|---|---|
| Exercise: local high intensity interval exerciseThe subjects in this arm will receive four high intensity (80% of peak work rate) four-minute interval exercises for the abduction movement in the plane of the scapula (m. supraspinatus), supervised three times per week. In addition they will perform the exercise program described for the control group. | Other | Intervention group |
| Exercise: best clinical practiceThe control group will receive a best clinical practice home-exercise program, with regular follow-ups at the shoulder clinic every other week. The details are described in Granviken et al. (2015). | Other | Control group |
Primary outcome
Time to exhaustion, incremental test
Time frame: Week 0
participants abduct their shoulder up to 90 degrees in scapula's plane (scapularization) at a frequency of 0,5 Hz. Every minute the load is increased with 250 grams. The test is stopped if participant fails to maintain pace or movement quality, or experiences increased pain. Time at failure is noted as the result.
14 secondary outcomes
SPADI questionnaire
Time frame: Week 0
SPADI questionnaire
Time frame: Pre+post-test (8 weeks in-between)
Weight
Time frame: Week 0
Height
Time frame: Week 0
Age
Time frame: Week 0
Duration of symptoms
Time frame: Week 0
Affected shoulder
Time frame: Week 0
Socioeconomic status
Time frame: Week 0
1 repetition maximum (1RM), bilateral shoulder test
Time frame: Week 0
1 repetition maximum (1RM), bilateral shoulder test
Time frame: Week 8
Time to exhaustion, steady state
Time frame: Week 0
Time to exhaustion, steady state
Time frame: Week 8
Regional blood flow in m. supraspinatus, using contrast enhanced ultrasound (concentration of white analyzed as decibels in region of interest)
Time frame: Week 0
Regional blood flow in m. supraspinatus, using contrast enhanced ultrasound (concentration of white analyzed as decibels in region of interest)
Time frame: Week 8
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 22 Mar 2019.
- Individual participant dataSharing planned: No
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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.
Jan Hoff, PhD 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 Exercise: local high intensity interval exercise and Exercise: best clinical practice in people with Chronic Pain, 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 3 inclusion and 15 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 22 Mar 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?
Time to exhaustion, incremental test (time frame: Week 0). 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 22 Mar 2019.