Rotator Cuff TendinopathyNCT01423682
The Influence of Eccentric Training on the Volume and Vascularisation of the Rotator Cuff in Patients With Rotator Cuff Tendinopathy and Healthy Subjects
A study testing Eccentric exercise in people with Rotator Cuff Tendinopathy, run by University Ghent at 1 site in Belgium.
Trial summary
Patients with rotator cuff tendinopathy make up a large part of the population in physiotherapy practice. The rotator cuff, a shoulder muscle group, plays an important role in causing pain. Tendons suffer large compression and friction, which can lead to degeneration of these tendons. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tendinopathy
- What is being tested?
- Eccentric exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2012to Jun 2015
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male/ Female
- 18-40 years old
- Unilateral shoulder pain for at least 3 months
- Pain of at least 3/10 on a visual analogue scale
- Painful arc or pain at end range abduction
- 2/3 impingement tests positive
Show all 10Show fewer
- 2/4 resistance tests positive
- Pain at insertion rotator cuff
- Male/ Female
- 18-40 years old
Who cannot join
- Spurling test positive
- Shoulder surgery in the past
- Osteoarthritis shoulder
- Full thickness ruptures
- Shoulder pain during the last 3 months
- Shoulder surgery in the past
- Neck pain or disability
- Systemic disease (e.g. Marfan, Ehlers Danlos,…)
Trial locations and contacts
1 site in 1 country.
About this study
Patients with rotator cuff tendinopathy make up a large part of the population in physiotherapy practice. The rotator cuff, a shoulder muscle group, plays an important role in causing pain. Tendons suffer large compression and friction, which can lead to degeneration of these tendons. Rehabilitation often leads to unsatisfying results.
In Achilles and patella tendinopathy, a new training program called eccentric training has shown very good results. Eccentric training contains exercises during which a force has to be resisted while the muscle lengthens instead of shortens. This would have a larger influence on tendon tissue. Some small studies also show promising results of eccentric training in patients with rotator cuff tendinopathy but the mechanisms behind these results remain unclear.
To investigate this, 30 patients with rotator cuff tendinopathy and 30 healthy subjects will be evaluated before and immediately after performing the exercise. Three measurements will be done: ultrasonographic measurement of tendon thickness, power Doppler imaging and measurement of microcirculation around the tendon with Oxygen to see. All measurements are non-invasive, pain free and without risks for the human body.
- Conditions
- Rotator Cuff Tendinopathy
- Being tested
- Eccentric exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric exerciseBehavioural
Patients and healthy subjects will perform an eccentric exercise during which a weight is lifted along the body and lowered with an extended arm at a slow speed. Weight is determined, based on pain in patients and based on force in healthy subjects.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Placebo comparator | Not described Receives: Behavioral: Eccentric exercise |
| Rotator cuff tendinopathy | Active comparator | Not described Receives: Behavioral: Eccentric exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tendon thickness measurement
Grey scale ultrasound examination is used.
Measured: After 30 minutes rest, before performing the exercise.
Tendon vascularisation examination.
Power Doppler ultrasound examination is used.
Measured: After 30 minutes rest, before performing the exercise.
Microcirculation around the tendon examination.
Oxygen to see (spectrophotometry and laser Doppler) will be used.
Measured: After 30 minutes rest, before performing the exercise.
Secondary outcomes (3)
Tendon thickness measurements.
Grey scale ultrasound examination is used.
Measured: 10 minutes after performing the exercise.
Tendon vascularisation examination.
Power Doppler ultrasound examination is used.
Measured: 10 minutes after performing the exercise.
Microcirculation around the tendon examination.
Oxygen to see (spectrophotometry and laser Doppler) will be used.
Measured: 10 minutes after performing the exercise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startApr 2012
- Primary completionApr 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TendinopathyStudies of the same condition, open and under way.
- More trials run by University GhentThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Responsible party
- Sponsor
- Investigators
- Ann Cools, MD, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423682
- Sponsor's protocol ID
- 2011/482
- Status last verified
- Nov 2021
- First submitted
- 23 Aug 2011
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Eccentric Training on the Volume and Vascularisation of the Rotator Cuff in Patients With Rotator Cuff Tendinopathy and Healthy Subjects
- ClinicalTrials.gov ID
- NCT01423682
- Acronym / sponsor ID
- 2011/482
- Conditions
- Rotator Cuff Tendinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Study start
- Apr 2012 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 26 Aug 2011 (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.
Patients with rotator cuff tendinopathy make up a large part of the population in physiotherapy practice. The rotator cuff, a shoulder muscle group, plays an important role in causing pain. Tendons suffer large compression and friction, which can lead to degeneration of these tendons. Rehabilitation often leads to unsatisfying results.
In Achilles and patella tendinopathy, a new training program called eccentric training has shown very good results. Eccentric training contains exercises during which a force has to be resisted while the muscle lengthens instead of shortens. This would have a larger influence on tendon tissue. Some small studies also show promising results of eccentric training in patients with rotator cuff tendinopathy but the mechanisms behind these results remain unclear.
To investigate this, 30 patients with rotator cuff tendinopathy and 30 healthy subjects will be evaluated before and immediately after performing the exercise. Three measurements will be done: ultrasonographic measurement of tendon thickness, power Doppler imaging and measurement of microcirculation around the tendon with Oxygen to see. All measurements are non-invasive, pain free and without risks for the human body.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Placebo comparator | Behavioral: Eccentric exercise |
| Rotator cuff tendinopathy | Active comparator | Behavioral: Eccentric exercise |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male/ Female
- 18-40 years old
- Unilateral shoulder pain for at least 3 months
- Pain of at least 3/10 on a visual analogue scale
- Painful arc or pain at end range abduction
Key exclusion criteria (8 listed)
- Spurling test positive
- Shoulder surgery in the past
- Osteoarthritis shoulder
- Full thickness ruptures
- Shoulder pain during the last 3 months
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 |
|---|---|---|
| Eccentric exercisePatients and healthy subjects will perform an eccentric exercise during which a weight is lifted along the body and lowered with an extended arm at a slow speed. Weight is determined, based on pain in patients and based on force in healthy subjects. | Behavioural | Healthy subjects, Rotator cuff tendinopathy |
Primary outcome
Tendon thickness measurement
Time frame: After 30 minutes rest, before performing the exercise.
Grey scale ultrasound examination is used.
Tendon vascularisation examination.
Time frame: After 30 minutes rest, before performing the exercise.
Power Doppler ultrasound examination is used.
Microcirculation around the tendon examination.
Time frame: After 30 minutes rest, before performing the exercise.
Oxygen to see (spectrophotometry and laser Doppler) will be used.
3 secondary outcomes
Tendon thickness measurements.
Time frame: 10 minutes after performing the exercise.
Tendon vascularisation examination.
Time frame: 10 minutes after performing the exercise.
Microcirculation around the tendon examination.
Time frame: 10 minutes after performing the exercise.
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 19 Nov 2021.
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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.
Ann Cools, MD, PhD principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric exercise in people with Rotator Cuff Tendinopathy, run by University Ghent at 1 site in Belgium.
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 10 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 19 Nov 2021. 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 Belgium. 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?
Tendon thickness measurement (time frame: After 30 minutes rest, before performing the exercise.). 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?
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 19 Nov 2021.