TendinopathyNCT03848598
Is There a Mechanistic Reason for the Response or Non-response to Isometric Exercise in Tendinopathy?
An observational study of Tendinopathy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
In early phase tendinopathy, isometric exercises are seen as ideal to provide pain relief to patients. This approach is mainly based on a paper by Rio et al (2016), where they found that isometric exercises of a certain load magnitude and time (5 repetitions of 45 second hold at 70% of maximum) gave 100% pain relief… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Tendinopathy
- What is being tested?
- Evaluation of local tendon deformation
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2019to Jul 2020
- Phase
- Observational
- 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 45 years
- All sexes
- Adult
Study population: Patients visiting the sports medicine consultation of the University Hospitals and presenting with complaints of patellar tendinopathy will be screened for eligibility.
Who may be able to join
- Clinical diagnosis of patellar tendinopathy, consisting of
- pain located at the proximal part of the patellar tendon
- painful at palpation the proximal part of the patellar tendon
- Numeric Rating Scale > 1/10 with squat on decline (20°) board
Who cannot join
- previous treatment for patellar tendinopathy
- rupture of patellar tendon on ultrasound
- unclear differential diagnosis with patellofemoral pain
- concomitant neuromuscular disorders
Trial locations and contacts
1 site in 1 country.
About this study
In early phase tendinopathy, isometric exercises are seen as ideal to provide pain relief to patients. This approach is mainly based on a paper by Rio et al (2016), where they found that isometric exercises of a certain load magnitude and time (5 repetitions of 45 second hold at 70% of maximum) gave 100% pain relief for 45 minutes in patients with patellar tendinopathy. This then helps patients to perform their more heavy load exercises during rehabilitation, which would otherwise be too painful.
Unfortunately, the study of Rio et al only consisted of 6 participants, and recent papers have contradicted the findings. In Achilles tendinopathy, plantar fasciopathy and lateral elbow tendinopathy, the pain relief was not consistently present, with "responders" and "non-responders" being found in these studies. Also, a study yet to be published (poster at conference), replicating Rio et al, also found a heterogeneous response, debunking the "one size fits all" approach that seemed to work.
Read more
However, in our understanding, isometric exercises do have a crucial role in early tendinopathy management, but the way the exercise is performed, in which position, what magnitude of load, time under tension, … has an important influence. The same protocol (5 repetitions of 45 second hold at 70% of maximum) might lead to big inter-individual differences. Therefore, there might be a mechanistic reason why some patients respond, and others do not.
Fortunately, the P.I. of this current trial application has recently optimized an ultrasound-based method to quantify local tendon deformation during exercises. The main purpose of this trial is therefore to evaluate the local tendon deformation pattern of patients with tendinopathy during isometric exercises and evaluate whether there is an interindividual difference in pattern between "responders" and "non-responders".
- Conditions
- Tendinopathy
- Being tested
- Evaluation of local tendon deformation
- Keywords
- patellar, ultrasound, speckle, isometric
- Medical subject headings
- Tendinopathy, Patella Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of local tendon deformationDiagnostic test
Ultrasound-based speckle tracking to evaluate the local tendon tissue displacement during isometric exercise.
| Study group | Role | What they receive |
|---|---|---|
| Responders | Patients suffering from patellar tendinopathy who have complete pain resolution after performing isometric exercises. Receives: Diagnostic Test: Evaluation of local tendon deformation | |
| Non-responders | Patients suffering from patellar tendinopathy who do not have complete pain resolution after performing isometric exercises. Receives: Diagnostic Test: Evaluation of local tendon deformation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local tendon tissue displacement in three layers of the tendon (deep, middle and superficial layer); as measured by ultrasound-based speckle tracking
Millimeter
Measured: Immediately during isometric exercise
Secondary outcomes (1)
Non-uniform displacement; as measured by ultrasound-based speckle tracking
% (measure for relative displacement of the superficial layer of the tendon versus the deep layer, and then divided by the mean total displacement of the three layers combined)
Measured: Immediately during isometric exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study startAug 2019 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stijn Bogaerts, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848598
- Sponsor's protocol ID
- SBogaerts
- Status last verified
- Feb 2019
- First submitted
- 13 Feb 2019
- Last updated
- 22 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There a Mechanistic Reason for the Response or Non-response to Isometric Exercise in Tendinopathy?
- ClinicalTrials.gov ID
- NCT03848598
- Acronym / sponsor ID
- SBogaerts
- Conditions
- Tendinopathy
- Keywords
- patellar, ultrasound, speckle, isometric
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 21 Feb 2019 (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.
In early phase tendinopathy, isometric exercises are seen as ideal to provide pain relief to patients. This approach is mainly based on a paper by Rio et al (2016), where they found that isometric exercises of a certain load magnitude and time (5 repetitions of 45 second hold at 70% of maximum) gave 100% pain relief for 45 minutes in patients with patellar tendinopathy. This then helps patients to perform their more heavy load exercises during rehabilitation, which would otherwise be too painful.
Unfortunately, the study of Rio et al only consisted of 6 participants, and recent papers have contradicted the findings. In Achilles tendinopathy, plantar fasciopathy and lateral elbow tendinopathy, the pain relief was not consistently present, with "responders" and "non-responders" being found in these studies. Also, a study yet to be published (poster at conference), replicating Rio et al, also found a heterogeneous response, debunking the "one size fits all" approach that seemed to work.
However, in our understanding, isometric exercises do have a crucial role in early tendinopathy management, but the way the exercise is performed, in which position, what magnitude of load, time under tension, … has an important influence. The same protocol (5 repetitions of 45 second hold at 70% of maximum) might lead to big inter-individual differences. Therefore, there might be a mechanistic reason why some patients respond, and others do not.
Fortunately, the P.I. of this current trial application has recently optimized an ultrasound-based method to quantify local tendon deformation during exercises. The main purpose of this trial is therefore to evaluate the local tendon deformation pattern of patients with tendinopathy during isometric exercises and evaluate whether there is an interindividual difference in pattern between "responders" and "non-responders".
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Responders | – | Diagnostic Test: Evaluation of local tendon deformationPatients suffering from patellar tendinopathy who have complete pain resolution after performing isometric exercises. |
| Non-responders | – | Diagnostic Test: Evaluation of local tendon deformationPatients suffering from patellar tendinopathy who do not have complete pain resolution after performing isometric exercises. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients visiting the sports medicine consultation of the University Hospitals and presenting with complaints of patellar tendinopathy will be screened for eligibility.
Key inclusion criteria (4 listed)
- Clinical diagnosis of patellar tendinopathy, consisting of
- pain located at the proximal part of the patellar tendon
- painful at palpation the proximal part of the patellar tendon
- Numeric Rating Scale > 1/10 with squat on decline (20°) board
Key exclusion criteria (4 listed)
- previous treatment for patellar tendinopathy
- rupture of patellar tendon on ultrasound
- unclear differential diagnosis with patellofemoral pain
- concomitant neuromuscular disorders
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 |
|---|---|---|
| Evaluation of local tendon deformationUltrasound-based speckle tracking to evaluate the local tendon tissue displacement during isometric exercise. | Diagnostic test | Non-responders, Responders |
Primary outcome
Local tendon tissue displacement in three layers of the tendon (deep, middle and superficial layer); as measured by ultrasound-based speckle tracking
Time frame: Immediately during isometric exercise
Millimeter
1 secondary outcome
Non-uniform displacement; as measured by ultrasound-based speckle tracking
Time frame: Immediately during isometric exercise
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tendinopathy, run by Universitaire Ziekenhuizen KU Leuven 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Feb 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 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. 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?
Results are not available in the source record.
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?
Local tendon tissue displacement in three layers of the tendon (deep, middle and superficial layer); as measured by ultrasound-based speckle tracking (time frame: Immediately during isometric exercise). 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 Feb 2019.