Is There a Mechanistic Reason for the Response or Non-response to Isometric Exercise in Tendinopathy?

NCT ID: NCT03848598

Last Updated: 2019-02-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-31
• Study Completion Date: 2020-07-31

Brief 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 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".

Conditions

Tendinopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Responders

Patients suffering from patellar tendinopathy who have complete pain resolution after performing isometric exercises.

Evaluation of local tendon deformation

Intervention Type: DIAGNOSTIC_TEST

Ultrasound-based speckle tracking to evaluate the local tendon tissue displacement during isometric exercise.

Non-responders

Patients suffering from patellar tendinopathy who do not have complete pain resolution after performing isometric exercises.

Evaluation of local tendon deformation

Intervention Type: DIAGNOSTIC_TEST

Ultrasound-based speckle tracking to evaluate the local tendon tissue displacement during isometric exercise.

Interventions

Evaluation of local tendon deformation

Ultrasound-based speckle tracking to evaluate the local tendon tissue displacement during isometric exercise.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• previous treatment for patellar tendinopathy
• rupture of patellar tendon on ultrasound
• unclear differential diagnosis with patellofemoral pain
• concomitant neuromuscular disorders

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Stijn Bogaerts

Resident staff member Physical & Rehabilitation Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospitals

Leuven, Vlaams-Brabant, Belgium

Countries

Belgium

Facility Contacts

Stijn Bogaerts

Role: primary

Other Identifiers

SBogaerts

Identifier Type: -

Identifier Source: org_study_id