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

Tendinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03848598
• Other study ID #: SBogaerts
• Status: Not yet recruiting
• Start date: August 2019
• Est. completion date: July 2020

Study information

• Verified date: February 2019
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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".

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: July 2020
• Est. primary completion date: January 2020
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Tendinopathy

Intervention

Diagnostic Test:
• Evaluation of local tendon deformation
Ultrasound-based speckle tracking to evaluate the local tendon tissue displacement during isometric exercise.

Locations

Country	Name	City	State
Belgium	University Hospitals	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local tendon tissue displacement in three layers of the tendon (deep, middle and superficial layer); as measured by ultrasound-based speckle tracking	Millimeter	Immediately during isometric exercise
Secondary	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)	Immediately during isometric exercise