Patellar Tendinopathy - The Effect of Load Magnitude in Exercise-based Treatment

Not Applicable

Completed

• Conditions: Patellar Tendinopathy; Jumper's Knee

• Registration Number: NCT03096067
• Lead Sponsor: Bispebjerg Hospital

Brief Summary

The purpose of this project is to investigate if the magnitude of a loading based 12 weeks rehabilitation regime for patellar tendinopathy influence the clinical outcome, tendon structure and function.

The investigators hypothesize that a greater magnitude (90% of 1RM) of loading will yield a more positive clinical outcome, tendon structure and function in patients with patellar tendinopathy compared to a lower magnitude of loading (55% of 1 RM) when total exercise volume is equal in both groups.

Detailed Description

Randomized controlled intervention study with one year follow-up

Study Timeline

• Study First Submitted: 2017-03-17
• Study First Submitted QC: 2017-03-24
• Study Start: 2017-03-29
• Study First Posted: 2017-03-30
• Primary Completion: 2019-06-25
• Study Completion: 2021-10-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 44

Inclusion Criteria

• Uni- or bilateral patellar tendinopathy
• Symptoms > 3 months
• Ultrasonographical tendon swelling
• Ultrasonographical hypo-echoic area with doppler
• BMI 18.5-30

Exclusion Criteria

• Patellar tendinopathy > 12 month
• Previous knee surgery
• Confounding diagnosis to the knee joint
• Diabetes or arthritis
• Previous corticosteroid injection for patellar tendinopathy
• Smoking
• Being elite volleyball players

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline Victorian Institute of Sports Assessment - Patella Questionnaire (VISA-P) at 12 wks	0-12 wks	Patient reported outcome regarding symptoms, function and the ability to participate in sports

Secondary Outcome Measures

Name	Time	Method
Pain rating on numeric rating scale (NRS) and activity level of sporting activities (h/wk)	0,6,12 wks + 1 yr follow up + Long-term follow-up (2-4 yr)	Questionnaire
Mechanical properties	0 and 12 wks	Synchronized tendon elongation with the use of ultrasonography along with force measures, will be used during voluntary contractions to determine mechanical properties
Victorian Institute of Sports Assessment - Patella Questionnaire (VISA-P)	0 and 6 wks + 1 yr follow up + Long-term follow-up (2-4 yr)	Patient reported outcome regarding symptoms, function and the ability to
Tendon thickness and Doppler activity	0,6,12 wks + 1 yr follow up + Long-term follow-up (2-4 yr)	Measured by ultrasound
Treatment satisfaction	12 wks + 1 yr follow-up + Long-term follow-up (2-4 yr)	Questionnaire
Single-leg decline squat (SLDS) test	0,6, 12 wks + 1 yr follow up + Long-term follow-up (2-4 yr)	A reliable patellar tendon pain provocation test, will be used to assess pain during function
Jump test	0 and 12 wks	Squat jump and Counter movement Jump will be used to assess patellar tendinopathy caused functional deficits on the injured site compared with the non-injured site
Muscle strength	0 and 12 wks	Maximal muscle strength of the knee extensors is obtained during a maximal voluntary contractions
Tendon dimensions and structure	0 and 12 wks	Measured by MRI

Trial Locations

Locations (1)

Department of Physical and Occupational Therapy / Institute of Sports Medicine Copenhagen, Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark