Clinical trial NCT03096067: Patellar Tendinopathy - The Effect of Load Magnitude in Exercise-based Treatment
Official title: Treatment of Patellar Tendinopathy; Influence of Load Magnitude on Clinical Outcome, Tendon Structure and Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellar Tendinopathy
Jumper's Knee
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2017-03-30
Enrollment: 44
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline Victorian Institute of Sports Assessment - Patella Questionnaire (VISA-P) at 12 wks
timeFrame: 0-12 wks
Secondary outcomes:
measure: Victorian Institute of Sports Assessment - Patella Questionnaire (VISA-P)
timeFrame: 0 and 6 wks + 1 yr follow up + Long-term follow-up (2-4 yr)
measure: Pain rating on numeric rating scale (NRS) and activity level of sporting activities (h/wk)
timeFrame: 0,6,12 wks + 1 yr follow up + Long-term follow-up (2-4 yr)
measure: Tendon thickness and Doppler activity
timeFrame: 0,6,12 wks + 1 yr follow up + Long-term follow-up (2-4 yr)
measure: Single-leg decline squat (SLDS) test
timeFrame: 0,6, 12 wks + 1 yr follow up + Long-term follow-up (2-4 yr)
measure: Jump test
timeFrame: 0 and 12 wks
measure: Mechanical properties
timeFrame: 0 and 12 wks
measure: Muscle strength
timeFrame: 0 and 12 wks
measure: Tendon dimensions and structure
timeFrame: 0 and 12 wks
measure: Treatment satisfaction
timeFrame: 12 wks + 1 yr follow-up + Long-term follow-up (2-4 yr)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Physical and Occupational Therapy / Institute of Sports Medicine Copenhagen, Bispebjerg Hospital
Study officials:
affiliation: Bispebjerg Hospital, University of Copenhagen
name: Peter Magnusson, Professor
role: STUDY_DIRECTOR
affiliation: Bispebjerg Hospital
name: Anne-Sofie Agergaard, Phd.Student
role: PRINCIPAL_INVESTIGATOR
References:
citation: Agergaard AS, Svensson RB, Malmgaard-Clausen NM, Couppe C, Hjortshoej MH, Doessing S, Kjaer M, Magnusson SP. Clinical Outcomes, Structure, and Function Improve With Both Heavy and Moderate Loads in the Treatment of Patellar Tendinopathy: A Randomized Clinical Trial. Am J Sports Med. 2021 Mar;49(4):982-993. doi: 10.1177/0363546520988741. Epub 2021 Feb 22.