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

Treatment of Patellar Tendinopathy; Influence of Load Magnitude on Clinical Outcome, Tendon Structure and Function

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.

Study Overview

• Status: Completed
• Conditions: Jumper's Knee; Patellar Tendinopathy
• Intervention / Treatment: Other: Heavy slow resistance training; Other: Moderate slow resistance training

Detailed Description

Randomized controlled intervention study with one year follow-up

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2400
    • Department of Physical and Occupational Therapy / Institute of Sports Medicine Copenhagen, Bispebjerg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Heavy slow resistance group; Heavy slow resistance training. Three times weekly for 12 weeks.	Other: Heavy slow resistance training; Resistance training for knee extensors. The exercise will be performed at 90% of 1 RM and slowly (6 s/repetition).
Experimental: Moderate slow resistance group; Moderate slow resistance training. Three times weekly for 12 weeks.	Other: Moderate slow resistance training; Resistance training for knee extensors. The exercise will be performed at 55% of 1 RM and slowly (6 s/repetition).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Investigators: Study Director: Peter Magnusson, Professor, Bispebjerg Hospital, University of Copenhagen; Principal Investigator: Anne-Sofie Agergaard, Phd.Student, Bispebjerg Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2017
• Primary Completion (Actual): June 25, 2019
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: March 17, 2017
• First Submitted That Met QC Criteria: March 24, 2017
• First Posted (Actual): March 30, 2017

Study Record Updates

• Last Update Posted (Actual): March 8, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: BBH131

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No