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Completed

NCT Number: NCT03096067

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

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.

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Key information

Conditions

Patellar Tendinopathy Jumper's Knee

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Copenhagen, 2400, Denmark

About this study

Randomized controlled intervention study with one year follow-up

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heavy slow resistance training

Other

Resistance training for knee extensors. The exercise will be performed at 90% of 1 RM and slowly (6 s/repetition).

Moderate slow resistance training

Other

Resistance training for knee extensors. The exercise will be performed at 55% of 1 RM and slowly (6 s/repetition).

Primary outcomes

  1. Change from baseline Victorian Institute of Sports Assessment - Patella Questionnaire (VISA-P) at 12 wks

    Time frame: 0-12 wks

    Patient reported outcome regarding symptoms, function and the ability to participate in sports

Secondary outcomes

  1. Victorian Institute of Sports Assessment - Patella Questionnaire (VISA-P)

    Time frame: 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

  2. Pain rating on numeric rating scale (NRS) and activity level of sporting activities (h/wk)

    Time frame: 0,6,12 wks + 1 yr follow up + Long-term follow-up (2-4 yr)

    Questionnaire

  3. Tendon thickness and Doppler activity

    Time frame: 0,6,12 wks + 1 yr follow up + Long-term follow-up (2-4 yr)

    Measured by ultrasound

  4. Single-leg decline squat (SLDS) test

    Time frame: 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

  5. Jump test

    Time frame: 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

  6. Mechanical properties

    Time frame: 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

  7. Muscle strength

    Time frame: 0 and 12 wks

    Maximal muscle strength of the knee extensors is obtained during a maximal voluntary contractions

  8. Tendon dimensions and structure

    Time frame: 0 and 12 wks

    Measured by MRI

  9. Treatment satisfaction

    Time frame: 12 wks + 1 yr follow-up + Long-term follow-up (2-4 yr)

    Questionnaire

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
Mar 30, 2017
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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