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

Patellar Tendinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03096067
• Other study ID #: BBH131
• Status: Completed
• Phase: N/A
• Start date: March 29, 2017
• Est. completion date: October 1, 2021

Study information

• Verified date: March 2022
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Randomized controlled intervention study with one year follow-up

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 1, 2021
• Est. primary completion date: June 25, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Jumper's Knee
• Patellar Tendinopathy
• Tendinopathy

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Physical and Occupational Therapy / Institute of Sports Medicine Copenhagen, Bispebjerg Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	Tendon thickness and Doppler activity	Measured by ultrasound	0,6,12 wks + 1 yr follow up + Long-term follow-up (2-4 yr)
Secondary	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)
Secondary	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
Secondary	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
Secondary	Muscle strength	Maximal muscle strength of the knee extensors is obtained during a maximal voluntary contractions	0 and 12 wks
Secondary	Tendon dimensions and structure	Measured by MRI	0 and 12 wks
Secondary	Treatment satisfaction	Questionnaire	12 wks + 1 yr follow-up + Long-term follow-up (2-4 yr)