Treatment of Patellar Tendinopathy

• ClinicalTrials.gov Identifier: NCT03096067
• Recruitment Status: Completed
• First Posted: March 30, 2017
• Last Update Posted: July 28, 2020
• Sponsor: Bispebjerg Hospital
• Information provided by (Responsible Party): Anne-Sofie Andersen, Bispebjerg Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Patellar Tendinopathy; Jumper's Knee	Other: Heavy slow resistance training; Other: Moderate slow resistance training	Not Applicable

Detailed Description:

Randomized controlled intervention study with one year follow-up

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Treatment of Patellar Tendinopathy; Influence of Load Magnitude on Clinical Outcome, Tendon Structure and Function
• Actual Study Start Date: March 29, 2017
• Actual Primary Completion Date: June 25, 2019
• Actual Study Completion Date: June 25, 2019

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

1. Victorian Institute of Sports Assessment - Patella Questionnaire (VISA-P) [ Time Frame: 0 and 6 wks + 1 yr follow up ]
   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 ]
   Questionnaire
3. Tendon thickness and Doppler activity [ Time Frame: 0,6,12 wks + 1 yr follow up ]
   Measured by ultrasound
4. Single-leg decline squat (SLDS) test [ Time Frame: 0,6, 12 wks + 1 yr follow up ]
   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 ]
   Questionnaire

Eligibility Criteria

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

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

Contacts and Locations

Locations

Denmark

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

Copenhagen, Denmark, 2400

Sponsors and Collaborators

Bispebjerg Hospital

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Agergaard AS, Svensson RB, Malmgaard-Clausen NM, Couppé 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.

• Responsible Party: Anne-Sofie Andersen, PhD Student, MSc. in Physiotherapy, PT, Bispebjerg Hospital
• ClinicalTrials.gov Identifier: NCT03096067
• Other Study ID Numbers: BBH131
• First Posted: March 30, 2017
• Last Update Posted: July 28, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries