Patellar Tendinopathy - Effect of Training and Enhancement of the Collagen Synthesis by Insulin-like Growth Factor-I (IGF-I)

July 28, 2020 updated by: Mette Hansen, Bispebjerg Hospital

Effect of Training and Local Infusion of Insulin-like Growth Factor-I and Training on Tendon Structure in Patients With Patellar Tendinopathy

The purpose of the study is to test the hypothesis that stimulation of the synthesis of new structural tendon proteins combined with training improve the tendon structure in patients with chronic knee tendon pain.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Randomized controlled intervention study: 12 weeks intervention period with training and injections of saline or Insulin-Like growth factor I. One year follow-up

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2400
        • Institute of Sports Medicine, Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • chronic patellar tendinopathy (> 3 months)
  • anterior-posterior thickening of the tendon (1 mm compared to mid-tendon)
  • hypo-echoic area with enhanced vascularization

Exclusion Criteria: injection

  • corticosteroid injection within the last 12 months
  • Knee operation
  • Knee osteoarthritis
  • Diabetes
  • Smoking
  • Body mass index >30

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Insulin-like growth factor I
3 injection (1 mg), once a week the first 3 weeks of the 12 weeks of intervention
Drug: Insulin-like growth factor I
Placebo Comparator: Placebo injections
3 Injections of saline into the patellar tendon 3 times during the first 3 weeks of the 12 weeks interventions period
Drug: Placebo
Other Names:
  • Saline Injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tendon structure
Time Frame: After 12 weeks intervention (tendon biopsy)
After 12 weeks intervention (tendon biopsy)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tendon Pain
Time Frame: 1 year (before and after 12 weeks intervention and 1 year after intervention start)
questionnaire
1 year (before and after 12 weeks intervention and 1 year after intervention start)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Collaborators

The Danish Medical Research Council

Investigators

  • Principal Investigator: Michael Kjaer, Professor, Institute of Sports Medicine, Copenhagen, Bispebjerg Hospital, 2400 Copenhagen, Denmark
  • Principal Investigator: Mette Hansen, PhD, Section of Sport Science, Department of Public Health, Aarhus University, Dalgas Avenue 4, 8000 Aarhus C, Denmark
  • Principal Investigator: Jens Olesen, PhD, Institute of Sports Medicine, Copenhagen, Bispebjerg Hospital, 2400 Copenahagen, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2013

Primary Completion (Actual)

February 1, 2017

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

April 16, 2013

First Submitted That Met QC Criteria

April 16, 2013

First Posted (Estimate)

April 18, 2013

Study Record Updates

Last Update Posted (Actual)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 28, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-4-2012-078

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tendinopathy

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe