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

Primary Purpose

Tendinopathy

Status
Unknown status
Phase
Early Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Insulin-like growth factor I
Placebo
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Tendinopathy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Sports Medicine, Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Insulin-like growth factor I

Placebo injections

Arm Description

3 injection (1 mg), once a week the first 3 weeks of the 12 weeks of intervention

3 Injections of saline into the patellar tendon 3 times during the first 3 weeks of the 12 weeks interventions period

Outcomes

Primary Outcome Measures

Tendon structure

Secondary Outcome Measures

Tendon Pain
questionnaire

Full Information

First Posted
April 16, 2013
Last Updated
July 28, 2020
Sponsor
Bispebjerg Hospital
Collaborators
The Danish Medical Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT01834989
Brief Title
Patellar Tendinopathy - Effect of Training and Enhancement of the Collagen Synthesis by Insulin-like Growth Factor-I
Acronym
IGF-I
Official Title
Effect of Training and Local Infusion of Insulin-like Growth Factor-I and Training on Tendon Structure in Patients With Patellar Tendinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (Actual)
Primary Completion Date
February 1, 2017 (Actual)
Study Completion Date
December 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
Collaborators
The Danish Medical Research Council

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insulin-like growth factor I
Arm Type
Active Comparator
Arm Description
3 injection (1 mg), once a week the first 3 weeks of the 12 weeks of intervention
Arm Title
Placebo injections
Arm Type
Placebo Comparator
Arm Description
3 Injections of saline into the patellar tendon 3 times during the first 3 weeks of the 12 weeks interventions period
Intervention Type
Drug
Intervention Name(s)
Insulin-like growth factor I
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline Injections
Primary Outcome Measure Information:
Title
Tendon structure
Time Frame
After 12 weeks intervention (tendon biopsy)
Secondary Outcome Measure Information:
Title
Tendon Pain
Description
questionnaire
Time Frame
1 year (before and after 12 weeks intervention and 1 year after intervention start)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Kjaer, Professor
Organizational Affiliation
Institute of Sports Medicine, Copenhagen, Bispebjerg Hospital, 2400 Copenhagen, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mette Hansen, PhD
Organizational Affiliation
Section of Sport Science, Department of Public Health, Aarhus University, Dalgas Avenue 4, 8000 Aarhus C, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jens Olesen, PhD
Organizational Affiliation
Institute of Sports Medicine, Copenhagen, Bispebjerg Hospital, 2400 Copenahagen, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Sports Medicine, Copenhagen
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
34138667
Citation
Olesen JL, Hansen M, Turtumoygard IF, Hoffner R, Schjerling P, Christensen J, Mendias CL, Magnusson PS, Kjaer M. No Treatment Benefits of Local Administration of Insulin-like Growth Factor-1 in Addition to Heavy Slow Resistance Training in Tendinopathic Human Patellar Tendons: A Randomized, Double-Blind, Placebo-Controlled Trial With 1-Year Follow-up. Am J Sports Med. 2021 Jul;49(9):2361-2370. doi: 10.1177/03635465211021056. Epub 2021 Jun 17.
Results Reference
derived
Links:
URL
http://www.ismc.dk
Description
Study location

Learn more about this trial

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

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