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

This study is not yet open for participant recruitment.
Verified April 2013 by Bispebjerg Hospital
Sponsor:
Collaborator:
The Danish Medical Research Council
Information provided by (Responsible Party):
Mette Hansen, Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT01834989
First received: April 16, 2013
Last updated: NA
Last verified: April 2013
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Tendinopathy
Drug: Insulin-like growth factor I
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Training and Local Infusion of Insulin-like Growth Factor-I and Training on Tendon Structure in Patients With Patellar Tendinopathy

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Tendon structure [ Time Frame: After 12 weeks intervention (tendon biopsy) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tendon Pain [ Time Frame: 1 year (before and after 12 weeks intervention and 1 year after intervention start) ] [ Designated as safety issue: No ]
    questionnaire


Estimated Enrollment: 40
Study Start Date: April 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01834989

Contacts
Contact: Mette Hansen, Ass. Professor +45 51666551
Contact: Michael Kjaer, Professor +45 35316089 m.kjaer@mfi.ku.dk

Locations
Denmark
Institute of Sports Medicine, Copenhagen Not yet recruiting
Copenhagen, Denmark, 2400
Contact: Michael Kjaer, Professor    +4535316089    m.kjaer@mfi.ku.dk   
Contact: Mette Hansen, Ass. Profes.    +45 51666551    kontakt@mettehansen.nu   
Principal Investigator: Mette Hansen, Ass. Profes.         
Principal Investigator: Michael Kjaer, Professor         
Principal Investigator: Jens Olesen, MD, PhD         
Sponsors and Collaborators
Bispebjerg Hospital
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
  More Information

Additional Information:
No publications provided

Responsible Party: Mette Hansen, Associated Professor, PhD, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01834989     History of Changes
Other Study ID Numbers: H-4-2012-078
Study First Received: April 16, 2013
Last Updated: April 16, 2013
Health Authority: Denmark: Ethics Committee

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Complement Factor I
Mitogens
Insulin
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents

ClinicalTrials.gov processed this record on April 21, 2014