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

Early Phase 1

• Conditions: Tendinopathy
• Interventions: Drug: Insulin-like growth factor I; Drug: Placebo

• Registration Number: NCT01834989
• Lead Sponsor: Bispebjerg Hospital

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

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-16
• Study First Submitted QC: 2013-04-16
• Study First Posted: 2013-04-18
• Primary Completion: 2017-02-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-28
• Last Update Posted: 2020-07-29
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insulin-like growth factor I	Insulin-like growth factor I	3 injection (1 mg), once a week the first 3 weeks of the 12 weeks of intervention
Placebo injections	Placebo	3 Injections of saline into the patellar tendon 3 times during the first 3 weeks of the 12 weeks interventions period

Primary Outcome Measures

Name	Time	Method
Tendon structure	After 12 weeks intervention (tendon biopsy)

Secondary Outcome Measures

Name	Time	Method
Tendon Pain	1 year (before and after 12 weeks intervention and 1 year after intervention start)	questionnaire

Trial Locations

Locations (1)

Institute of Sports Medicine, Copenhagen; 🇩🇰 Copenhagen, Denmark