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

Bispebjerg Hospital

Status and phase: Unknown; Early Phase 1

Conditions: Tendinopathy

Treatments: Drug: Insulin-like growth factor I; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01834989

H-4-2012-078

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Insulin-like growth factor I

Active Comparator group

Description:

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

Treatment:

Drug: Insulin-like growth factor I

Placebo injections

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo