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

NCT ID: NCT01834989

Last Updated: 2020-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2020-12-01

Brief Summary

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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

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

Conditions

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Tendinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Insulin-like growth factor I

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

Group Type ACTIVE_COMPARATOR

Insulin-like growth factor I

Intervention Type DRUG

Placebo injections

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Insulin-like growth factor I

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Saline Injections

Eligibility Criteria

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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

* corticosteroid injection within the last 12 months
* Knee operation
* Knee osteoarthritis
* Diabetes
* Smoking
* Body mass index \>30
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Danish Medical Research Council

OTHER

Sponsor Role collaborator

Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mette Hansen

Associated Professor, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Kjaer, Professor

Role: PRINCIPAL_INVESTIGATOR

Institute of Sports Medicine, Copenhagen, Bispebjerg Hospital, 2400 Copenhagen, Denmark

Mette Hansen, PhD

Role: PRINCIPAL_INVESTIGATOR

Section of Sport Science, Department of Public Health, Aarhus University, Dalgas Avenue 4, 8000 Aarhus C, Denmark

Jens Olesen, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Sports Medicine, Copenhagen, Bispebjerg Hospital, 2400 Copenahagen, Denmark

Locations

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Institute of Sports Medicine, Copenhagen

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 34138667 (View on PubMed)

Related Links

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http://www.ismc.dk

Study location

Other Identifiers

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H-4-2012-078

Identifier Type: -

Identifier Source: org_study_id

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