Mechanisms Behind Development of Tendinopathy

NCT02797925 | Unknown DMC

• 1 other identifier: BBH-128
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

There has been an increasing amount of musculoskeletal injuries the past decades and overused tendons represents a major problem both for leisure and occupational activities. A full understanding of the pathophysiology of tendinopathy is very sparse and especially the early events in tendinopathy remains unexplained. In this phd study the investigators will investigate early changes in tendon tissue overloading and development of tendinopathy. The investigators will investigate sports-active individuals with recently developed tendinopathy with regards to symptoms (pain, function), tendon morphology (ultrasonography, MRI and electron microscopy), tendon mechanical properties (ultrasonography strain), tissue molecular biology (expression and content of matrix proteins), inflammation (activity of inflammatory pathways) and vascularization (Doppler and contrast enhancement US). The investigators hypothesize a coupling between early symptoms and inflammatory activity, followed by structural changes and altered mechanical properties. The investigation will indicate what symptoms and what tendon related determined measurements are primary for disease development ("tendinopathy blue prints") and should be regarding vital in prevention of tendinopathy.

Conditions

Tendinopathy

Keywords

Achilles tendon; Patella tendon; Inflammation; Edema; Clinical; Structural

Outcome Measures

Primary Outcomes (1)

• Investigate the timespan of inflammation from acute phase to resolution in tendinopathy

  Markers for inflammation includes tendon thickness, vascularization, inflammatory mRNA leves, inflammatory protein signals and mechanical properties of tendon.

  3 months

Secondary Outcomes (6)

• Measure tendon thickness in mm (anterior-posterior) on ultrasound

  3 months

• Measure TNF-alpha mRNA levels in patella biopsies as ratio to GAPDH

  3 months

• Measure the tendon region with maximal vascularization on ultrasound doppler signal based on visual impression from the investigators

  3 months

• IHC stain for TNF-alpha protein signal in patella biopsies with specific antibodies

  3 month

• Measure tendon mechanical properties with ultrasound isometric

  3 months

Study Arms (2)

Tendinopathy

Long slow strength training for 3 months that are performed at home or gym. Participants receive initial guidance to the exercises from a physiotherapist assigned to Bispebjerg H.

Other: Training

Healthy

No intervention. No training

Interventions

Training OTHER

Long slow strength training of the tendon for 3 months to improve function

Also known as: Long slow strength training

Tendinopathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Physical active participants over 18 years old, both men and women. The term physical active refers to any kind of sport and not only running. Participants with pain in either Achilles or patellar tendon on one leg. Healthy participants must be symptom free and not have any diseases at all.

You may qualify if:

• Marked tendon related pain in association with exercise on one leg
• Soreness during physical examination of patella or/and Achilles tendon upon palpation
• Demonstrate an ultrasonographic (US) thickening of the tendon (2 mm larger on the affected side vs the contralateral un-symptomatic side in the anterior-posterior projection)

You may not qualify if:

• Surgery in Achilles and/or patella tendon
• History of Achilles and/or patella tendinopathy
• Received any form of injection in Achilles and/or patella tendon
• Lately have infection around Achilles and/or patella tendon

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• University of Copenhagen: collaborator

Study Sites (1)

Bispebjerg Hospital

Copenhagen, Kbh NV, 2400, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, plasma and tissue.

MeSH Terms

Conditions

Tendinopathy; Inflammation; Edema

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Michael Kjær, Professor

  Clinical Medicine

  STUDY DIRECTOR

Central Study Contacts

Peter Tran, Doctor

CONTACT

+45 27428164; Tesinac2016@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, phd student

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: June 14, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2020
• Last Updated: January 19, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)