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OpenTrials
Completed

NCT Number: NCT02732782

Effectiveness of Isometric vs. Eccentric Exercise in Chronic Achilles Tendinopathy

This is a prospective single blinded randomised controlled trial with a 12-week intervention period and a half-year follow-up period. The main purpose is to determine the effects of isometric exercise on mechanical, morphological and functional tendon properties versus eccentric exercise in chronic Achilles tendinopathy.

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Key information

Conditions

Tendinopathy Chronic Disease Disease Attributes Muscular Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tendon Injuries Wounds and Injuries

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Humboldt Universität zu Berlin, Institut für Bewegungswissenschaften, Department Movement Sciences

Berlin, 10117, Germany

About this study

This research project was funded by means of the "Bundesinstitut für Sportwissenschaft" based on a resolution of the German Federal Parliament.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic (3 months or more) condition of unilateral Achilles tendinopathy confirmed by a medical doctor based on ultrasound
  • age 18-60
  • male
  • VISA-A Score of at least 80

Exclusion criteria

  • bilateral tendinopathy
  • any systemic or inflammatory diseases (i. e. Diabetes, Arthritis)
  • surgery on lower extremities in the past
  • corticoid injections in the last 12 months

Treatment and study plan

Isometric exercise

Other

Eccentric exercise

Other

Primary outcomes

  1. Morphological tendon properties, Tendon cross sectional area (CSA)

    Time frame: At baseline and 12 weeks after

    Equipment Magnetic resonance imaging (MRI) (0.25 T MR Scanner (Esaote, G-Scan, Italy), T1-Gewichtung, 3D HYCE (GR) Sequency, TR 10 ms, TE 5 ms, flip angle 80°, layer thickness 3 mm, 1 Anregung) Software OsiriX (Pixmeo SARL, Version 2.5.1., Schweiz)

    Tendon thickness / cross sectional area (CSA) in square millimeter (mm²) through MRI, manually outlined via Software OsiriX (Pixmeo SARL, Version 2.5.1., Schweiz). The mean value of three measurements of the same image will be used for analysis. In order to demonstrate local changes within the tendon, CSA will be shown in 10% intervals relative to the total length of the tendon.

  2. Mechanical tendon properties, Tendon stiffness

    Time frame: At baseline and 12 weeks after

    Equipment Dynamometer (Biodex System 3, Medical Systems Inc., USA), optical motion capture system with eight cameras with a frequency of 250 Hertz (Hz) (Vicon Nexus, version 1.7.1., Vicon Motion Systems, UK), electromyography (Myon m320RX, Myon AG, Schweiz) and a linear ultrasound (7.5 Megahertz (MHz), ESAOTE MyLab 60)

    Tendon stiffness in Newton per mm (N/mm) with support of tendon force in Newton (N)

  3. Mechanical tendon properties, Modulus

    Time frame: At baseline and 12 weeks after

    Equipment Dynamometer (Biodex System 3, Medical Systems Inc., USA), optical motion capture system with eight cameras with a frequency of 250 Hertz (Hz) (Vicon Nexus, version 1.7.1., Vicon Motion Systems, UK), electromyography (Myon m320RX, Myon AG, Schweiz) and a linear ultrasound (7.5 Megahertz (MHz), ESAOTE MyLab 60)

    Modulus in Pascal (Pa) based on tendon stress (Pa) and tendon elongation in millimeter (mm)

  4. Morphological tendon properties, Tendon length

    Time frame: At baseline and 12 weeks after

    Equipment Magnetic resonance imaging (MRI) (0.25 T MR Scanner (Esaote, G-Scan, Italy), T1-Gewichtung, 3D HYCE (GR) Sequency, TR 10 ms, TE 5 ms, flip angle 80°, layer thickness 3 mm, 1 Anregung) Software OsiriX (Pixmeo SARL, Version 2.5.1., Schweiz)

    Tendon length im millimeter (mm) through MRI, manually outlined via Software OsiriX (Pixmeo SARL, Version 2.5.1., Schweiz).The mean value of three measurements of the same image will be used for analysis.

  5. Morphological tendon properties, Tendon vascularization level

    Time frame: At baseline and 12 weeks after

    Equipment Linear ultrasound (7.5 Megahertz (MHz), ESAOTE MyLab 60) Software Doppler Flow Image Analyser version 1.01

    Vascularization level of the tendon via Color Doppler (CD) ultrasound CD signals will be estimated through the total number of coloured pixels within the area of interest (3x7 centimeters (cm) with the help of Software Doppler Flow Image Analyser version 1.01 (http://www.gtech.dk).

Secondary outcomes

  1. Clinical functional score

    Time frame: At baseline, 12 weeks and six months after

    Victorian Institute of Sport (VISA) - Achilles (A) questionnaire scores from 0 points to 100 points.

  2. Interleukin 6 level

    Time frame: At baseline and 12 weeks after

    Interleukin 6 (IL- 6) detection in the blood plasma is measured in picogram per milliliter (pg/ml) unit.

  3. Functional tendon properties, Ground contact time

    Time frame: At baseline and 12 weeks after

    Drop jumps and counter movement jumps on a three dimensional force plate (AMTI, BP400600-2000, 60x40 cm, 1000 Hz)

    Ground contact time is estimated through ground reaction forces (N or kN).

  4. Functional tendon properties, Maximum jump height

    Time frame: At baseline and 12 weeks after

    Drop jumps and counter movement jumps on a three dimensional force plate (AMTI, BP400600-2000, 60x40 cm, 1000 Hz)

    Maximum jump height is estimated through the vertical impulse / component of the ground reaction force in Newton (N) or Kilo Newton (kN)

  5. Pain level via Visual Analogue Scale (VAS)

    Time frame: At baseline, 12 weeks and six months after

    A Visual Analogue Scale (VAS) for pain reaching from 0mm to 100mm as part of the VISA - A questionnaire.

Sponsors and collaborators

Lead sponsor

Humboldt-Universität zu Berlin

Other

Collaborators

  • Charite University, Berlin, Germany

Registry information

Official study title

Effectiveness of Eccentric Exercise Compared to Isometric Exercise in Athletes With Chronic Achilles Tendinopathy

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Apr 11, 2016
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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