Tendinopathy
Conditions
Keywords
Achilles tendon, isometric muscle training, competitive sports, strength training, eccentric exercise, isometric exercise, chronic condition, regeneration, tendon, tendon properties, tendinopathy, tendinosis, intervention, training load, high performance sports
Brief summary
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.
Detailed description
This research project was funded by means of the Bundesinstitut für Sportwissenschaft based on a resolution of the German Federal Parliament.
Interventions
OTHERIsometric exercise
OTHEREccentric exercise
Sponsors
Charite University, Berlin, Germany
Humboldt-Universität zu Berlin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphological tendon properties, Tendon vascularization level | 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). |
| Morphological tendon properties, Tendon cross sectional area (CSA) | 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. |
| Mechanical tendon properties, Tendon stiffness | 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) |
| Mechanical tendon properties, Modulus | 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) |
| Morphological tendon properties, Tendon length | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical functional score | At baseline, 12 weeks and six months after | Victorian Institute of Sport (VISA) - Achilles (A) questionnaire scores from 0 points to 100 points. |
| Interleukin 6 level | At baseline and 12 weeks after | Interleukin 6 (IL- 6) detection in the blood plasma is measured in picogram per milliliter (pg/ml) unit. |
| Functional tendon properties, Ground contact time | 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). |
| Functional tendon properties, Maximum jump height | 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) |
| Pain level via Visual Analogue Scale (VAS) | 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. |
Countries
Germany
Outcome results
None listed