HAT-study
- Conditions
- Chronic midportion Achilles tendinopathyTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2015-000180-13-NL
- Lead Sponsor
- Medisch Centrum Haaglanden
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
- Age 18-70 years.
- Clinical diagnosis of chronic midportion Achilles tendinopathy: Painfull swelling of the Achilles tendon, 2-7 cm proximal to it’s calcaneal insertion.
- Non-response to eccentric excercise program for 6 weeks.
- Painfull Achilles tendon for more than 2 months.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Clinical suspicion of insertional disorders.
- Clinical suspicion of Achilles tendon rupture.
- Clinical suspicion of plantar flexor tenosynovitis.
- Clinical suspicion of peroneal tendinopathy or subluxation.
- Clicical suspicion of sural nerve pathology.
- Condition of the Achilles tendon caused by medication, such as quinolones and statins.
- Known to have the following disorders: spondylarthropathy, gout, hyperlipidemia, rheumatoid arthritis and sarcoïdosis.
- Inability to perform a heavy load eccentric exercise program.
- Recently prescribed drugs (within 2 years) with a putative effect on symptoms and tendon healing (quinolone antibiotics, corticosteroids).
- Presence of pregancy.
- Previous Achilles tendon rupture.
- Patient has received surgical intervention for his injury.
- A medical condition that would affect safety of injection (e.g. peripheral vascular disease, use of anticoagulant medication)
- Inability to give informed consent.
- Participation in other concomitant treatment programs.
- Patient has already one side included in this study.
- Patient does not wish, for whatever reason, to undergo one of the two treatments.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the value of High-Volume Image-Guided Injections in patiënts with chronic midportion Achilles tendinopathie.;Secondary Objective: To investigate the effect of the High-Volume Image-Guided Injections on the neovascularisation surrounding the Achilles tendon.;Primary end point(s): Our primary outcome measurement is the VISA-A score. This measures pain, function and activity level. It is validated en reliable for the chronic Achilles tendinopathy.;<br> Timepoint(s) of evaluation of this end point: T1 = 0 weeks<br> T2 = 2 weeks<br> T3 = 6 Weeks<br> T4 = 12 weeks<br> T5 = 24 weeks<br>
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): - The painDETECT questionnaire.<br> - Degree of neovascularisation (determined with standarised Power Doppler Ultrasonography examination)<br> - Subjective patient satisfaction (excellent / good / fair / poor)<br> - Return to sports (Return to desired sport on pre-injury level / return to desired sport but on a lower level / return to sports but not desired sport / no return to sports)<br> - Time to return to full training in desired sport.<br> - Compliance to the exercise programme.<br> ;<br> Timepoint(s) of evaluation of this end point: T1 = 0 weeks<br> T2 = 2 weeks<br> T3 = 6 Weeks<br> T4 = 12 weeks<br> T5 = 24 weeks<br>