Chronic midportion Achilles tendinopathy
Conditions
Interventions
Trade Name: Natrium Chloride
Product Name: Natrium Chloride
Product Code: 5/13593960/1110
Pharmaceutical Form: Solution for injection
IN
Sponsors
Medisch Centrum Haaglanden
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.; Timepoint(s) of evaluation of this end point: T1 = 0 weeks T2 = 2 weeks T3 = 6 Weeks T4 = 12 weeks T5 = 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The painDETECT questionnaire. - Degree of neovascularisation (determined with standarised Power Doppler Ultrasonography examination) - Subjective patient satisfaction (excellent / good / fair / poor) - 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) - Time to return to full training in desired sport. - Compliance to the exercise programme. ; Timepoint(s) of evaluation of this end point: T1 = 0 weeks T2 = 2 weeks T3 = 6 Weeks T4 = 12 weeks T5 = 24 weeks | — |
Countries
Netherlands
Contacts
Public ContactAfdeling Sportgeneeskunde
Medisch Centrum Haaglanden
Outcome results
None listed