Informations générales (source: ClinicalTrials.gov)

NCT05622279 Statut inconnu
Percutaneous Needle Tenotomy Associated With Platelet-rich Plasma Injection Platelet-rich Plasma in the Treatment of Refractory Plantar Fasciitis: a Pilot Study of the Effect on Pain and Tolerance (ANTILOPE)
Interventional
  • Fasciite
  • Fasciite plantaire
N/A
Nantes University Hospital (Voir sur ClinicalTrials)
janvier 2023
mai 2025
24 mai 2025
There are various treatments for plantar fasciitis, including physical therapy, orthopedic inserts or steroid infiltrations. However, it is estimated that about 20% of patients do not respond to first-line treatment [Rompe, Sports Med Arthrosc Rev, 2009]. It is therefore necessary to be able to integrate new treatments into the management of this condition. The objective of the study is to assess the effect on pain and the safety of the percutaneous ultrasound-guided tenotomy associated with a platelet rich plasma injection to treat refractory plantar fasciitis.
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Etablissements

Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHU de Nantes - 44000 - Nantes - France Christelle Darrieutort Laffite, PH En recrutement Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria :

Patient with chronic inferior heel pain diagnosed as plantar fasciitis plantar fasciitis
evolving for more than 3 months with a pain VAS at activity ≥ 4/10

- Failure of the initial management including physical therapy, adaptation of footwear
and local steroid infiltration

- Patient 18 years of age or older

- Patient affiliated to a social security plan

- Patient able to understand the protocol and having signed an informed informed
consent

Exclusion Criteria :

- Patients on NSAIDs and refusing to discontinue them 1 week and 1 week after the
procedure

- Corticosteroid infusion at the same lesion site in the last 3 months

- History of PRP injection at the same lesion site

- Treatment with antiplatelet agents [Acetylsalicylic acid (Aspegic, Kardegic,
Duoplavin, Resitune, Asasantine), Clopidogrel (Plavix, Duoplavin), Dipyridamole
(Persantine, Cleridium, Asasantine)]

- Coagulation disorders: thrombocytopenia < 150,000 platelets/mm3 - Patients on
curative anticoagulants

- Any medical condition that may interfere with pain assessment

- Current hematological disease or in remission for less than 5 years (hematological
malignancies, myelodysplasia, autoimmune thrombocytopenia), chemotherapy

- Infection at the time of inclusion (bacterial infection and/or presence of fever
and/or antibiotic treatment)

- Pregnant or breastfeeding women or those refusing effective contraception

- Patient deprived of liberty or under legal protection (guardianship or curatorship)

- Patients under court protection

- Patients participating in another clinical research protocol involving a drug or
medical device

- Patients unable to follow the protocol, as determined by the investigator

- Patient refusing to participate in the study