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NCT05622279
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
Conditions: Plantar Fascitis
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 19
Sponsor: Nantes University Hospital
Location: France
Summary
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.
Eligibility Criteria
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 ≥ 4/10Failure of the initial management including physical therapy, adaptation of footwear and local steroid infiltrationPatient 18 years of age or olderPatient affiliated to a social security planPatient able to understand the protocol and having signed an informed informed consentExclusion Criteria :Patients on NSAIDs and refusing to discontinue them 1 week and 1 week after the procedureCorticosteroid infusion at the same lesion site in the last 3 monthsHistory of PRP injection at the same lesion siteTreatment 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 anticoagulantsAny medical condition that may interfere with pain assessmentCurrent hematological disease or in remission for less than 5 years (hematological malignancies, myelodysplasia, autoimmune thrombocytopenia), chemotherapyInfection at the time of inclusion (bacterial infection and/or presence of fever and/or antibiotic treatment)Pregnant or breastfeeding women or those refusing effective contraceptionPatient deprived of liberty or under legal protection (guardianship or curatorship)Patients under court protectionPatients participating in another clinical research protocol involving a drug or medical devicePatients unable to follow the protocol, as determined by the investigatorPatient refusing to participate in the study
Source: ClinicalTrials.gov (NCT05622279). StuddyBuddy aggregates publicly available trial information.