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

NCT05622279 | Completed

• 1 other identifier: RC22_0153
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Plantar Fascitis

Keywords

Plantar fasciitis, needle tenotomy, ultrasound, platelet rich plasma

Outcome Measures

Primary Outcomes (1)

• To evaluate the evolution of plantar pain after treatment combining needle tenotomy and PRP injection in refractory plantar fasciitis.

  VAS pain at activity

  6 months

Secondary Outcomes (6)

• Evaluate the tolerance of the procedure

  6 weeks, 3 months, 6 months

• Evaluate the acceptability of the procedure

  6 weeks, 3 months, 6 months

• Evaluate the evolution of the functional discomfort

  6 weeks, 3 months, 6 months

• Evaluate the return to sports activities

  6 weeks, 3 months, 6 months

• Evaluate the evolution of pain when pressing the insertion of the plantar fascia

  6 weeks, 3 months, 6 months

Study Arms (1)

percutaneous tenotomy + PRP

EXPERIMENTAL

There will be a single arm receiving the treatment being evaluated

Procedure: Percutaneous tenotomy + PRP

Interventions

Percutaneous tenotomy + PRP PROCEDURE

The patients will receive a percutaneous ultrasound-guided treatment including a needle tenotomy followed by a PRP injection in the plantar fasciitis.

percutaneous tenotomy + PRP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Nantes University Hospital: lead
• Regen Lab SA: collaborator

Study Sites (1)

CHU de Nantes

Nantes, France, 44000, France

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The VAS pain data will be compared between before the procedure and 6 months after using a Wilcoxon ranks test for paired data.

Study Record Dates

• First Submitted: November 13, 2022
• First Posted: November 18, 2022
• Study Start: January 9, 2023
• Primary Completion: August 11, 2025
• Study Completion: August 11, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)