Baxter's Nerve Pulsed Radiofrequency Versus Platelet-Rich Plasma Injection or Both Together as a Treatment Modality of Recalcitrant Plantar Fasciitis

N/ANot Yet RecruitingNCT07826234

Assiut University75 enrolled

Overview

Plantar fasciitis is a common condition causing chronic heel pain due to degenerative changes in the tissue supporting the arch of the foot. While most patients improve with conservative care such as physical therapy, anti-inflammatory medications, and orthotics, approximately 10% to 20% experience chronic pain that fails to respond to standard measures. In up to 20% of these persistent cases, irritation or entrapment of the first branch of the lateral plantar nerve (Baxter's nerve) also plays a key role in the pain. The purpose of this study is to compare the safety and effectiveness of three ultrasound-guided interventional approaches for treating chronic recalcitrant plantar fasciitis: 1. Baxter's nerve pulsed radiofrequency (PRF), a neuromodulation procedure designed to reduce nerve-related pain without destroying nerve fibers. 2. Platelet-rich plasma (PRP) injection, an autologous blood-derived preparation that delivers natural growth factors to stimulate tissue healing and repair of the plantar fascia. 3. Combined PRF and PRP therapy, addressing both nerve irritation and structural tissue degeneration simultaneously. A total of 75 adult patients aged 18 to 65 years with recalcitrant plantar fasciitis persisting for over 6 months will be randomly assigned into three equal groups (25 patients per group). Participants and independent clinical assessors will be blinded to treatment allocation. Patients will be followed for 6 months to evaluate pain reduction, functional recovery, plantar fascia thickness measured by ultrasound, and procedure safety.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Interventions

Baxter's Nerve Pulsed RadiofrequencyPROCEDURE

Ultrasound-guided pulsed radiofrequency (PRF) targeting Baxter's nerve (the first branch of the lateral plantar nerve) performed under sterile aseptic precautions. Parameters applied: target temperature of 42°C, pulse width of 20 ms, frequency of 2 Hz, for a total duration of 8 minutes.

Autologous Platelet-Rich Plasma InjectionPROCEDURE

Ultrasound-guided administration of 5 mL autologous platelet-rich plasma (PRP) directly into the hypoechoic, thickened portion of the diseased plantar fascia. PRP is isolated using a standardized double-spin centrifugation protocol and injected under complete aseptic conditions.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 to 65 years. * Clinical diagnosis of recalcitrant plantar fasciitis with symptoms persisting for more than 6 months despite conservative treatment. * Failure of conventional non-surgical therapy (including activity modification, NSAIDs, stretching exercises, physiotherapy, and foot orthoses) for at least 3 months. * Morning heel pain localized to the medial calcaneal tubercle. * Local tenderness upon palpation over the medial calcaneal tubercle. * Plantar fascia thickness greater than 4 mm confirmed by musculoskeletal ultrasound. * Ability to understand the study protocol and provide written informed consent. Exclusion Criteria: * Previous surgical intervention for plantar fasciitis * Previous radiofrequency ablation or neuromodulation around the foot or ankle * Platelet-rich plasma (PRP) injection within the previous 6 months * Local corticosteroid injection within the previous 3 months * Evidence of calcaneal stress fracture * Coexisting tarsal tunnel syndrome or history of Baxter's nerve surgery * Systemic inflammatory arthritis (e.g., rheumatoid arthritis, ankylosing spondylitis, reactive arthritis) * Pregnancy * Active local (foot/ankle) or systemic infection * Coagulopathy, bleeding disorders, or ongoing anticoagulant therapy that cannot be safely interruptedMalignancy or severe psychiatric illness * Malignancy or severe psychiatric illness * Inability or refusal to provide informed consent

Outcomes

Primary Outcomes

Change from Baseline in Visual Analogue Scale (VAS) Pain Score

Pain intensity is assessed using the Visual Analogue Scale (VAS), where patients rate their heel pain on a 0 to 10 scale (0 = no pain, 10 = worst imaginable pain). Lower scores indicate less pain and better clinical improvement. The score change will be calculated as the post-treatment score minus the baseline score.

Time frame: Baseline and 6 months post-intervention