Baxter's Nerve Pulsed Radiofrequency Versus Platelet-Rich Plasma Injection or Both Together as a Treatment Modality of Recalcitrant Plantar Fasciitis: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 75
- 主要终点
- Change from Baseline in Visual Analogue Scale (VAS) Pain Score
研究概览
简要总结
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:
- Baxter's nerve pulsed radiofrequency (PRF), a neuromodulation procedure designed to reduce nerve-related pain without destroying nerve fibers.
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Group A: Baxter's Nerve Pulsed Radiofrequency
Participants receive ultrasound-guided pulsed radiofrequency (PRF) targeting Baxter's nerve (the first branch of the lateral plantar nerve). The procedure is performed under complete aseptic technique at 42°C, with a pulse width of 20 ms, a frequency of 2 Hz, for a duration of 8 minutes.
干预措施: Baxter's Nerve Pulsed Radiofrequency (Procedure)
Group B: Platelet-Rich Plasma Injection
Participants receive an ultrasound-guided injection of 5 mL autologous platelet-rich plasma (PRP) into the diseased plantar fascia. PRP is prepared via a standardized double-spin centrifugation technique and administered under complete aseptic precautions.
干预措施: Autologous Platelet-Rich Plasma Injection (Procedure)
Group C: Combined PRF and PRP Therapy
Participants receive combined treatment consisting of ultrasound-guided Baxter's nerve pulsed radiofrequency (42°C, 20 ms pulse width, 2 Hz for 8 minutes) followed by ultrasound-guided autologous platelet-rich plasma injection (5 mL) into the diseased plantar fascia under complete aseptic technique.
干预措施: Baxter's Nerve Pulsed Radiofrequency (Procedure)
Group C: Combined PRF and PRP Therapy
Participants receive combined treatment consisting of ultrasound-guided Baxter's nerve pulsed radiofrequency (42°C, 20 ms pulse width, 2 Hz for 8 minutes) followed by ultrasound-guided autologous platelet-rich plasma injection (5 mL) into the diseased plantar fascia under complete aseptic technique.
干预措施: Autologous Platelet-Rich Plasma Injection (Procedure)
结局指标
主要结局
Change from Baseline in Visual Analogue Scale (VAS) Pain Score
时间窗: Baseline and 6 months post-intervention
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.
次要结局
未报告次要终点
研究者
Noreen Ahmed Hamza Mohammed
Resident
Assiut University