Ultrasound-Guided Pulsed Radiofrequency Added to Perineural Steroid Injection Versus Perineural Steroid Injection Alone in the Treatment of Tarsal Tunnel Syndrome: A Prospective, Randomized, Double-Blind, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Change from Baseline in Pain Severity on the Visual Analogue Scale (VAS) at 6 Months
研究概览
简要总结
Tarsal tunnel syndrome (TTS) is an entrapment neuropathy caused by compression of the posterior tibial nerve at the ankle, resulting in pain, numbness, and tingling sensations in the heel and sole of the foot. Perineural steroid injections under ultrasound guidance are commonly used for conservative management to decrease inflammation and relieve pressure. Pulsed radiofrequency (PRF) is a minimally invasive neuromodulatory technique that delivers electrical pulses to alter pain transmission and promote tissue healing without damaging the nerve structure.
The objective of this prospective, randomized, double-blind clinical trial is to determine whether combining ultrasound-guided pulsed radiofrequency with perineural steroid injection provides superior pain relief, improved foot function, and higher patient satisfaction compared to perineural steroid injection alone in patients with mild-to-moderate tarsal tunnel syndrome.
A total of 50 adult participants will be randomly allocated to one of two study groups:
- Group A (Active PRF + Steroid Injection): Participants receive ultrasound-guided pulsed radiofrequency applied adjacent to the posterior tibial nerve for 8 minutes (480 seconds), followed immediately by a perineural injection of 10 mL solution containing triamcinolone acetonide, dextrose 5%, and lidocaine 1%.
- Group B (Sham PRF + Steroid Injection): Participants undergo identical ultrasound-guided needle positioning and sensory/motor stimulation testing, followed by 8 minutes of sham radiofrequency (generator switched off), and then receive the identical 10 mL perineural steroid injection.
Participants will be evaluated prior to the procedure and at 2 weeks, 1 month, 3 months, and 6 months post-intervention to assess pain severity (Visual Analogue Scale), foot function and disability (Foot Function Index), global impression of recovery, and any procedure-related side effects or complications.
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
- •Adult patients aged 18 to 65 years old.
- •Clinical diagnosis of idiopathic tarsal tunnel syndrome (TTS).
- •Abnormal electrophysiological study confirming mild-to-moderate TTS.
- •Pain or paresthesia in the posterior tibial nerve distribution persisting for more than 6 months and refractory to conservative therapy (e.g., vitamin B complex, NSAIDs, oral steroids, or night splints).
- •Positive Tinel's sign and/or positive triple compression test.
- •Patient is willing and able to provide written informed consent and attend all scheduled follow-up visits.
排除标准
- •Severe TTS (defined by abductor hallucis muscle atrophy, distal motor latency > 6.5 ms, or absent potentials on electrophysiological testing).
- •Prior ankle or tarsal tunnel injection within the preceding 3 months.
- •Secondary tarsal tunnel syndrome due to systemic diseases (e.g., endocrine disorders, rheumatoid arthritis, gout, or psoriatic arthritis).
- •Concurrent use of systemic corticosteroids or antihistamines.
- •Presence of coagulopathy.
- •Local infection at the planned injection site.
- •Known allergy or hypersensitivity to any of the study medications (triamcinolone acetonide, lidocaine, or dextrose).
- •Pregnancy or lactation.
- •Patient refusal to participate.
研究组 & 干预措施
Group B: Sham Radiofrequency Plus Steroid Injection
Participants undergo the identical ultrasound-guided cannula placement and sensory/motor nerve stimulation protocol, after which the cannula is left in position for 480 seconds with the radiofrequency generator switched off (sham PRF). Following the sham phase, the identical 10 mL perineural injectate (8 mL dextrose 5%, 1 mL triamcinolone acetonide 40 mg, and 1 mL lidocaine 1%) is administered around the posterior tibial nerve.
干预措施: Ultrasound-Guided Perineural Steroid Injection with Sham Radiofrequency (Procedure)
Group A: Pulsed Radiofrequency Plus Steroid Injection
Participants undergo ultrasound-guided pulsed radiofrequency (PRF) adjacent to the posterior tibial nerve using a 22-gauge cannula with a 5 mm active tip (parameters: pulse width 20 ms, frequency 2 Hz, output 45 V, maximum tip temperature 42°C, delivered for 480 seconds in two consecutive 240-second cycles). Following PRF, a 10 mL perineural injectate (8 mL dextrose 5%, 1 mL triamcinolone acetonide 40 mg, and 1 mL lidocaine 1%) is administered around the nerve (approximately 5 mL superficial and 5 mL deep).
干预措施: Ultrasound-Guided Pulsed Radiofrequency and Perineural Steroid (Procedure)
结局指标
主要结局
Change from Baseline in Pain Severity on the Visual Analogue Scale (VAS) at 6 Months
时间窗: Baseline and 6 months post-intervention
Pain intensity is assessed using a 10-cm Visual Analogue Scale (VAS), where 0 indicates "no pain" and 10 indicates "worst pain imaginable" (higher scores indicate worse pain). The change in foot and heel pain and paresthesia from baseline to 6 months post-intervention will be evaluated.
次要结局
未报告次要终点
研究者
Ahmed Bahgat Ramadan Amin
Resident of Anesthesia, Intensive Care, and Pain Management
Assiut University