Ultrasound-Guided Pulsed Radiofrequency Added to Perineural Steroid Injection Versus Perineural Steroid Injection Alone in the Treatment of Tarsal Tunnel Syndrome
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
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.
Przegląd badań
Status
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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). |
Under real-time ultrasound guidance, a 22-gauge, 54-mm radiofrequency cannula with a 5-mm active tip is placed adjacent to the posterior tibial nerve. Sensory (50 Hz, ≤0.5 V) and motor (2 Hz, >0.5 V) stimulation are confirmed, followed by active pulsed radiofrequency (PRF) delivery (parameters: 42°C maximum tip temperature, 45 V, 2 Hz, 20 ms pulse width, for 480 seconds delivered as two consecutive 240-second cycles). Immediately following PRF, a 10 mL solution (8 mL dextrose 5%, 1 mL triamcinolone acetonide 40 mg, and 1 mL lidocaine 1%) is injected through the same cannula around the nerve (5 mL superficial and 5 mL deep). |
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Pozorny komparator: 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. |
Under real-time ultrasound guidance, the cannula is positioned adjacent to the posterior tibial nerve using the identical technique, followed by identical sensory and motor stimulation testing. The cannula is maintained in place for 480 seconds with the radiofrequency generator switched off (sham PRF). Immediately following the sham phase, the identical 10 mL solution (8 mL dextrose 5%, 1 mL triamcinolone acetonide 40 mg, and 1 mL lidocaine 1%) is injected around the nerve (5 mL superficial and 5 mL deep). |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change from Baseline in Pain Severity on the Visual Analogue Scale (VAS) at 6 Months
Ramy czasowe: Baseline and 6 months post-intervention
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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. |
Baseline and 6 months post-intervention
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- PRF for Tarsal Tunnel Syndrome
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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