Combined Application of Pulsed RF and Steroids to the DRG for PHN

Study Overview
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Brief Summary
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Recently, the use of pulsed radiofrequency has increased in many chronic pain conditions, including trigeminal neuralgia, chronic spinal pain, musculoskeletal pain, and it was recently used effectively for postherpetic neuralgia. Transforaminal epidural steroid injection has been proven in previous studies to provide effective analgesia for cases of herpes zoster-related pain. We hypothesize that the combined use of pulsed RF and steroid injection applied to the DRG may achieve better outcomes than the use of epidural steroid injection alone.

Detailed Description
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Varicella-zoster virus reactivates in sensory ganglia as the dorsal root ganglion (DRG). The DRG contains many receptor channels and is an important region for pain signal transduction. Sustained abnormal electrical activity to the spinal cord via the DRG in acute herpes zoster can result in neuropathic conditions such as postherpetic neuralgia (PHN). Postherpetic neuralgia (PHN) is the final stage of varicella-zoster infection and is manifested as severe refractory neuropathic pain. Preventing the transition of herpes zoster-related pain to PHN is a very important therapeutic principle for patients at an early stage, especially for older patients. The exact discriminative time point for PHN has not yet been standardized. Various criteria have been used, from 30 days to 180 days after zoster onset. If pain persists for more than 180 days after zoster onset, the likelihood of pain reduction is very low and such a condition is considered well established PHN. Therefore, it is advisable to actively attempt various treatment modalities for pain control before the condition progresses to a recalcitrant state. Pulsed radiofrequency (PRF) is a variant of thermal radiofrequency that applies pulsed current to limit heat generation to less than 42˚C, creating a little risk of thermal or nerve injury. Recently, the use of PRF has increased in many chronic pain conditions, including trigeminal neuralgia, chronic spinal pain, musculoskeletal pain, and it was recently used effectively for postherpetic neuralgia. Transforaminal epidural steroid injection has been proven in previous studies to provide effective analgesia for cases of herpes zoster-related pain. We hypothesize that combined use of pulsed RF and steroid injection applied to the DRG may achieve a better outcome than use of epidural steroid injection alone.

Official Title
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Effectiveness and Durability of Combined Application of Pulsed Radiofrequency and a Steroid to the Dorsal Root Ganglion for Postherpetic Neuralgia: a Randomized Controlled Trial

Conditions
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Postherpetic Neuralgia, Chronic Pain

Intervention / Treatment
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* Procedure: Epidural steroid
* Procedure: PRF plus steroids injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with ASA I&II status Thoracic zoster related pain less than three months duration from the appearance of shingles Exclusion Criteria: coagulopathy local infection patient refusal Diabetes Melliteus

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epidural steroid group<br>Transforaminal steroid application to the dorsal root ganglion of the affected dermatome of herpes zoster related pain in affected patients | Procedure: Epidural steroid<br>* Injection of Depo-Medrol of affected dermatomes<br>|
| Active Comparator: PRF plus steroids group<br>Pulsed radiofrequency plus Depo-Medrol (steroid) application to the dorsal root ganglion of the affected dermatome of herpes zoster related pain in affected patients | Procedure: PRF plus steroids injection<br>* Pulsed radiofrequency with temperature 42 degrees for 6 minutes to be applied to the dorsal root ganglion plus injection of Depo-Medrol of affected dermatomes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical rating scale | Numerical rating scale (the 11-point numeric scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine or worst pain imaginable) to be recorded before intervention and at one week, 1 month , 2 months, and 3 months and 6 months after intervention. | Up to 6 months after the intervention |