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Clinical Trials/NCT05208918
NCT05208918
Completed
Not Applicable

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

Mansoura University1 site in 1 country40 target enrollmentFebruary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postherpetic Neuralgia
Sponsor
Mansoura University
Enrollment
40
Locations
1
Primary Endpoint
Numerical rating scale
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2022
End Date
September 15, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mahmoud Mohammed Alseoudy

Lecturer of anesthesia, ICU & pain management; Faculty of Medicine

Mansoura University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Numerical rating scale

Time Frame: Up to 6 months after the intervention

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.

Study Sites (1)

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