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

Sponsor
Mansoura University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05208918
Collaborator
Zagazig University (Other)
40
1
2
8.9
4.5

Study Details

Study Description

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 pulsed RF alone.

Condition or Disease Intervention/Treatment Phase
  • Procedure: PRF
  • Procedure: PRF plus steroids injection
N/A

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 pulsed RF alone.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Combined Application of Pulsed Radiofrequency and a Steroid to the Dorsal Root Ganglion for Postherpetic Neuralgia: a Randomized Controlled Trial
Actual Study Start Date :
Oct 22, 2021
Anticipated Primary Completion Date :
Jun 15, 2022
Anticipated Study Completion Date :
Jul 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: PRF group

Pulsed radiofrequency application to the dorsal root ganglion of the affected dermatome of herpes zoster related pain in affected patients

Procedure: PRF
Pulsed radiofrequency with temperature 42 degrees for 6 minutes to be applied to the dorsal root ganglion of affected dermatomes

Active Comparator: PRF plus steroids group

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
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

Outcome Measures

Primary Outcome Measures

  1. Numerical rating scale [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zagazig university hospital Zagazig Ash-sharqia Egypt 44511

Sponsors and Collaborators

  • Mansoura University
  • Zagazig University

Investigators

  • Principal Investigator: Mahmoud M Alseoudy, MD, mansoura university, faculty of medicine
  • Study Director: khadega Elhossieny, MD, Zagazig University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mahmoud Mohammed Alseoudy, Lecturer of anesthesia, ICU & pain management; Faculty of Medicine, Mansoura University
ClinicalTrials.gov Identifier:
NCT05208918
Other Study ID Numbers:
  • ZU-IRB#9199
First Posted:
Jan 26, 2022
Last Update Posted:
Jan 26, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 26, 2022