Combined Application of Pulsed RF and Steroids to the DRG for PHN
Primary Purpose
Postherpetic Neuralgia, Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Epidural steroid
PRF plus steroids injection
Sponsored by
About this trial
This is an interventional treatment trial for Postherpetic Neuralgia
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
Sites / Locations
- Zagazig university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Epidural steroid group
PRF plus steroids group
Arm Description
Transforaminal steroid application to the dorsal root ganglion of the affected dermatome of herpes zoster related pain in affected patients
Pulsed radiofrequency plus Depo-Medrol (steroid) application to the dorsal root ganglion of the affected dermatome of herpes zoster related pain in affected patients
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05208918
First Posted
January 12, 2022
Last Updated
October 15, 2022
Sponsor
Mansoura University
Collaborators
Zagazig University
1. Study Identification
Unique Protocol Identification Number
NCT05208918
Brief Title
Combined Application of Pulsed RF and Steroids to the DRG for PHN
Official Title
Effectiveness and Durability of Combined Application of Pulsed Radiofrequency and a Steroid to the Dorsal Root Ganglion for Postherpetic Neuralgia: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
September 5, 2022 (Actual)
Study Completion Date
September 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
Collaborators
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postherpetic Neuralgia, Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Epidural steroid group
Arm Type
Active Comparator
Arm Description
Transforaminal steroid application to the dorsal root ganglion of the affected dermatome of herpes zoster related pain in affected patients
Arm Title
PRF plus steroids group
Arm Type
Active Comparator
Arm Description
Pulsed radiofrequency plus Depo-Medrol (steroid) application to the dorsal root ganglion of the affected dermatome of herpes zoster related pain in affected patients
Intervention Type
Procedure
Intervention Name(s)
Epidural steroid
Intervention Description
Injection of Depo-Medrol of affected dermatomes
Intervention Type
Procedure
Intervention Name(s)
PRF plus steroids injection
Intervention Description
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
Primary Outcome Measure Information:
Title
Numerical rating scale
Description
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.
Time Frame
Up to 6 months after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud M Alseoudy, MD
Organizational Affiliation
mansoura university, faculty of medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
khadega Elhossieny, MD
Organizational Affiliation
Zagazig University
Official's Role
Study Director
Facility Information:
Facility Name
Zagazig university hospital
City
Zagazig
State/Province
Ash-sharqia
ZIP/Postal Code
44511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Combined Application of Pulsed RF and Steroids to the DRG for PHN
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