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

NCT ID: NCT05208918

Last Updated: 2022-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2022-09-15

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.

Conditions

Postherpetic Neuralgia; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Epidural steroid group

Transforaminal steroid application to the dorsal root ganglion of the affected dermatome of herpes zoster related pain in affected patients

Group Type: ACTIVE_COMPARATOR

Epidural steroid

Intervention Type: PROCEDURE

Injection of Depo-Medrol of affected dermatomes

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

Group Type: ACTIVE_COMPARATOR

PRF plus steroids injection

Intervention Type: PROCEDURE

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

Interventions

Epidural steroid

Injection of Depo-Medrol of affected dermatomes

Intervention Type: 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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: collaborator

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Mohammed Alseoudy

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mahmoud M Alseoudy, MD

Role: PRINCIPAL_INVESTIGATOR

mansoura university, faculty of medicine

khadega Elhossieny, MD

Role: STUDY_DIRECTOR

Zagazig University

Locations

Zagazig university hospital

Zagazig, Ash-sharqia, Egypt

Countries

Egypt

References

Jiang X, Li Y, Chen N, Zhou M, He L. Corticosteroids for preventing postherpetic neuralgia. Cochrane Database Syst Rev. 2023 Dec 5;12(12):CD005582. doi: 10.1002/14651858.CD005582.pub5.

Reference Type: DERIVED

PMID: 38050854 (View on PubMed)

Other Identifiers

ZU-IRB#9199

Identifier Type: -

Identifier Source: org_study_id