NCT05208918

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
Last Updated

October 18, 2022

Status Verified

October 1, 2022

Enrollment Period

7 months

First QC Date

January 12, 2022

Last Update Submit

October 15, 2022

Conditions

Postherpetic NeuralgiaChronic Pain

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Epidural steroid group

ACTIVE COMPARATOR

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

Procedure: Epidural steroid

PRF plus steroids group

ACTIVE COMPARATOR

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

Interventions

Epidural steroidPROCEDURE

Injection of Depo-Medrol of affected dermatomes

Epidural steroid group
PRF plus steroids injectionPROCEDURE

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

PRF plus steroids group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with ASA I\&II status
  • Thoracic zoster related pain
  • less than three months duration from the appearance of shingles

You may not qualify if:

  • coagulopathy
  • local infection
  • patient refusal
  • Diabetes Melliteus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig university hospital

Zagazig, Ash-sharqia, 44511, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 38050854DERIVED

MeSH Terms

Conditions

Neuralgia, PostherpeticChronic Pain

Interventions

Prolactin-Releasing HormoneSteroids

Condition Hierarchy (Ancestors)

NeuralgiaPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteinsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Mahmoud M Alseoudy, MD

    mansoura university, faculty of medicine

    PRINCIPAL INVESTIGATOR

  • khadega Elhossieny, MD

    Zagazig University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia, ICU & pain management; Faculty of Medicine

Study Record Dates

First Submitted

January 12, 2022

First Posted

January 26, 2022

Study Start

February 1, 2022

Primary Completion

September 5, 2022

Study Completion

September 15, 2022

Last Updated

October 18, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)