Dorsal Root Ganglion Stimulation in Postherpetic Neuropathy

NCT06225960 | Completed

• 1 other identifier: 2360CE
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, multicenter observational study evaluating the efficacy of ganglion stimulation (medical device) in cases of post-herpetic neuropathy. This study introduces recent methods of phenotypic stratification of postherpetic neuropathy into the field of interventional pain therapy. The aim is to identify which clinical expression of this diverse pathology can derive the greatest benefits from an otherwise effective but expensive therapy such as ganglion stimulation. The study protocol includes the application of a common clinical practice, already in use for several years at the promoting center and participating centers (as well as internationally scientifically codified). It is supported by an innovative stratification of clinical expression (phenotype of the disease), recently introduced in the literature. The study aims to identify, through careful clinical evaluation, predictive indices of the greatest success in invasive ganglion stimulation therapy, a treatment associated with significant system costs and considerable inconvenience for the patient. The results of the experimentation will allow the codification of evaluative clinical pathways to predict a higher success index in certain clinical expressions of postherpetic neuropathy compared to others. This will help reduce the costs of implant trials and enable defining the real objective of the proposed therapy in consultation with the patient.

Conditions

Postherpetic Neuralgia

Keywords

Postherpetic neuralgia, Dorsal root ganglion stimulation,

Outcome Measures

Primary Outcomes (1)

• Analgesic efficacy identifying the pathogenetic cluster with the greatest therapeutic response

  Average minimum and maximum pain with the NRS scale (0-10) DN4 (neuropathic pain) in the validated Italian version; SF12 (short form health questionnaire) in the validated Italian version• EQ5 (Euro QOL 5) in the validated Italian version.

  at 6 months

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with postherpetic neuralgia (PHN) for at least 6 months who have tried the topical and systemic pharmacological therapies recommended in the neuropathic pain guidelines

You may qualify if:

• Subjects of both genders aged between 18 and 75 years;
• Patients with postherpetic neuralgia (PHN) for at least 6 months who have tried the topical and systemic pharmacological therapies recommended in the neuropathic pain guidelines
• Distribution of neuropathic pain in a region between C6 and L5;
• Individuals capable of adequately adhering to the study protocol and responding to the administered questionnaires;
• Signed informed consent.

You may not qualify if:

• Subjects with a history of major depression or other psychiatric conditions that, in the investigator's opinion, may interfere with study participation;
• Patients in presumed/confirmed pregnancy;
• Patients for whom the placement of spinal/ganglion stimulation systems is contraindicated due to systemic pathological conditions.

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead
• Monaldi Hospital: collaborator
• Nuovo Regina Margherita Hospital: collaborator
• Azienda Ospedaliero-Universitaria di Parma: collaborator

Study Sites (1)

ICSMaugeri Spa

Pavia, 27100, Italy

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 26, 2024
• Study Start: August 8, 2022
• Primary Completion: February 19, 2023
• Study Completion: October 15, 2025
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

IT (1)