NCT07390279

Brief Summary

Postherpetic neuralgia (PHN) is a chronic pain syndrome that may be resistant to treatment and can lead to physical and social disability as well as psychological disturbances, persisting for years in some patients. Varicella zoster virus remains latent in the sensory neurons of individuals who have previously had chickenpox. Reactivation of the latent virus results in herpes zoster. Herpes zoster typically begins with dermatomal pain, followed within a few days by the development of characteristic dermatomal skin rashes. These cutaneous lesions usually resolve within 2-4 weeks; however, pain may persist even after the rash has healed. There is variability in the literature regarding the definition of PHN. The development of PHN is associated with increased central neuronal sensitization, reduced inhibitory neuronal function, inflammation and nerve injury in the peripheral nervous system, and abnormal neural transmission following nerve damage. PHN is the most common complication of herpes zoster and occurs in approximately 9-19% of affected patients. Its incidence increases with age, occurring in about 2% of patients under 50 years of age, approximately 20% of those over 50 years, and nearly 35% of patients over 80 years of age. Various treatment options are available for the management of PHN-related pain, including pharmacological and interventional approaches. Systemic agents include tricyclic antidepressants, calcium channel alpha-2-delta ligands, serotonin-norepinephrine reuptake inhibitors, and opioids, while topical treatments include lidocaine and capsaicin. Interventional treatment options for PHN include epidural and intrathecal injections, sympathetic nerve blocks, erector spinae plane block, subcutaneous injections, and spinal cord stimulation.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2026

Completed
Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

January 28, 2026

Last Update Submit

January 28, 2026

Conditions

Keywords

postherpetic neuralgia

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale

    This scale allows for the numerical determination of the subjective intensity of pain by asking patients to rate their pain severity on a 10 cm line from 0 (no pain) to 10 (the most severe pain I have ever felt).

    3 months

Secondary Outcomes (1)

  • Neuropathic Pain Questionnaire-4

    3 months

Interventions

The TCPRF procedure will be performed by the same algology specialist. Patients will be monitored according to standard protocols, including noninvasive blood pressure, pulse oximetry, and electrocardiography. The procedure will be conducted in the supine position. For TCPRF, 45 × 98 mm transcutaneous electrodes (Equip, FIAB SPA, Via P. Costoli, Italy) will be used. Electrodes will be placed over the most painful area along the affected dermatome. TCPRF will be delivered at 80 volts, 2 Hz, and 20 ms pulse width for a duration of 8 minutes. The procedure will be repeated three times at one-week intervals.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will be conducted at the Algology Department of Istanbul Cemil Taşcıoğlu City Hospital, following approval by the institutional ethics committee, and will include patients aged 18 years and older diagnosed with postherpetic neuralgia (PHN) who are scheduled to receive transcutaneous pulsed radiofrequency (TCPRF) treatment in three sessions. Within the scope of the study, the following data will be recorded: age, sex, body mass index (BMI), side of the procedure, history of herpes zoster vaccination (live or recombinant), family history of herpes zoster, immunosuppression status (e.g., HIV infection, malignancy, steroid use), duration of symptoms, dermatome treated with TCPRF, TCPRF-related complications and adverse effects, Visual Analog Scale (VAS) scores, neuropathic pain assessment using the Douleur Neuropathique 4 (DN4) questionnaire, and health-related quality of life assessed using the Short Form-12 (SF-12).

You may qualify if:

  • Age ≥ 18 years
  • Diagnosis of postherpetic neuralgia (PHN)
  • No invasive or noninvasive treatment related to PHN (e.g., capsaicin, lidocaine patches) within the past 3 months
  • Provision of written informed consent

You may not qualify if:

  • Patients with a cardiac pacemaker
  • Known allergy to transcutaneous electrode pads
  • Active skin infection at the pad application site
  • Presence of a metallic implant in the treatment area
  • Circulatory disorders or skin lesions at the treatment site
  • Inability to maintain appropriate positioning
  • Inability to communicate effectively
  • Presence of psychosis or progressive neurological deficits
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Prof. Dr. Cemil Taşcioğlu City Hospital

Istanbul, Istanbul, 34000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Neuralgia, PostherpeticChronic Pain

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pain specialist

Study Record Dates

First Submitted

January 28, 2026

First Posted

February 5, 2026

Study Start

February 1, 2026

Primary Completion

June 1, 2026

Study Completion

August 3, 2026

Last Updated

February 5, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations