Efficacy of Transcutaneous Pulsed Radiofrequency in Postherpetic Neuralgia

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorProf. Dr. Cemil Tascıoglu Education and Research Hospital Organization

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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).

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Transcutaneous Pulsed Radiofrequency

    Procedure/Surgery

    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.

Treatment groups

No treatment groups listed

Trial outcomes

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).

Time frame
3 months

Secondary outcomes

1

Neuropathic Pain Questionnaire-4

This is a Turkish-validated diagnostic screening test consisting of 10 items in total: 7 symptoms based on patient description and 3 clinical findings based on physical examination, which helps differentiate neuropathic pain from nociceptive pain.

Time frame
3 months

Other outcomes

Sponsors and contacts

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