The purpose of this study is to evaluate the therapeutic efficacy of transcutaneous auricular vagus nerve stimulation (taVNS) in the treatment of patients with post-herpetic neuralgia (PHN). Participants will receive taVNS in addition to standard care. The study aims to determine whether taVNS can provide significant pain relief and improve quality of life in PHN patients.
Post-herpetic neuralgia (PHN) is a chronic neuropathic pain condition that persists for months or years following the resolution of herpes zoster (HZ) infection. It is characterized by persistent burning, stabbing, or shooting pain, often accompanied by allodynia and hyperalgesia, which can significantly impair quality of life. Current treatment options for PHN, including pharmacological therapies, often provide incomplete pain relief and are associated with side effects, creating a need for novel, non-invasive interventions. This randomized controlled trial aims to evaluate the therapeutic efficacy of transcutaneous auricular vagus nerve stimulation (taVNS) as an adjunct to standard medical treatment for patients with PHN. The vagus nerve plays a crucial role in modulating pain perception and inflammatory processes, and its non-invasive stimulation through the auricular branch has shown promising analgesic effects in various chronic pain syndromes. A total of 34 male and female participants, aged 35-65 years, diagnosed with PHN will be randomly allocated into two equal groups (17 participants per group). Group A (Experimental) will receive taVNS in addition to conventional pharmacological management, while Group B (Control) will receive conventional pharmacological management alone. The taVNS intervention will be delivered using the EV-906 device with TENS ear clips, applied according to the study protocol and safety standards (ISO 13485, FDA QSR, and CE compliance). Pain intensity and quality will be assessed at baseline, after two weeks, and after four weeks using validated outcome measures: the Brief Pain Inventory (BPI) short form and the Short-form McGill Pain Questionnaire-2 (SF-MPQ-2). The primary outcome is the change in pain severity scores, and the secondary outcome is the change in pain interference with daily activities. The results of this study will provide evidence regarding the clinical utility of taVNS as a safe, non-invasive, and effective adjunct therapy for PHN, with the potential to improve patient outcomes and quality of life
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Use of the EV-906 device with TENS ear clips for transcutaneous auricular vagus nerve stimulation (taVNS), applied according to the study protocol, in addition to standard medical treatment for post-herpetic neuralgia. This device meets ISO 13485, FDA QSR, and CE standards
Standard medical treatment for post-herpetic neuralgia as per current clinical guidelines, without the application of taVNS device.
Faculty of Physical Therapy - Cairo University
Cairo, Giza Governorate, Egypt
RECRUITINGBrief Pain Inventory - Short Form (BPI-SF)
the Brief Pain Inventory-Short Form (BPI SF) is a valuable tool for assessing pain severity and its impact on daily functioning on a 0-10 numeric rating scale, with higher scores indicating more severe pain.
Time frame: Administered three times: before the first treatment session, after 2 weeks, and after 4 weeks. Administration mode: Interview-based.
Short form McGill pain questionnaire 2 (SF-MPQ-2)
The SF-MPQ-2 is a validated tool assessing sensory, affective, and evaluative qualities of pain. Participants rate the intensity of their pain using a 0-10 scale: 0: No pain 10: Worst pain imaginable Participants select the rating that best reflects their experience during the past week.
Time frame: Administered three times: before the first treatment session, after 2 weeks, and after 4 weeks. Administration mode: Interview-based.
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