Post Herpetic Neuralgia (PHN)NCT07123987
Transcutaneous Auricular Vagus Nerve Stimulation on Post-Herpetic Neuralgia
A study testing transcutaneous auricular vagus nerve stimulation (taVNS) and traditional medical treatment for PHN in people with Post Herpetic Neuralgia (PHN), run by Mohamed Hosny Ismail Easa at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Post Herpetic Neuralgia (PHN)
- What is being tested?
- transcutaneous auricular vagus nerve stimulation (taVNS) and traditional medical treatment for PHN
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Sep 2025to 9 Sep 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 35-65 years diagnosed with PHN. Persistent pain for at least 3 months after herpes zoster infection. Only patients who sign the informed consent form will be included.
Who cannot join
- Contraindications to taVNS such as:
- pregnancy;
- active implants (e.g., pacemakers, cochlear implants) or brain shunts;
- previous neurological or psychiatric diagnoses;
- history of addiction or substance abuse;
- history of trauma and/or brain surgery;
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- cardiac disease;
- acute or chronic use of medications and/or illicit drugs;
- susceptibility to headaches and seizures. Severe cognitive impairment. Other chronic pain conditions.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Physical Therapy - Cairo University
Cairo, Giza Governorate, 12613
About this study
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.
Read the detailed description
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
- Conditions
- Post Herpetic Neuralgia (PHN)
- Being tested
- transcutaneous auricular vagus nerve stimulation (taVNS), traditional medical treatment for PHN
- Keywords
- Post-Herpetic Neuralgia, Neuropathic Pain, Herpes Zoster, Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), Non-invasive Neuromodulation, Chronic Pain Management, Pain Relief, Randomized Controlled Trial
- Medical subject headings
- Neuralgia, Postherpetic, Neuralgia, Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous auricular vagus nerve stimulation (taVNS)Device
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
traditional medical treatment for PHNOther
Standard medical treatment for post-herpetic neuralgia as per current clinical guidelines, without the application of taVNS device.
| Study group | Role | What they receive |
|---|---|---|
| Group (A): Study group | Experimental | this group will receive taVNS in addition to traditional medical treatment Receives: Device: transcutaneous auricular vagus nerve stimulation (taVNS) |
| Group (B): Control group | Active comparator | this group will receive the same traditional medical treatment only Receives: Other: traditional medical treatment for PHN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory-Short Form (BPI-SF) Total Score
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.
Measured: Baseline, 2 weeks, and 4 weeks
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.
Measured: Administered three times: before the first treatment session, after 2 weeks, and after 4 weeks. Administration mode: Interview-based.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start7 Sep 2025
- Primary completion9 Sep 2026
- Study completion9 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post Herpetic Neuralgia (PHN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Thirty-four male and female patients diagnosed with PHN, aged between 35 and 65 years, will be randomly allocated into two equal groups, each containing 17 patients: Group (A): Study group - This group will receive taVNS in addition to traditional medical treatment. Group (B): Control group - This group will receive the same traditional medical treatment only.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohamed Hosny Ismail Easa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Hosny Ismail Easa, Cairo University
- Investigators
- Wafaa Hussein Borhan, PhD, Study chair, Professor of Physical Therapy for Surgery Department, Faculty of Physical Therapy, Cairo UniversityRofaida El Sayed El Naggar, MD, Study director, Lecturer of Dermatology, Kasr Alainy, Faculty of Medicine, Cairo UniversityDoaa Atef Aly, PhD, Study director, Lecturer of Physical Therapy for Surgery Department, Faculty of Physical Therapy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07123987
- Sponsor's protocol ID
- P.T.REC/012/005412
- Status last verified
- Oct 2026
- First submitted
- 12 Aug 2025
- Last updated
- 29 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared due to participant confidentiality and restrictions imposed by the institutional ethics committee
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Auricular Vagus Nerve Stimulation on Post-Herpetic Neuralgia
- ClinicalTrials.gov ID
- NCT07123987
- Acronym / sponsor ID
- P.T.REC/012/005412
- Conditions
- Post Herpetic Neuralgia (PHN)
- Keywords
- Post-Herpetic Neuralgia, Neuropathic Pain, Herpes Zoster, Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), Non-invasive Neuromodulation, Chronic Pain Management, Pain Relief, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Mohamed Hosny Ismail EasaUniversity, hospital or other
- Study start
- 7 Sep 2025 (actual)
- Primary completion
- 9 Sep 2026 (actual)
- Study completion
- 9 Sep 2026 (actual)
- First posted
- 15 Aug 2025 (actual)
- Results
- Posted 29 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Thirty-four male and female patients diagnosed with PHN, aged between 35 and 65 years, will be randomly allocated into two equal groups, each containing 17 patients: Group (A): Study group - This group will receive taVNS in addition to traditional medical treatment. Group (B): Control group - This group will receive the same traditional medical treatment only.
| Arm | Type | Receives |
|---|---|---|
| Group (A): Study group | Experimental | Device: transcutaneous auricular vagus nerve stimulation (taVNS)this group will receive taVNS in addition to traditional medical treatment |
| Group (B): Control group | Active comparator | Other: traditional medical treatment for PHNthis group will receive the same traditional medical treatment only |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 35-65 years diagnosed with PHN. Persistent pain for at least 3 months after herpes zoster infection. Only patients who sign the informed consent form will be included.
Key exclusion criteria (9 listed)
- pregnancy;
- active implants (e.g., pacemakers, cochlear implants) or brain shunts;
- previous neurological or psychiatric diagnoses;
- history of addiction or substance abuse;
- history of trauma and/or brain surgery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcutaneous auricular vagus nerve stimulation (taVNS)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 | Device | Group (A): Study group |
| traditional medical treatment for PHNStandard medical treatment for post-herpetic neuralgia as per current clinical guidelines, without the application of taVNS device. | Other | Group (B): Control group |
Primary outcome
Brief Pain Inventory-Short Form (BPI-SF) Total Score
Time frame: Baseline, 2 weeks, and 4 weeks
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.
Short Form McGill Pain Questionnaire 2 (SF-MPQ-2)
Time frame: Administered three times: before the first treatment session, after 2 weeks, and after 4 weeks. Administration mode: Interview-based.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data will not be shared due to participant confidentiality and restrictions imposed by the institutional ethics committee
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wafaa Hussein Borhan, PhD study chair
Professor of Physical Therapy for Surgery Department, Faculty of Physical Therapy, Cairo University
Rofaida El Sayed El Naggar, MD study director
Lecturer of Dermatology, Kasr Alainy, Faculty of Medicine, Cairo University
Doaa Atef Aly, PhD study director
Lecturer of Physical Therapy for Surgery Department, Faculty of Physical Therapy, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous auricular vagus nerve stimulation (taVNS) and traditional medical treatment for PHN in people with Post Herpetic Neuralgia (PHN), run by Mohamed Hosny Ismail Easa at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory-Short Form (BPI-SF) Total Score (time frame: Baseline, 2 weeks, and 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.