Postherpetic NeuralgiaNCT06420778
The Treatment of Postherpetic Neuralgia in the Head and Face With Superficial Needling Combined With Electroacupuncture
A study testing electroacupuncture and Pregabalin in people with Postherpetic Neuralgia and Electroacupuncture, run by Zhejiang Chinese Medical University at 1 site in China.
Trial summary
Based on the inclusion and exclusion criteria, patients with head and face PHN who met the requirements were selected as trial subjects, and the efficacy was clarified in a randomized controlled design trial. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Postherpetic Neuralgia, Electroacupuncture, Infrared Thermography
- What is being tested?
- electroacupuncture and Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 12 Jul 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the diagnostic criteria in the 2016 Chinese Expert Consensus on the Diagnosis and Treatment of Postherpetic Neuralgia; Age 50-80 years (including telangiectasia), gender is not limited; Have a history of herpes zoster on the head and face, and the lesions on the head and face have been healed and subsided, and the symptoms of neuralgia lasted ≥1 month after lesions were healed, with baseline scores of ≥4 on the Facial Pain Profile, and abnormal sensation of the skin around the lesions, pain sensitivity; Be conscious and have a clear sense of pain and discriminative ability; Sign the informed consent to participate in this study voluntarily. Only those who satisfy the above 5 items at the same time can be included in this study.
Who cannot join
- those who did not meet the above diagnostic criteria; herpes zoster occurring in the perineum, or special types such as visceral herpes zoster, meningeal herpes zoster, and generalized herpes zoster; those who were taking oral pregabalin at a dose of less than 0.2 g or more than 0.6 g per day before inclusion to relieve analgesia; those who had a serious adverse reaction to pregabalin, were allergic to acupuncture, or belonged to patients who were within the range of contraindications to electro-acupuncture; Combined with severe cardiac, hepatic, renal damage, epilepsy, head injury, or cognitive dysfunction, aphasia, psychiatric disorders, and other major diseases, who are unable to cooperate with the treatment; Combined with poorly controlled hypertension and diabetes mellitus patients; Pregnant or breastfeeding patients;8.Patients who are currently participating in other studies, and who have been enrolled in other clinical trials within the last 3 months. Anyone who meets any of these criteria will be excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiaoyu Li
Hangzhou, Zhejiang, 310053
Xiaoyu Li, +8618758240921, 673426608@qq.com
About this study
Official title: A Randomized Controlled Study on the Treatment of Postherpetic Neuralgia in the Head and Face With Superficial Needling Combined With Electroacupuncture
Based on the inclusion and exclusion criteria, patients with head and face PHN who met the requirements were selected as trial subjects, and the efficacy was clarified in a randomized controlled design trial. The visual analog score VAS was used as the primary evaluation index, and the depression self-assessment scale score , Hamilton depression scale, Pittsburgh sleep quality index scale, and quality of life evaluation scale (SF-36) were used as the secondary evaluation indexes, and oral pregabalin was used as the control group, and the subjects in the pregabalin and the plexus superficial stabbing combined with electroacupuncture groups were observed respectively at the time of Before treatment, immediately after the first treatment, after 2 days of treatment, after 2 weeks of treatment, after 4 weeks of treatment, after 1 month of follow-up after the end of treatment and after 2 months of follow-up after the end of treatment.
Read the detailed description
On the one hand, it was clarified whether plexus needle shallow stabbing combined with electroacupuncture for the treatment of PHN in the head and face has clear and stable advantages in pain reduction, improvement of mood, sleep quality and quality of life, and formed the clinical standardization of plexus needle shallow stabbing combined with electroacupuncture for the treatment of postherpetic neuralgia in the head and face, which in turn lays the foundation for the further popularization of acupuncture for the treatment of postherpetic neuralgia in the head and face, and also provides a new, scientific and effective way of thinking about clinical analgesic therapies for postherpetic neuralgia.
On the other hand, this study will clarify the correlation between facial thermal radiation characteristics and clinical symptoms in patients with head and face PHN, and apply infrared thermography as an objective evaluation of the efficacy index of plexus needling and shallow stabbing combined with electroacupuncture in the treatment of head and face PHN, which will provide a new method for objectively verifying the clinical efficacy of PHN.
- Being tested
- electroacupuncture, Pregabalin
- Medical subject headings
- Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupunctureOther
The patient takes the supine position, the whole body relaxes, the facial skin is routinely sterilized. Local acupuncture points along the head and face herpes zoster lesion branches with 0.18 × 25 mm millimetre needle series of shallow stabbing method row stabbing method.Han's Acupoint Neurostimulator (model HANS-200) was selected, local acupoints were chosen as Xiaguan+Quanliao or Xiaguan+Jiache, and distal acupoints were chosen as Hegu+Waiguan connected with electroacupuncture, sparse and dense wave 2/100 Hz was selected, and the treatment time was 60 minutes, and the intensity of the current was all to the extent that the patient could tolerate it. The needles were left in place for 60 minutes each time, once every other day, and the treatment was performed 3 times a week for 4 weeks, for a total of 12 treatments.
PregabalinDrug
Subjects in this group will be treated with oral pregabalin capsules only, 150 mg twice daily for 4 weeks.Pregabalin was administered with Lerica (specification: 75 mg*8 capsules,manufactured by Pfizer Pharmaceuticals Ltd).
| Study group | Role | What they receive |
|---|---|---|
| therapy group | Experimental | Subjects in this group will be treated with Cluster needle shallow stabbing combined with electroacupuncture.The treatment time was 60 minutes each time, once every other day, and the treatment was carried out 3 times a week for 4 consecutive weeks, for a total of 12 treatments. Receives: Other: electroacupuncture |
| Control group | Experimental | Subjects in this group will be treated with oral pregabalin capsules only, 150 mg twice daily for 4 weeks.Pregabalin was administered with Lerica (specification: 75 mg*8 capsules,manufactured by Pfizer Pharmaceuticals Ltd). Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale/Score
This scale is performed by two trained raters to perform a Self-rating depression scale（SDS）, usually in the form of conversation and observation. After the examination, the two raters will score independently.Baseline values were taken from the pre-treatment assessment, mean values from weeks 1 and 2 of the treatment period were taken at mid-treatment (2 weeks), and mean values from weeks 3 and 4 of the treatment period were taken at the end of treatment (4 weeks). Daily mean values were taken for one month at one month follow-up and for two months at two months follow-up.
Measured: VAS will be performed at the baseline (pre-treatment), the 2 week after intervention,the 1 month after intervention,the 1 month follow-up and the 2 month follow-up to evaluate the severity of the disease and the treatment effect.
Secondary outcomes (4)
Self-rating depression scale
This scale is performed by two trained raters to perform a Self-rating depression scale（SDS）, usually in the form of conversation and observation. After the examination, the two raters will score independently.
Measured: SDS will be performed at the baseline (pre-treatment), the 2 week after intervention,the 1 month after intervention,the 1 month follow-up and the 2 month follow-up to evaluate the severity of the disease and the treatment effect.
Hamilton depression scale
This scale is performed by two trained raters to perform a Hamilton depression scale (HAMD), usually in the form of conversation and observation. After the examination, the two raters will score independently.
Measured: HAMD will be performed at the baseline (pre-treatment), the 2 week after intervention,the 1 month after intervention,the 1 month follow-up and the 2 month follow-up to evaluate the severity of the disease and the treatment effect.
Pittsburgh Sleep Quality Index Scale
This scale is performed by two trained raters to perform a Pittsburgh Sleep Quality Index Scale（PSQI）, usually in the form of conversation and observation. After the examination, the two raters will score independently.
Measured: PSQI will be performed at the baseline (pre-treatment), the 2 week after intervention,the 1 month after intervention,the 1 month follow-up and the 2 month follow-up to evaluate the severity of the disease and the treatment effect.
Quality of Life Rating Scale
This scale is performed by two trained raters to perform aQuality of Life Rating Scale（SF-36）, usually in the form of conversation and observation. After the examination, the two raters will score independently.
Measured: SF-36 will be performed at the baseline (pre-treatment), the 2 week after intervention,the 1 month after intervention,the 1 month follow-up and the 2 month follow-up to evaluate the severity of the disease and the treatment effect.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start12 Jul 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postherpetic NeuralgiaStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Chinese Medical University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Xiaoyu Li, Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420778
- Sponsor's protocol ID
- 2023ZR030
- Status last verified
- Jun 2024
- First submitted
- 14 May 2024
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qiu P, Sun H, Xia Y, Qu S, Fang J, Li X. The efficacy of electroacupuncture for postherpetic neuralgia arising from herpes zoster affecting the cephalo-facial area: study protocol for a double center randomized controlled trial. Front Med (Lausanne). 2025 Aug 28;12:1616035. doi: 10.3389/fmed.2025.1616035. eCollection 2025.
PubMed 40950954
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study on the Treatment of Postherpetic Neuralgia in the Head and Face With Superficial Needling Combined With Electroacupuncture
- ClinicalTrials.gov ID
- NCT06420778
- Acronym / sponsor ID
- 2023ZR030
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Zhejiang Chinese Medical UniversityOther government
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Based on the inclusion and exclusion criteria, patients with head and face PHN who met the requirements were selected as trial subjects, and the efficacy was clarified in a randomized controlled design trial. The visual analog score VAS was used as the primary evaluation index, and the depression self-assessment scale score , Hamilton depression scale, Pittsburgh sleep quality index scale, and quality of life evaluation scale (SF-36) were used as the secondary evaluation indexes, and oral pregabalin was used as the control group, and the subjects in the pregabalin and the plexus superficial stabbing combined with electroacupuncture groups were observed respectively at the time of Before treatment, immediately after the first treatment, after 2 days of treatment, after 2 weeks of treatment, after 4 weeks of treatment, after 1 month of follow-up after the end of treatment and after 2 months of follow-up after the end of treatment.
Detailed description
On the one hand, it was clarified whether plexus needle shallow stabbing combined with electroacupuncture for the treatment of PHN in the head and face has clear and stable advantages in pain reduction, improvement of mood, sleep quality and quality of life, and formed the clinical standardization of plexus needle shallow stabbing combined with electroacupuncture for the treatment of postherpetic neuralgia in the head and face, which in turn lays the foundation for the further popularization of acupuncture for the treatment of postherpetic neuralgia in the head and face, and also provides a new, scientific and effective way of thinking about clinical analgesic therapies for postherpetic neuralgia.
On the other hand, this study will clarify the correlation between facial thermal radiation characteristics and clinical symptoms in patients with head and face PHN, and apply infrared thermography as an objective evaluation of the efficacy index of plexus needling and shallow stabbing combined with electroacupuncture in the treatment of head and face PHN, which will provide a new method for objectively verifying the clinical efficacy of PHN.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| therapy group | Experimental | Other: electroacupunctureSubjects in this group will be treated with Cluster needle shallow stabbing combined with electroacupuncture.The treatment time was 60 minutes each time, once every other day, and the treatment was carried out 3 times a week for 4 consecutive weeks, for a total of 12 treatments. |
| Control group | Experimental | Drug: PregabalinSubjects in this group will be treated with oral pregabalin capsules only, 150 mg twice daily for 4 weeks.Pregabalin was administered with Lerica (specification: 75 mg*8 capsules,manufactured by Pfizer Pharmaceuticals Ltd). |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Meet the diagnostic criteria in the 2016 Chinese Expert Consensus on the Diagnosis and Treatment of Postherpetic Neuralgia; Age 50-80 years (including telangiectasia), gender is not limited; Have a history of herpes zoster on the head and face, and the lesions on the head and face have been healed and subsided, and the symptoms of neuralgia lasted ≥1 month after lesions were healed, with baseline scores of ≥4 on the Facial Pain Profile, and abnormal sensation of the skin around the lesions, pain sensitivity; Be conscious and have a clear sense of pain and discriminative ability; Sign the informed consent to participate in this study voluntarily. Only those who satisfy the above 5 items at the same time can be included in this study.
Key exclusion criteria (1 listed)
- those who did not meet the above diagnostic criteria; herpes zoster occurring in the perineum, or special types such as visceral herpes zoster, meningeal herpes zoster, and generalized herpes zoster; those who were taking oral pregabalin at a dose of less than 0.2 g or more than 0.6 g per day before inclusion to relieve analgesia; those who had a serious adverse reaction to pregabalin, were allergic to acupuncture, or belonged to patients who were within the range of contraindications to electro-acupuncture; Combined with severe cardiac, hepatic, renal damage, epilepsy, head injury, or cognitive dysfunction, aphasia, psychiatric disorders, and other major diseases, who are unable to cooperate with the treatment; Combined with poorly controlled hypertension and diabetes mellitus patients; Pregnant or breastfeeding patients;8.Patients who are currently participating in other studies, and who have been enrolled in other clinical trials within the last 3 months. Anyone who meets any of these criteria will be excluded.
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 |
|---|---|---|
| electroacupunctureThe patient takes the supine position, the whole body relaxes, the facial skin is routinely sterilized. Local acupuncture points along the head and face herpes zoster lesion branches with 0.18 × 25 mm millimetre needle series of shallow stabbing method row stabbing method.Han's Acupoint Neurostimulator (model HANS-200) was selected, local acupoints were chosen as Xiaguan+Quanliao or Xiaguan+Jiache, and distal acupoints were chosen as Hegu+Waiguan connected with electroacupuncture, sparse and dense wave 2/100 Hz was selected, and the treatment time was 60 minutes, and the intensity of the current was all to the extent that the patient could tolerate it. The needles were left in place for 60 minutes each time, once every other day, and the treatment was performed 3 times a week for 4 weeks, for a total of 12 treatments. | Other | therapy group |
| PregabalinSubjects in this group will be treated with oral pregabalin capsules only, 150 mg twice daily for 4 weeks.Pregabalin was administered with Lerica (specification: 75 mg*8 capsules,manufactured by Pfizer Pharmaceuticals Ltd). | Drug | Control group |
Primary outcome
Visual Analogue Scale/Score
Time frame: VAS will be performed at the baseline (pre-treatment), the 2 week after intervention,the 1 month after intervention,the 1 month follow-up and the 2 month follow-up to evaluate the severity of the disease and the treatment effect.
This scale is performed by two trained raters to perform a Self-rating depression scale（SDS）, usually in the form of conversation and observation. After the examination, the two raters will score independently.Baseline values were taken from the pre-treatment assessment, mean values from weeks 1 and 2 of the treatment period were taken at mid-treatment (2 weeks), and mean values from weeks 3 and 4 of the treatment period were taken at the end of treatment (4 weeks). Daily mean values were taken for one month at one month follow-up and for two months at two months follow-up.
4 secondary outcomes
Self-rating depression scale
Time frame: SDS will be performed at the baseline (pre-treatment), the 2 week after intervention,the 1 month after intervention,the 1 month follow-up and the 2 month follow-up to evaluate the severity of the disease and the treatment effect.
Hamilton depression scale
Time frame: HAMD will be performed at the baseline (pre-treatment), the 2 week after intervention,the 1 month after intervention,the 1 month follow-up and the 2 month follow-up to evaluate the severity of the disease and the treatment effect.
Pittsburgh Sleep Quality Index Scale
Time frame: PSQI will be performed at the baseline (pre-treatment), the 2 week after intervention,the 1 month after intervention,the 1 month follow-up and the 2 month follow-up to evaluate the severity of the disease and the treatment effect.
Quality of Life Rating Scale
Time frame: SF-36 will be performed at the baseline (pre-treatment), the 2 week after intervention,the 1 month after intervention,the 1 month follow-up and the 2 month follow-up to evaluate the severity of the disease and the treatment effect.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Derived from this study: PubMed 40950954Qiu P, Sun H, Xia Y, Qu S, Fang J, Li X. The efficacy of electroacupuncture for postherpetic neuralgia arising from herpes zoster affecting the cephalo-facial area: study protocol for a double center randomized controlled trial. Front Med (Lausanne). 2025 Aug 28;12:1616035. doi: 10.3389/fmed.2025.1616035. eCollection 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroacupuncture and Pregabalin in people with Postherpetic Neuralgia and Electroacupuncture, run by Zhejiang Chinese Medical University at 1 site in China.
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 1 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: status not confirmed, as of the sponsor's last update on 6 Apr 2025. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyu Li (+8618758240921, 673426608@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale/Score (time frame: VAS will be performed at the baseline (pre-treatment), the 2 week after intervention,the 1 month after intervention,the 1 month follow-up and the 2 month follow-up to evaluate the severity of the disease and the treatment effect.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06420778, which also lists 1 linked publication.
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 6 Apr 2025.