Postherpetic NeuralgiaNCT06290661
Clinical Trial of the Safety and Efficacy of Peripheral Nerve Stimulation in the Treatment of Peripheral Neuropathic Pain.
A study testing Active electrostimulation in people with Postherpetic Neuralgia and Peripheral Neuropathic Pain, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate safety and efficacy of percutaneous peripheral nerve stimulation in patients with peripheral neuropathic pain. The main questions it aims to answer are: 1. The efficacy of percutaneous peripheral nerve stimulation in patients with peripheral neuropathic pain 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postherpetic Neuralgia, Peripheral Neuropathic Pain, Trigeminal Neuralgia
- What is being tested?
- Active electrostimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 9 Feb 2023to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old and above, male or female
- Diagnosed by trained clinical doctors as postherpetic neuralgia, which is an indication for peripheral nerve stimulation therapy;
- Assess the damage or disease of the peripheral sensory system through the four questions of Douleur Neuropathy before surgery;
- The subject has received conventional treatment but the efficacy is poor, or cannot tolerate the side effects of conventional treatment;
- Visual analogue scale for pain within 24 hours before surgery ≥ 5;
- The subjects are able to understand the purpose of this study, have sufficient compliance with the research treatment, and are willing to sign an informed consent form;
Who cannot join
- Subjects who need to receive both radio frequency modulation and intrathecal drug infusion treatment simultaneously;
- Subjects who are known to have cardiac implants (pacemakers or defibrillators) or other implantable neural stimulators (spinal cord stimulators or deep brain stimulators, etc.);
- Subjects with severe psychological and/or mental disorders and/or non therapeutic drug dependence;
- Subjects expected to undergo MRI examination within 30 days after PNS implantation;
- Expected to be discharged within 48 hours or less;
- Target nerve damage or muscle defects in known pain areas;
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- Subjects who are known to be allergic to skin contact materials (tape or adhesive);
- Allergy to anesthetics such as lidocaine;
- Concomitant severe heart disease, liver disease, kidney disease, respiratory system disease, and coagulation dysfunction;
- Pregnant women, lactating women, or women planning to have children within the next three months;
- Subjects who have participated in any other clinical trial, or who may participate in any other trial after enrollment;
- Other situations that the researcher deems unsuitable for participation in this clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Union Hospital, Tongji medical college, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Dong Yang, PHD, 13871230491 ext. 86, dongyang118@sina.com
About this study
Official title: Prospective, Multicentre, Randomised Withdrawal Design of a Clinical Trial Evaluating the Safety and Efficacy of a Percutaneous Peripheral Nerve Stimulation System for Patients With Peripheral Neuropathic Pain.
The goal of this clinical trial is to evaluate safety and efficacy of percutaneous peripheral nerve stimulation in patients with peripheral neuropathic pain. The main questions it aims to answer are:
- The efficacy of percutaneous peripheral nerve stimulation in patients with peripheral neuropathic pain
- The safety of percutaneous peripheral nerve stimulation in patients with peripheral neuropathic pain Participants are going to undergo procedure that implant peripheral nerve stimulation electrode produced by Jiangsu CED Medtech Co., Ltd. Then the subjects, whose VAS scores decrease more 30% than baseline level, are classified into two groups randomly. One of the group receiving active stimulation called trial group and another receiving placebo stimulation called control group. All subjects are required to make their own subjects' pain diary to record VSA score before and after implantation until at the end of follow-up. Also, participants are asked to report use of analgesic medications, number of awakenings and adverse events.
Researchers will compare pain scores between the two groups to see if peripheral nerve stimulation is effective to patients with peripheral neuropathic pain.
Read the detailed description
The investigators divide study process into 3 main periods called enrollment/baseline period, treatment period and follow-up period. The treatment period is classified into test period, randomized withdrawal period and observation period further.
- Enrollment/baseline period This study will be conducted at four clinical trial sites in China with 3 to 6 subjects included in the pretest and the formal trial planned to enroll 56 subjects. All subjects enter screening process after signing the informed consent form (ICF) approved by the ethics committee. Subjects are enrolled who meet inclusion criteria and do not meet any exclusion criteria. Enrolled subjects will undergo vital signs, physical examination, laboratory tests, and visual analogue scale (VAS) scores for pain for at least 4 days, Neuropathic Pain Scale (DN4), and the Short Form Health Survey (SF-36) as part of the screening period assessment prior to electrode implantation.
- Treatment period 2.1 Implantation of devices Enrolled subjects are implanted with the percutaneous peripheral nerve stimulation system, which was parameterized by the investigator via a programmable controller. Subjects are provided with a "Transcutaneous Peripheral Nerve Stimulation Remote Control Instruction Manual" to guide them in the proper operation and use of the system. 2.2 Test period Investigators will adjust stimulation parameters and record VAS score under different parameters conditions. The enrolled subjects are provided 1 to 5 stimulation therapy patterns parameterized by investigators after the test. Then the subjects receive continuous stimulation with parameterized patterns of 7 (±3) days and VAS scores are be recorded every day of 7 days. Subjects will enter next stage if their VAS scores decrease more than 30% from baseline level or withdraw the trial as reduction less than 30% and devices are removed. 2.3 Randomized withdrawal period Subject will be classified into random group. One of the group receiving active stimulation called trial group and another receiving placebo stimulation called control group. Both of two groups are performed stimulation in the next 7 days. The subjects of control group will get active stimulation again as the VAS scores back to and maintain 2 days at baseline level. VAS scores will be recorded every day during this period. 2.4 Observation period The devices are on work until 28th day after the implantation in trial group; stimulators are turned on after randomized withdrawal period until 28th day after the implantation in control group. All subjects have electrode leads removed on day 28 of implantation or at early withdrawal.
- Follow-up period Investigators will begin follow up as the removal of electrode leads or on the day 28 of implantation. Indicators including VAS score will be evaluated and recorded to assess the efficacy and safety of percutaneous peripheral nerve stimulation during follow-up.
- Being tested
- Active electrostimulation, Placebo electrostimulation
- Keywords
- Peripheral Nerve Stimulation, peripheral neuropathic pain
- Medical subject headings
- Neuralgia, Postherpetic, Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active electrostimulationDevice
Maintain the electrical stimulation state, and according to the patient's feeling to set the appropriate stimulation parameter range (pain relief and no obvious numbness and discomfort), the programme will be written into the patient's self-control remote control, by the patient according to their own pain situation for the independent control of the stimulation current.
Placebo electrostimulationDevice
No actual electrostimulation
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving active electrostimulation after implantation procedure | Experimental | Twenty-eight participants (anticipated) from different 4 hospital in China whose mean VAS scores decreased more than 30% compared with baseline scores after electrode implantation. They will still receive electrostimulation therapy during randomized withdrawal period. Receives: Device: Active electrostimulation |
| Participants receiving placebo electrostimulation after implantation procedure | Placebo comparator | Twenty-eight participants (anticipated) from different 4 hospital in China whose mean VAS scores decreased more than 30% compared with baseline scores after electrode implantation. The electrostimulation of them will be turned off during randomized withdrawal period. Receives: Device: Placebo electrostimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in mean pain visual analogue scale VAS scores between trial and control groups in the randomised withdrawal period
Researchers will collect visual analogue scale scores of 7 days after the implantation of peripheral nerve stimulation electrode to calculate mean scores of 4 days before randomized withdrawal and evaluate the difference in pain improvement of peripheral nerve stimulation between the two groups (trial and control group) by analyzing the mean change in VAS scores during randomized withdrawal period.
Measured: every day from 7 to 14 days after electrode implantation (randomized withdrawal period)
Visual simulation assessment scale collects pain scores after peripheral electrode placement
Researchers collected daily pain scores from the day of peripheral nerve stimulation electrode implantation until removal using the VAS pain scale, as well as pain scores on the 14th day after electrode removal.
Measured: Every day from 7 to 28 days after electrode implantation, as well as the 14th day after electrode removal
Secondary outcomes (7)
Proportion of subjects whose pain relief more than 30%
The VAS scores recorded in pain diary by participants during randomized withdrawal period decreased more 30% than baseline period.
Measured: Every day for 7 days after electrode implantation (test period)
Proportion of subjects of ideal pain state
The VAS scores recorded in pain diary by participants during test period, randomized withdrawal period and observation period less than forty millimeters.
Measured: Every day for 7 days after electrode implantation (test period), every day from 7 to 14 days after electrode implantation (randomized withdrawal period), and every day from 14 to 28 days after electrode implantation (observation period)
Sleep-related assessment after electrostimulation
The number of awakenings in sleep diary by participants during test period, randomized withdrawal period and observation period.
Measured: Every day for 7 days after electrode implantation (test period), every day from 7 to 14 days after electrode implantation (randomized withdrawal period), and every day from 14 to 28 days after electrode implantation (observation period)
Change of life quality after electrostimulation
The subjects will be asked to fulfill the Mos 36-item Short Form Health Survey with assistance of clinical physician.
Measured: 4 days before electrode implantation, 7, 14, 21, 28 days after electrode implantation, and 14 days after electrode removal.
Analgesic medications
Participants themselves record the analgesic medications of name, dosage, numbers, routine and duration after peripheral nerve stimulation.
Measured: Every day from 4 days before electrode implantation to 14 days after electrode removal.
Stability of external assistant devices
The stability is assessed with failure rate which defined as number of failures divided by total number of uses.
Measured: Every day from the 1st to 28th day after electrode implantation, as well as the 14th day after electrode removal.
Questionnaire survey equipment satisfaction
A questionnaire survey (0-10 points, 0 points very dissatisfied, 10 points very satisfied) was conducted for each surgeon on the ease of operation of the product and the reasons for dissatisfaction were recorded; a questionnaire survey (0-10 points, 0 points very dissatisfied, 10 points very satisfied) was conducted for each subject on the comfort and ease of use of the equipment and the reasons for dissatisfaction were recorded.
Measured: On the first day of electrode implantation and the day of electrode removal (remove the electrode 28 days after surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start9 Feb 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postherpetic NeuralgiaStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, The Second People's Hospital of GuangDong Province, Xiamen Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290661
- Sponsor's protocol ID
- UHCT-IEC-SOP-016-03-01
- Status last verified
- Jul 2025
- First submitted
- 1 Feb 2024
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mobbs RJ, Nair S, Blum P. Peripheral nerve stimulation for the treatment of chronic pain. J Clin Neurosci. 2007 Mar;14(3):216-21; discussion 222-3. doi: 10.1016/j.jocn.2005.11.007.
PubMed 17258129Al-Jehani H, Jacques L. Peripheral nerve stimulation for chronic neurogenic pain. Prog Neurol Surg. 2011;24:27-40. doi: 10.1159/000323017. Epub 2011 Mar 21.
PubMed 21422774Weiner RL, Reed KL. Peripheral neurostimulation for control of intractable occipital neuralgia. Neuromodulation. 1999 Jul;2(3):217-21. doi: 10.1046/j.1525-1403.1999.00217.x.
PubMed 22151211Slavin KV. Peripheral nerve stimulation for neuropathic pain. Neurotherapeutics. 2008 Jan;5(1):100-6. doi: 10.1016/j.nurt.2007.11.005.
PubMed 18164488Gilmore C, Ilfeld B, Rosenow J, Li S, Desai M, Hunter C, Rauck R, Kapural L, Nader A, Mak J, Cohen S, Crosby N, Boggs J. Percutaneous peripheral nerve stimulation for the treatment of chronic neuropathic postamputation pain: a multicenter, randomized, placebo-controlled trial. Reg Anesth Pain Med. 2019 Jun;44(6):637-645. doi: 10.1136/rapm-2018-100109. Epub 2019 Apr 5.
PubMed 30954936
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicentre, Randomised Withdrawal Design of a Clinical Trial Evaluating the Safety and Efficacy of a Percutaneous Peripheral Nerve Stimulation System for Patients With Peripheral Neuropathic Pain.
- ClinicalTrials.gov ID
- NCT06290661
- Acronym / sponsor ID
- UHCT-IEC-SOP-016-03-01
- Keywords
- Peripheral Nerve Stimulation, peripheral neuropathic pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, The Second People's Hospital of GuangDong Province, Xiamen Hospital of Traditional Chinese Medicine
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 4 Mar 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.
The goal of this clinical trial is to evaluate safety and efficacy of percutaneous peripheral nerve stimulation in patients with peripheral neuropathic pain. The main questions it aims to answer are:
- The efficacy of percutaneous peripheral nerve stimulation in patients with peripheral neuropathic pain
- The safety of percutaneous peripheral nerve stimulation in patients with peripheral neuropathic pain Participants are going to undergo procedure that implant peripheral nerve stimulation electrode produced by Jiangsu CED Medtech Co., Ltd. Then the subjects, whose VAS scores decrease more 30% than baseline level, are classified into two groups randomly. One of the group receiving active stimulation called trial group and another receiving placebo stimulation called control group. All subjects are required to make their own subjects' pain diary to record VSA score before and after implantation until at the end of follow-up. Also, participants are asked to report use of analgesic medications, number of awakenings and adverse events.
Researchers will compare pain scores between the two groups to see if peripheral nerve stimulation is effective to patients with peripheral neuropathic pain.
Detailed description
The investigators divide study process into 3 main periods called enrollment/baseline period, treatment period and follow-up period. The treatment period is classified into test period, randomized withdrawal period and observation period further.
- Enrollment/baseline period This study will be conducted at four clinical trial sites in China with 3 to 6 subjects included in the pretest and the formal trial planned to enroll 56 subjects. All subjects enter screening process after signing the informed consent form (ICF) approved by the ethics committee. Subjects are enrolled who meet inclusion criteria and do not meet any exclusion criteria. Enrolled subjects will undergo vital signs, physical examination, laboratory tests, and visual analogue scale (VAS) scores for pain for at least 4 days, Neuropathic Pain Scale (DN4), and the Short Form Health Survey (SF-36) as part of the screening period assessment prior to electrode implantation.
- Treatment period 2.1 Implantation of devices Enrolled subjects are implanted with the percutaneous peripheral nerve stimulation system, which was parameterized by the investigator via a programmable controller. Subjects are provided with a "Transcutaneous Peripheral Nerve Stimulation Remote Control Instruction Manual" to guide them in the proper operation and use of the system. 2.2 Test period Investigators will adjust stimulation parameters and record VAS score under different parameters conditions. The enrolled subjects are provided 1 to 5 stimulation therapy patterns parameterized by investigators after the test. Then the subjects receive continuous stimulation with parameterized patterns of 7 (±3) days and VAS scores are be recorded every day of 7 days. Subjects will enter next stage if their VAS scores decrease more than 30% from baseline level or withdraw the trial as reduction less than 30% and devices are removed. 2.3 Randomized withdrawal period Subject will be classified into random group. One of the group receiving active stimulation called trial group and another receiving placebo stimulation called control group. Both of two groups are performed stimulation in the next 7 days. The subjects of control group will get active stimulation again as the VAS scores back to and maintain 2 days at baseline level. VAS scores will be recorded every day during this period. 2.4 Observation period The devices are on work until 28th day after the implantation in trial group; stimulators are turned on after randomized withdrawal period until 28th day after the implantation in control group. All subjects have electrode leads removed on day 28 of implantation or at early withdrawal.
- Follow-up period Investigators will begin follow up as the removal of electrode leads or on the day 28 of implantation. Indicators including VAS score will be evaluated and recorded to assess the efficacy and safety of percutaneous peripheral nerve stimulation during follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants receiving active electrostimulation after implantation procedure | Experimental | Device: Active electrostimulationTwenty-eight participants (anticipated) from different 4 hospital in China whose mean VAS scores decreased more than 30% compared with baseline scores after electrode implantation. They will still receive electrostimulation therapy during randomized withdrawal period. |
| Participants receiving placebo electrostimulation after implantation procedure | Placebo comparator | Device: Placebo electrostimulationTwenty-eight participants (anticipated) from different 4 hospital in China whose mean VAS scores decreased more than 30% compared with baseline scores after electrode implantation. The electrostimulation of them will be turned off during randomized withdrawal period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years old and above, male or female
- Diagnosed by trained clinical doctors as postherpetic neuralgia, which is an indication for peripheral nerve stimulation therapy;
- Assess the damage or disease of the peripheral sensory system through the four questions of Douleur Neuropathy before surgery;
- The subject has received conventional treatment but the efficacy is poor, or cannot tolerate the side effects of conventional treatment;
- Visual analogue scale for pain within 24 hours before surgery ≥ 5;
Key exclusion criteria (12 listed)
- Subjects who need to receive both radio frequency modulation and intrathecal drug infusion treatment simultaneously;
- Subjects who are known to have cardiac implants (pacemakers or defibrillators) or other implantable neural stimulators (spinal cord stimulators or deep brain stimulators, etc.);
- Subjects with severe psychological and/or mental disorders and/or non therapeutic drug dependence;
- Subjects expected to undergo MRI examination within 30 days after PNS implantation;
- Expected to be discharged within 48 hours or less;
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 |
|---|---|---|
| Active electrostimulationMaintain the electrical stimulation state, and according to the patient's feeling to set the appropriate stimulation parameter range (pain relief and no obvious numbness and discomfort), the programme will be written into the patient's self-control remote control, by the patient according to their own pain situation for the independent control of the stimulation current. | Device | Participants receiving active electrostimulation after implantation procedure |
| Placebo electrostimulationNo actual electrostimulation | Device | Participants receiving placebo electrostimulation after implantation procedure |
Primary outcome
Difference in mean pain visual analogue scale VAS scores between trial and control groups in the randomised withdrawal period
Time frame: every day from 7 to 14 days after electrode implantation (randomized withdrawal period)
Researchers will collect visual analogue scale scores of 7 days after the implantation of peripheral nerve stimulation electrode to calculate mean scores of 4 days before randomized withdrawal and evaluate the difference in pain improvement of peripheral nerve stimulation between the two groups (trial and control group) by analyzing the mean change in VAS scores during randomized withdrawal period.
Visual simulation assessment scale collects pain scores after peripheral electrode placement
Time frame: Every day from 7 to 28 days after electrode implantation, as well as the 14th day after electrode removal
Researchers collected daily pain scores from the day of peripheral nerve stimulation electrode implantation until removal using the VAS pain scale, as well as pain scores on the 14th day after electrode removal.
7 secondary outcomes
Proportion of subjects whose pain relief more than 30%
Time frame: Every day for 7 days after electrode implantation (test period)
Proportion of subjects of ideal pain state
Time frame: Every day for 7 days after electrode implantation (test period), every day from 7 to 14 days after electrode implantation (randomized withdrawal period), and every day from 14 to 28 days after electrode implantation (observation period)
Sleep-related assessment after electrostimulation
Time frame: Every day for 7 days after electrode implantation (test period), every day from 7 to 14 days after electrode implantation (randomized withdrawal period), and every day from 14 to 28 days after electrode implantation (observation period)
Change of life quality after electrostimulation
Time frame: 4 days before electrode implantation, 7, 14, 21, 28 days after electrode implantation, and 14 days after electrode removal.
Analgesic medications
Time frame: Every day from 4 days before electrode implantation to 14 days after electrode removal.
Stability of external assistant devices
Time frame: Every day from the 1st to 28th day after electrode implantation, as well as the 14th day after electrode removal.
Questionnaire survey equipment satisfaction
Time frame: On the first day of electrode implantation and the day of electrode removal (remove the electrode 28 days after surgery).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Results publication: PubMed 17258129Mobbs RJ, Nair S, Blum P. Peripheral nerve stimulation for the treatment of chronic pain. J Clin Neurosci. 2007 Mar;14(3):216-21; discussion 222-3. doi: 10.1016/j.jocn.2005.11.007.
- Results publication: PubMed 21422774Al-Jehani H, Jacques L. Peripheral nerve stimulation for chronic neurogenic pain. Prog Neurol Surg. 2011;24:27-40. doi: 10.1159/000323017. Epub 2011 Mar 21.
- Results publication: PubMed 22151211Weiner RL, Reed KL. Peripheral neurostimulation for control of intractable occipital neuralgia. Neuromodulation. 1999 Jul;2(3):217-21. doi: 10.1046/j.1525-1403.1999.00217.x.
- Results publication: PubMed 18164488Slavin KV. Peripheral nerve stimulation for neuropathic pain. Neurotherapeutics. 2008 Jan;5(1):100-6. doi: 10.1016/j.nurt.2007.11.005.
- Results publication: PubMed 30954936Gilmore C, Ilfeld B, Rosenow J, Li S, Desai M, Hunter C, Rauck R, Kapural L, Nader A, Mak J, Cohen S, Crosby N, Boggs J. Percutaneous peripheral nerve stimulation for the treatment of chronic neuropathic postamputation pain: a multicenter, randomized, placebo-controlled trial. Reg Anesth Pain Med. 2019 Jun;44(6):637-645. doi: 10.1136/rapm-2018-100109. Epub 2019 Apr 5.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active electrostimulation in people with Postherpetic Neuralgia and Peripheral Neuropathic Pain, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 6 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 28 Jul 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dong Yang, PHD (13871230491 ext. 86, dongyang118@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in mean pain visual analogue scale VAS scores between trial and control groups in the randomised withdrawal period (time frame: every day from 7 to 14 days after electrode implantation (randomized withdrawal period)). 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?
On the ClinicalTrials.gov record for NCT06290661, which also lists 5 linked publications.
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 28 Jul 2025.