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| Name | Class |
|---|---|
| Lishui Hospital of Traditional Chinese Medicine | UNKNOWN |
| Zhejiang Provincial Tongde Hospital | OTHER |
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Postherpetic neuralgia (PHN) has a high incidence rate and severely impact on quality of life and health care costs, interfering with physical, emotional and social functioning of affected patients. Current therapeutic options for PHN mainly include analgetic and local anaesthesia for selective nerve blockade. Nevertheless, the efficacy of analgetic is always limited by inevitable side effects, in which patients have poor compliance. Moreover, for some most suffering patients, the control of pain is often unsatisfactory despite the administration of complex combinations. As a non-pharmarceutical therapy, acupuncture is widely use for a wide range of pain conditions. Thus, it might be an alternative treatment for PHN. The aim of this multicenter randomized controlled trial is to investigate the efficacy and safety of electroacupuncture therapy in patients with postherpetic neuralgia.
This randomized controlled trial will enroll 132 patients with postherpetic neuralgia. All patients will be randomly assigned to either the EA combined with medication group or the medication group via a computerized central randomization system in a 1:1 ratio. Primary outcomes will be change in sensory thresholds and pain intensity. Secondary outcomes will be change in dosage of analgetic, quality of life, anxiety and depression severity and sleep quality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EA combined with medication group | Experimental | Patients in this group will receive electroacupuncture combined with gabapentin. |
|
| Medication group | Active Comparator | Participants in this group will only receive gabapentin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EA combined with medication | Procedure | Primary acupoints include Ashi points, Jiaji acupoints and Xi-cleft points. Jiaji points on the ipsilateral side will be selected according to the corresponding ganglia involved by HZ. Xi-cleft points will be selected based on the distribution regions of PHN. For pain sites that mainly distributed in the gallbladder meridian, GB36 will be selected. For pain sites that mainly distributed in the stomach meridian, ST34 will be selected. For pain sites that mainly distributed in the gallbladder meridian, BL63 will be selected. For pain sites that mainly distributed in the large intestine meridian, LI7 will be selected. Supplementary acupoints will be chosen based on TCM syndrome differentiation. Operation: Two paired of acupoints are connected to the EA apparatus. EA parameter is selected as 2/100Hz wave. EA intensity is selected according to the patients' endurance. Needles will be retained and EA will last for 30 mins for each session. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in sensory thresholds | Sensory thresholds is measured by quantitative sensory testing | before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up |
| Change in pain intensity | Pain intensity is measured by Zoster Brief Pain Inventory (ZBPI) | before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in dosage of analgetic | Dosage of analgetic | before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up |
| Change in score of quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dexiong Han, M.D | The Third Affiliated hospital of Zhejiang Chinese Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Affiliated Hospital of Zhejiang Chinese Medical university | Hangzhou | Zhejiang | 310000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29431387 | Background | Saguil A, Kane S, Mercado M, Lauters R. Herpes Zoster and Postherpetic Neuralgia: Prevention and Management. Am Fam Physician. 2017 Nov 15;96(10):656-663. | |
| 25317872 | Background | Johnson RW, Rice AS. Clinical practice. Postherpetic neuralgia. N Engl J Med. 2014 Oct 16;371(16):1526-33. doi: 10.1056/NEJMcp1403062. No abstract available. |
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| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
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| Medication | Drug | The dosage of gabapentin starts from 100mg Tid. 100mg-300mg can be increased every 3-7 days and taken in three doses, but the total amount is not more than 1800mg/day. The dosage of gabapentin will be adjusted according to the patient's condition until his pain is effectively controlled. After maintaining the medication for two weeks, the dosage can be gradually reduced and 100mg can be reduced every 3-7 days. |
|
Quality of life is measure by 36-item Short Form Health Survey (SF-36)
| before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up |
| Change in score of anxiety and depression severity | Anxiety and depression severity is measure by Hospital Anxiety and Depression Scale (HADS) | before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up |
| Change in score of sleep quality | Sleep quality is measured by Pittsburgh Sleep Quality Index (PSQI) | before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up |
| Adverse events | Incidence of adverse events | Up to 6 weeks of treatment |
| 26218719 | Background | Forbes HJ, Thomas SL, Smeeth L, Clayton T, Farmer R, Bhaskaran K, Langan SM. A systematic review and meta-analysis of risk factors for postherpetic neuralgia. Pain. 2016 Jan;157(1):30-54. doi: 10.1097/j.pain.0000000000000307. |
| 31151330 | Background | Lin CS, Lin YC, Lao HC, Chen CC. Interventional Treatments for Postherpetic Neuralgia: A Systematic Review. Pain Physician. 2019 May;22(3):209-228. |
| 30142834 | Background | Wang Y, Li W, Peng W, Zhou J, Liu Z. Acupuncture for postherpetic neuralgia: Systematic review and meta-analysis. Medicine (Baltimore). 2018 Aug;97(34):e11986. doi: 10.1097/MD.0000000000011986. |
| 28712474 | Background | Avijgan M, Hajzargarbashi ST, Kamran A, Avijgan M. Postherpetic Neuralgia: Practical Experiences Return to Traditional Chinese Medicine. J Acupunct Meridian Stud. 2017 Jun;10(3):157-164. doi: 10.1016/j.jams.2017.02.003. Epub 2017 Feb 28. |
| 32891279 | Background | Ruengwongroj P, Muengtaweepongsa S, Patumanond J, Phinyo P. Effectiveness of press needle treatment and electroacupuncture in patients with postherpetic neuralgia: A matched propensity score analysis. Complement Ther Clin Pract. 2020 Aug;40:101202. doi: 10.1016/j.ctcp.2020.101202. Epub 2020 May 25. |
| 32762718 | Background | Zhang Y, Liang Z, Li S, Yang L, Guo T, Xu Y, Yang J, Xu Q, Zhang Q, Zhao J, Li C, Liu X. Fire needle plus cupping for acute herpes zoster: study protocol for a randomized controlled trial. Trials. 2020 Aug 6;21(1):701. doi: 10.1186/s13063-020-04599-2. |
| 32227773 | Background | Wang L, Qiu L, Zheng X, Ouyang J, Zhang M, He L, Zeng S, Liu B, Peng J. Effectiveness of electroacupuncture at Jiaji acupoints (EX-B2), plus moxibustion and intermediate on postherpetic neuralgia: a randomized controlled trial. J Tradit Chin Med. 2020 Feb;40(1):121-127. |
| 31410050 | Background | Pei W, Zeng J, Lu L, Lin G, Ruan J. Is acupuncture an effective postherpetic neuralgia treatment? A systematic review and meta-analysis. J Pain Res. 2019 Jul 16;12:2155-2165. doi: 10.2147/JPR.S199950. eCollection 2019. |
| 31534360 | Background | Liu K, Zeng J, Pei W, Chen S, Luo Z, Lu L, Lin G. Assessing the reporting quality in randomized controlled trials of acupuncture for postherpetic neuralgia using the CONSORT statement and STRICTA guidelines. J Pain Res. 2019 Jul 29;12:2359-2370. doi: 10.2147/JPR.S210471. eCollection 2019. |
| 34095161 | Derived | Hu H, Shen Y, Li X, Tian H, Li X, Li Y, Cheng Y, Wu L, Han D. Efficacy of Electroacupuncture Therapy in Patients With Postherpetic Neuralgia: Study Protocol for a Multicentre, Randomized, Controlled, Assessor-Blinded Trial. Front Med (Lausanne). 2021 May 21;8:624797. doi: 10.3389/fmed.2021.624797. eCollection 2021. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |