Trigeminal Herpetic Neuralgia
Conditions
Keywords
Electroacupuncture, pain, randomized controlled trial, protocol
Brief summary
Trigeminal herpetic neuralgia is a common type of Zoster-associated Pain (ZAP), which troubles individuals in all ages and burdens society all over the world. Eleactroaupuncture (EA) is increasingly used in the treatment of ZAP due to its advantages such as low price, high safety, no adverse reactions, and high patient acceptance. Therefore, it is necessary to conduct randomized controlled trials to evaluate the effectiveness and safety of EA on ZAP and whether EA can be used as a substitute for pregabalin.
Detailed description
Trigeminal herpetic neuralgia is a common type of Zoster-associated Pain (ZAP), which troubles individuals in all ages and burdens society all over the world. Eleactroaupuncture (EA) is increasingly used in the treatment of ZAP due to its advantages such as low price, high safety, no adverse reactions, and high patient acceptance. Therefore, it is necessary to conduct randomized controlled trials to evaluate the effectiveness and safety of EA on ZAP and whether EA can be used as a substitute for pregabalin.
Interventions
OTHERMedication Group
Participants in the medication group would take 150-mg pregabalin capsules (manufactured by Pfizer Pharmaceuticals Co., Ltd) orally twice daily (total daily dose, 300 mg) for 4 weeks.
OTHEREA Group
Acupoints selection: Ashi acupoint, Sibai acupoint (ST2), Xiaguan acupoint (ST7), and Dicang acupoint (ST4) on the affected side. Acupoints for the diseased branches (all taken from the affected side): eye branch and Tongziliao point (GB1), the maxillary branch is taken from the Quanliao point (SI18), and the mandibular branch is taken from the Jiache point (ST6).Shenting point (DU24), Baihui point (DU20), Hegu point (LI4), Waiguan point (TE5), Yanglingquan point (GB34), and Taichong point (LR3) on the affected side Operation: The EA apparatus will be applied on the Ashi point and (LI4 - TE5). The treatment will last for 30 minutes and the electrical stimulation will be set as 2/100Hz in frequency.
OTHEREA+Medication Group
Participants in the EA+Medication group would receive both EA and medical treatement. The acupoints and their location, needles, the settings of the EA device are the same as EA Group's; in the meanwhile, the medication and its dosage is the same as Medication Group's.
Sponsors
The Third Affiliated hospital of Zhejiang Chinese Medical University
The Third People's Hospital of Hangzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. meet the aforementioned diagnostic criteria for trigeminal ZAP, with a disease duration of 1 to 3 months; 2. have a visual analog scale (VAS) score of 4 points ≤ VAS ≤ 7 points; 3. be between 18 and 85 years old, regardless of gender; 4. have clear consciousness, the ability to distinguish pain, and complete basic communication; 5. voluntarily participate in the study, sign a written informed consent form, and fully understand the plan.
Exclusion criteria
1. do not meet the above-mentioned inclusion criteria; 2. have concomitant herpes zoster on the trunk or extremities, or other special types of herpes zoster like meningeal herpes zoster or visceral herpes zoster; 3. are pregnant or lactating patients; 4. are allergic to pregabalin or acupuncture stimulation; 5. have severe organ damage, cognitive dysfunction, mental disorder, aphasia, or other serious diseases that hinder cooperation with treatment; 6. have severe skin diseases; 7. have a pacemaker; 8. have been or are currently participating in other clinical studies within the past 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Score change | Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up) | Intensity of pain range (lately 3 days' average): 0 =no pain to 10 =worst possible pain. Higher score indicating severe pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory Scale (BPI-SF) | Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up) | BPI-SF includes descriptive words such as the cause of pain, nature of pain, impact on life, and location of pain, which are used to describe the degree of pain and evaluate pain in various aspects. |
| Medical Outcomes Study Sleep Scale (MOS-SS) | Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up) | The MOS-SS consists of 12 items related to sleep quality over a 4-week recall period. |
| McGill Pain Questionnaire Short Form (SF-MPQ) | Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up) | SF-MPQ focuses on the characteristics, intensity, syndrome and changes of pain during treatment without taking too much time, so it can sensitively reflect clinical changes and reflect the effectiveness of treatment. |
| Hamilton Depression Rating Scale (HAMD) | Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up) | HAMD will be used to assess the depression status of the participants |
| Short Form 36 Health Survey (SF-36) | Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up) | The SF-36 is a questionnaire with proven reliability and validity and is widely used to assess people's quality of life. |
| Hamilton Depression Rating Scale (HAMD)Hamilton Anxiety Rating Scale (HAMA) | Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up) | HAMA will be used to assess the anxiety status of the participants |
Countries
China
Contacts
Primary ContactPin Lin
Backup ContactChengcheng Kong
Outcome results
None listed