Efficacy of Electroacupuncture in NMOSD Patients With Pain: Study Protocol

Study Overview
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Brief Summary
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Abstract Background Neuropathic pain is a common complication in neuromyelitis optica spectrum disorder (NMOSD), which seriously affects the quality of life of NMOSD patients, with no satisfactory treatment. Through the previous literature study and clinical observation, we found that acupuncture has good curative effect in the treatment of pain, especially electric acupuncture, but thestudies on acupuncture intervention in pain of NMOSD are still scare. Objective To evaluate the clinical efficacy of electroacupuncture on NMOSD patients with pain. Materials and Methods In this exploratory randomized controlled study, NMOSD patients with pain were recruited from March 21, 2022 to February 21, 2023. Patients meeting the inclusion and exclusion criteria were randomly assigned to the electroacupuncture group (experimental group) and the sham electroacupuncture group (control group) by simple random method (envelope method) according to the inclusion order. Totally, there are 20 patients enrolled. The experimental group received electroacupuncture therapy and the control group received sham electroacupuncture therapy. A total of 8 sessions were given twice a week for 30 minutes each. On the baseline, demographic information, medication history, specimens of routine blood, blood biochemistry, liver function, IL - 6, TNF-α were collected, the brain, cervical and thoracic MRI were perfected and collected, patients filled in the SF - MPQ, NRS, SF - 36, SAS, SDS, EDSS. After the treatment, specimens of routine blood, blood biochemistry, liver function, IL - 6, TNF-α were collected again, patients filled in the SF - MPQ, NRS, SF - 36, SAS, SD, EDSS. The main outcome indicators were SF-MPQ, and the secondary outcome indicators were EDSS, NRS, SAS, SDS, SF-36, IL-6, and TNF-α. Conclusion This is the first exploratory randomized controlled study to evaluate the efficacy of electroacupuncture on pain in patients with NMOSD. The study will provide clincial evidence of the practice of electroacupuncture on NMOSD with pain. Key Words neuromyelitis optica spectrum disorders; pain; electroacupuncture

Official Title
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Efficacy of Electroacupuncture in NMOSD Patients With Pain: Study Protocol

Conditions
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Neuromyelitis Optica Spectrum Disorders, Pain

Intervention / Treatment
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* Behavioral: electroacupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: people diagnosed as NMOSD according to the International Panel for NMO Diagnosis (IPND) criteria.[21] NRS≥4. people were treated with stable doses of biological therapy and/or prednisone, with no regimen adjustment within 30 days prior to enrollment. people did not adjust any standard pain medication combinations, including antiepileptic drugs, antidepressants, and opioids, within 30 days before enrollment. people or their families provided written informed consent. Exclusion Criteria: people enrolled in other clinical studies. people with low cognitive or mental ability. people who became pregnant during the study period, breastfed, or planned to become pregnant. people with serious diseases related to the heart, liver, kidney or hematopoietic system. people with diabetic peripheral neuropathy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: the electroacupuncture group (experimental group) and the sham electroacupuncture group (control group)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the electroacupuncture group<br>electroacupuncture were inserted into bilateral Zusanli (ST36), Sanyinjiao (SP6), Hegu (LI4) and Quchi (LI11), and Yintang (EX-HN3). Electroacupuncture parameters selected the sparse wave, the frequency was 4 Hz, the stimulation intensity was tolerated by the patient. | Behavioral: electroacupuncture<br>* electroacupuncture were inserted into bilateral Zusanli (ST36), Sanyinjiao (SP6), Hegu (LI4) and Quchi (LI11), and Yintang (EX-HN3). Electroacupuncture parameters selected the sparse wave, the frequency was 4 Hz, the stimulation intensity was tolerated by the patient.<br>|
| Sham Comparator: the sham electroacupuncture group<br>According to the previous trial,[19] sham acupoints were 1cm away from the level of the acupoints used in the EA group, which avoided the area corresponding to any of the 14 meridians of TCM. The insertion of the needle was shallower (less than 0.2cm) and had similar pain to that of normal needle insertion. The stimulation intensity was 0mA. However, the model of electroacupuncture, the frequency, and duration of treatment in the SEA group were identical in the TA group. | Behavioral: electroacupuncture<br>* electroacupuncture were inserted into bilateral Zusanli (ST36), Sanyinjiao (SP6), Hegu (LI4) and Quchi (LI11), and Yintang (EX-HN3). Electroacupuncture parameters selected the sparse wave, the frequency was 4 Hz, the stimulation intensity was tolerated by the patient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-Form of McGill Pain Questionnaire(SF - MPQ) | higher scores mean a worse outcome. | on the baseline | 
| Short-Form of McGill Pain Questionnaire(SF - MPQ) | higher scores mean a worse outcome. | through study completion, an average of 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expanded Disability Status Scale(EDSS) | higher scores mean a worse outcome. | on the baseline | 
| Expanded Disability Status Scale(EDSS) | higher scores mean a worse outcome. | through study completion, an average of 1 month | 
| numerical rating scale(NRS) | higher scores mean a worse outcome. | on the baseline | 
| numerical rating scale(NRS) | higher scores mean a worse outcome. | through study completion, an average of 1 month | 
| Self-Rating Anxiety Scale (SAS) | higher scores mean a worse outcome. | on the baseline | 
| Self-Rating Anxiety Scale (SAS) | higher scores mean a worse outcome. | through study completion, an average of 1 month | 
| Self-rating Depression Scale (SDS) | higher scores mean a worse outcome. | on the baseline | 
| Self-rating Depression Scale (SDS) | higher scores mean a worse outcome. | through study completion, an average of 1 month | 
| 36-item Short-Form (SF-36) | higher scores mean a better outcome. | on the baseline | 
| 36-item Short-Form (SF-36) | higher scores mean a better outcome. | through study completion, an average of 1 month | 
| Interleukin-6 (IL-6) | higher scores mean a worse outcome. | on the baseline | 
| Interleukin-6 (IL-6) | higher scores mean a worse outcome. | through study completion, an average of 1 month | 
| tumor necrosis factor-α （TNF-α） | higher scores mean a worse outcome. | on the baseline | 
| tumor necrosis factor-α （TNF-α） | higher scores mean a worse outcome. | through study completion, an average of 1 month |