Efficacy of Electroacupuncture in NMOSD Patients With Pain: Study Protocol

Yuanqi Zhao,MD20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. people diagnosed as NMOSD according to the International Panel for NMO Diagnosis (IPND) criteria.\[21\] 2. NRS≥4. 3. people were treated with stable doses of biological therapy and/or prednisone, with no regimen adjustment within 30 days prior to enrollment. 4. people did not adjust any standard pain medication combinations, including antiepileptic drugs, antidepressants, and opioids, within 30 days before enrollment. 5. people or their families provided written informed consent. Exclusion Criteria: 1. people enrolled in other clinical studies. 2. people with low cognitive or mental ability. 3. people who became pregnant during the study period, breastfed, or planned to become pregnant. 4. people with serious diseases related to the heart, liver, kidney or hematopoietic system. 5. people with diabetic peripheral neuropathy.

Outcomes

Primary Outcomes

Short-Form of McGill Pain Questionnaire(SF - MPQ)

higher scores mean a worse outcome.

Time frame: on the baseline

Short-Form of McGill Pain Questionnaire(SF - MPQ)

higher scores mean a worse outcome.

Time frame: through study completion, an average of 1 month

Secondary Outcomes

Expanded Disability Status Scale(EDSS)

higher scores mean a worse outcome.

Time frame: on the baseline

Expanded Disability Status Scale(EDSS)

higher scores mean a worse outcome.

Time frame: through study completion, an average of 1 month

numerical rating scale(NRS)

higher scores mean a worse outcome.

Time frame: on the baseline

numerical rating scale(NRS)

higher scores mean a worse outcome.

Time frame: through study completion, an average of 1 month

Self-Rating Anxiety Scale (SAS)

higher scores mean a worse outcome.

Time frame: on the baseline

Self-Rating Anxiety Scale (SAS)

higher scores mean a worse outcome.

Time frame: through study completion, an average of 1 month

Self-rating Depression Scale (SDS)

higher scores mean a worse outcome.

Time frame: on the baseline

Self-rating Depression Scale (SDS)

higher scores mean a worse outcome.

Time frame: through study completion, an average of 1 month

36-item Short-Form (SF-36)

higher scores mean a better outcome.

Time frame: on the baseline

36-item Short-Form (SF-36)

higher scores mean a better outcome.

Time frame: through study completion, an average of 1 month

Interleukin-6 (IL-6)

higher scores mean a worse outcome.

Time frame: on the baseline

Interleukin-6 (IL-6)

higher scores mean a worse outcome.

Time frame: through study completion, an average of 1 month

tumor necrosis factor-α （TNF-α）

higher scores mean a worse outcome.

Time frame: on the baseline

tumor necrosis factor-α （TNF-α）

higher scores mean a worse outcome.

Time frame: through study completion, an average of 1 month

Efficacy of Electroacupuncture in NMOSD Patients With Pain: Study Protocol

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes