Clinical trial NCT05871658: Efficacy of Electroacupuncture in NMOSD Patients With Pain: Study Protocol
Official title: Efficacy of Electroacupuncture in NMOSD Patients With Pain: Study Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuromyelitis Optica Spectrum Disorders
Pain
Lead sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the electroacupuncture group (experimental group) and the sham electroacupuncture group (control group)
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: Short-Form of McGill Pain Questionnaire(SF - MPQ)
timeFrame: on the baseline
measure: Short-Form of McGill Pain Questionnaire(SF - MPQ)
timeFrame: through study completion, an average of 1 month
Secondary outcomes:
measure: Expanded Disability Status Scale(EDSS)
timeFrame: on the baseline
measure: Expanded Disability Status Scale(EDSS)
timeFrame: through study completion, an average of 1 month
measure: numerical rating scale(NRS)
timeFrame: on the baseline
measure: numerical rating scale(NRS)
timeFrame: through study completion, an average of 1 month
measure: Self-Rating Anxiety Scale (SAS)
timeFrame: on the baseline
measure: Self-Rating Anxiety Scale (SAS)
timeFrame: through study completion, an average of 1 month
measure: Self-rating Depression Scale (SDS)
timeFrame: on the baseline
measure: Self-rating Depression Scale (SDS)
timeFrame: through study completion, an average of 1 month
measure: 36-item Short-Form (SF-36)
timeFrame: on the baseline
measure: 36-item Short-Form (SF-36)
timeFrame: through study completion, an average of 1 month
measure: Interleukin-6 (IL-6)
timeFrame: on the baseline
measure: Interleukin-6 (IL-6)
timeFrame: through study completion, an average of 1 month
measure: tumor necrosis factor-α （TNF-α）
timeFrame: on the baseline
measure: tumor necrosis factor-α （TNF-α）
timeFrame: through study completion, an average of 1 month
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Chinese Medicine
state: Guangdong
Study officials:
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Zhao yuan qi, Dr
role: STUDY_DIRECTOR
References: