Efficacy of Electroacupuncture in NMOSD Patients With Pain: Study Protocol

May 20, 2023 updated by: Yuanqi Zhao,MD

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Guangdong Provincial Hospital of Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: the electroacupuncture group
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
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.
Sham Comparator: the sham electroacupuncture group
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
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuanqi Zhao,MD

Investigators

  • Study Director: Zhao yuan qi, Dr, Guangdong Provincial Hospital of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2022

Primary Completion (Actual)

February 21, 2023

Study Completion (Actual)

February 21, 2023

Study Registration Dates

First Submitted

April 20, 2023

First Submitted That Met QC Criteria

May 20, 2023

First Posted (Actual)

May 23, 2023

Study Record Updates

Last Update Posted (Actual)

May 23, 2023

Last Update Submitted That Met QC Criteria

May 20, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230221

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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