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CompletedNCT05871658Updated May 23, 2023

Efficacy of Electroacupuncture in NMOSD Patients With Pain: Study Protocol

An interventional study of electroacupuncture in Neuromyelitis Optica Spectrum Disorders and Pain, sponsored by Yuanqi Zhao,MD. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-05-23.

Sponsored by Yuanqi Zhao,MD · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Mar 2022, registered Apr 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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

02

Conditions studied

  • Neuromyelitis Optica Spectrum Disorders
  • Pain

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03

In context

Neuromyelitis Optica

162 studies on the registry are indexed under Neuromyelitis Optica; 72 are open to participants now.

This study's enrollment of 20 is below the median of 25 across 97 interventional studies indexed under Neuromyelitis Optica.

Browse Neuromyelitis Optica studies →

Lead sponsor

This is the only study on the registry with Yuanqi Zhao,MD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
20 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Behavioralelectroacupuncture

    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.

06

What researchers measure

Primary outcomes

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

    higher scores mean a worse outcome.

    Time frame: on the baseline

  2. 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

  1. Expanded Disability Status Scale(EDSS)

    higher scores mean a worse outcome.

    Time frame: on the baseline

  2. Expanded Disability Status Scale(EDSS)

    higher scores mean a worse outcome.

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

  3. numerical rating scale(NRS)

    higher scores mean a worse outcome.

    Time frame: on the baseline

  4. numerical rating scale(NRS)

    higher scores mean a worse outcome.

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

  5. Self-Rating Anxiety Scale (SAS)

    higher scores mean a worse outcome.

    Time frame: on the baseline

  6. Self-Rating Anxiety Scale (SAS)

    higher scores mean a worse outcome.

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

  7. Self-rating Depression Scale (SDS)

    higher scores mean a worse outcome.

    Time frame: on the baseline

  8. Self-rating Depression Scale (SDS)

    higher scores mean a worse outcome.

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

  9. 36-item Short-Form (SF-36)

    higher scores mean a better outcome.

    Time frame: on the baseline

  10. 36-item Short-Form (SF-36)

    higher scores mean a better outcome.

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

  11. Interleukin-6 (IL-6)

    higher scores mean a worse outcome.

    Time frame: on the baseline

  12. Interleukin-6 (IL-6)

    higher scores mean a worse outcome.

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

  13. tumor necrosis factor-α （TNF-α）

    higher scores mean a worse outcome.

    Time frame: on the baseline

  14. tumor necrosis factor-α （TNF-α）

    higher scores mean a worse outcome.

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

07

Study locations

1 site
  • Guangdong Provincial Hospital of Chinese Medicine
    Guangzhou, Guangdong 510000, China
08

References and documents

Study documents

  • Study protocol · Mar 1, 2022
  • Informed consent form · Mar 1, 2022

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05871658
Lead sponsor
Yuanqi Zhao,MD
Responsible party
Yuanqi Zhao,MD (director, Guangdong Provincial Hospital of Traditional Chinese Medicine) — Sponsor-investigator
First posted
May 23, 2023
Start date
Mar 21, 2022
Primary completion
Feb 21, 2023
Completion
Feb 21, 2023
Last update
May 23, 2023

Study contacts

Zhao yuan qi, Dr
study director · Guangdong Provincial Hospital of Traditional Chinese Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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