Efficacy of Electroacupuncture in NMOSD Patients With Pain: Study Protocol

Pain Clinical Trial

Official title:

Efficacy of Electroacupuncture in NMOSD Patients With Pain: Study Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05871658
• Other study ID #: 20230221
• Status: Completed
• Phase: N/A
• Start date: March 21, 2022
• Est. completion date: February 21, 2023

Study information

• Verified date: May 2023
• Source: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 21, 2023
• Est. primary completion date: February 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuromyelitis Optica
• Neuromyelitis Optica Spectrum Disorders
• Pain

Intervention

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.

Locations

Country	Name	City	State
China	Guangdong Provincial Hospital of Chinese Medicine	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Yuanqi Zhao,MD

Country where clinical trial is conducted

China, 

Outcome

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