Efficacy of Electroacupuncture in NMOSD Patients With Pain: Study Prot
Efficacy of Electroacupuncture in NMOSD Patients With Pain: Study Protocol
We could not find results for this trial
What it found
We found no results in the registry or in papers.
This trial finished 3 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- electroacupuncture
What it measured
Main measures
Short-Form of McGill Pain Questionnaire(SF - MPQ)
on the baseline
PainShort-Form of McGill Pain Questionnaire(SF - MPQ)
through study completion, an average of 1 month
Pain
Other measures (14)
Expanded Disability Status Scale(EDSS)
on the baseline
Disability progressionExpanded Disability Status Scale(EDSS)
through study completion, an average of 1 month
Disability progressionnumerical rating scale(NRS)
on the baseline
numerical rating scale(NRS)
through study completion, an average of 1 month
Self-Rating Anxiety Scale (SAS)
on the baseline
Mood and sleepSelf-Rating Anxiety Scale (SAS)
through study completion, an average of 1 month
Mood and sleepSelf-rating Depression Scale (SDS)
on the baseline
Mood and sleepSelf-rating Depression Scale (SDS)
through study completion, an average of 1 month
Mood and sleep36-item Short-Form (SF-36)
on the baseline
Quality of life (reported by participants)36-item Short-Form (SF-36)
through study completion, an average of 1 month
Quality of life (reported by participants)
Who could take part
NMOSD · 18 to 80
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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
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History
Started
Mar 2022
Main results due
Feb 2023
Finished
Feb 2023