Relapsing-Remitting Multiple Sclerosis
Conditions
Interventions
Electroacupuncture Control Group:Sham Acupuncture+Conventional Western medicine treatment
Electroacupuncture Group:Electroacupuncture+Conventional Western medicine treatment
Sponsors
he Third Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
20 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) All included patients meet the 2017 revised McDonald criteria for MS diagnosis and the 2018 Chinese expert consensus on multiple sclerosis diagnosis. Patients with other autoimmune diseases or stress-related disorders are excluded and all are in remission (Relapsing-Remitting type). (2) Age between 20 and 60 years both males and females are eligible. (3) Patients who have had more than 2 documented relapses in the past 3 years and at least one relapse within the past year. (4) Expanded Disability Status Scale (EDSS) score = 5. (5) MRI shows characteristic features with multiple long T1 and long T2 abnormal signals in the white matter with lesions typically < 10 cm in diameter generally ranging from 0.3 to 10 cm. These lesions are scattered around the periventricular area corpus callosum brainstem and cerebellum with a few located at the gray-white matter junction. Periventricular lesions are oval or linear with their long axis perpendicular to the sagittal plane of the skull. Spinal cord lesions are commonly found in the cervical and thoracic segments with various shapes such as scattered small dots plaques round or oval shapes and a few irregular or plate-like lesions some of which may merge. (6) Subjects with metal dentures pacemakers or other foreign objects are excluded. (7) Subjects must have adequate understanding and reading ability capable of correctly understanding the relevant content of the scales and providing answers. (8) Good compliance and willingness to cooperate with the study with patients signing the informed consent form. (9) The informed consent process must comply with the relevant Good Clinical Practice (GCP) regulations. Note: Only patients who meet all the above 9 criteria will be included in this study.
Exclusion criteria
Exclusion criteria: (1) Patients with primary progressive secondary progressive or progressive-relapsing multiple sclerosis (MS). (2) Patients with a history of allergies to any medications used in this study or those who cannot tolerate acupuncture therapy. (3) Patients who have been treated with disease-modifying drugs within 6 monthsPatients with any clinically significant history of diseases or other major primary diseases or psychiatric disorders including: 1) HIV infection or active hepatitis A or syphilis infection; history or signs of immunodeficiency; 2) Epilepsy that is not adequately controlled by treatment; 3) Clinically significant heart disease such as uncontrolled arrhythmia uncontrolled angina cardiomyopathy or uncontrolled congestive heart failure; 4) A history of severe depression or suicide attempts or currently having suicidal tendencies; 5) History of malignancy hepatitis B or other major diseases like connective tissue diseases granulomatous diseases tumors or genetic metabolic disorders. (4) Pregnant or breastfeeding women or patients who plan to become pregnant within the last 3 months. (5) Later diagnosis of other demyelinating diseases (such as acute disseminated encephalomyelitis neuromyelitis optica spectrum disorder myelin oligodendrocyte glycoprotein IgG antibody-associated disease demyelinating pseudotumor or myelitis) cerebrovascular diseases (such as multiple lacunar cerebral infarcts vascular malformations or moyamoya disease) infectious diseases connective tissue diseases granulomatous diseases tumor diseases or genetic metabolic diseases. Note: Any patient who meets any one of the above criteria will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expanded Disability Status Scale(EDSS); | — |
Secondary
| Measure | Time frame |
|---|---|
| 9-Hole Peg Test(9-HPT);Hamilton Anxiety Scale(HAMA);blood routine examination+CRP;Magnetic ResonanceImaging(MRI));Motor Evoked Potential (MEP);Somatosensory evoked potential;Hamilton Depression Scale;The 12-Item MS Walking ScaleMSWS-12;The Symbol Digit Modalities Test (SDMT); | — |
Countries
China
Contacts
Public ContactYangSha
The Third Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Outcome results
None listed