fibromyalgia syndrome (FMS)
Conditions
Interventions
TEA group:Treatment with TEA will be administered twice daily for 30 minutes per session, over 14 days. The TEA will utilize a 15 Hz frequency with a 0.5 ms pulse width.During each treatment session,
sham-TEA group:Treatment with sham-TEA will be administered twice daily for 30 minutes per session, over 14 days. The sham-TEA parameters are: 15 Hz frequency, 0.5 ms pulse width, with a 2-second ON a
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1)18 years=Age =80 years. 2)Meets Wolfe 2016 diagnostic criteria for FMS . 3)VAS=3 scores4)Volunteer for this clinical study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1)The state of electronic devices such as pacemakers and brain nerve stimulators etc. 2)Serious damage to the heart liver or kidneys or mental disorders or failure to cooperate with examination and treatment. 3)Women in pregnancy4)Active malignant tumor. 5) Fragile skin prone to bleeding rupture allergies etc. 6)Used TEA in the last 3 months. 7)Participation in other clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| visual analogue scale(VAS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain Fatigue Sleep and Concurrent Medications During the Treatment Period;PROMIS Sleep-Related Impairment 8a scales;Systemic Accompanying Symptoms and Traditional Chinese Medicine (TCM) Information Collection (Factors Worsening or Relieving Pain Physical Strength Tongue and Pulse Conditions Sweating Hot or Cold Sensations Unusual Mouth Odor Bowel and Urinary Conditions Diet Sleep Emotions TCM Syndrome Differentiation etc.);Cytokines;liver stiffness measurement LSM;Medical History (Current Medical History Past Medical History Personal History Allergy History Menstrual History Family History etc.);Patient Health Questionnaire-9;Brief Pain Inventory (BPI);S100 calcium-binding protein B (S100B);Infrared thermal imager detects temperature;Individual assessment of treatment by subjects;(brain-derived neurotrophic factor BDNF);Fibromyalgia Survey Questionnaire (FSQ);12–items Short Form Health Survey;Inquire which group the patient believes they belong to.;Calcitonin gene related peptide(CGRP);Body Data MeasurementCoordinationCognition;Translocator protein(TSPO);Metabonomics;The Patient-Reported Outcomes Measurement Information System® (PROMIS)-Fatigue Short Form 7a (SF-7a) scale;Concurrent Medications and Treatment;General Information (Age Gender Ethnicity Marital Status Occupation Education etc.); | — |
Countries
China
Contacts
Public ContactYifan Li
China-Japan Friendship Hospital
Outcome results
None listed