Actively Recruiting
Effect of Electroacupuncture Treatment on Pain, Mechanical Hyperalgesia, Quality of Life and Expression of Mu+ B Cells in Patients With Fibromyalgia: A Prospective Observational Study
Led by University of Crete · Updated on 2022-10-26
80
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Crete
Lead Sponsor
U
University Hospital of Crete
Collaborating Sponsor
AI-Summary
What this Trial Is About
Fibromyalgia (FM) is a complex chronic pain condition characterized by widespread pain, fatigue, sleep problems, and psychological symptoms such as depression and anxiety. It involves changes in brain and nerve chemical signals related to pain control. This research aims to evaluate how electroacupuncture, alone or combined with diet changes, affects the overall experience of pain in FM patients using multiple assessment tools. Participants will receive electroacupuncture treatments targeting specific acupoints. Some will also have the option to follow a special anti-inflammatory diet and take dietary supplements including vitamin B complex, magnesium, zinc, and others. The study will track changes in pain and biological markers at various points: baseline, after 6 and 12 treatment sessions, and six months after treatment ends. Throughout the study, patients will undergo assessments including measurement of Mu-positive B cells (a potential pain biomarker), pressure pain thresholds using an algometer at different body sites, symptom severity scales, quality of life questionnaires, and depression screening. These evaluations occur at baseline, during treatment, and at follow-ups up to six months after completing electroacupuncture. The study aims to provide a comprehensive view of pain and its changes in FM patients receiving this treatment.
CONDITIONS
Brief Title
Electroacupuncture Pain Treatment, Mechanical Hyperalgesia, Quality of Life & Expression of Mu+ B Cells in Fibromyalgia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient's consent
- Age over 18 years
- Diagnosed fibromyalgia by a rheumatologist
- Widespread pain for more than 6 months
- Stable drug therapy for at least one month before starting the study
You will not qualify if you...
- Deep depression
- Use of biological agents such as TNF inhibitors
- Hematological diseases
- Systemic infections
- Pregnancy
- Contraindications to electroacupuncture including epilepsy and presence of pacemaker or implantable cardioverter defibrillator (ICD)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive electroacupuncture sessions targeting specific acupoints. Some participants may also follow a prescribed dietary supplement and anti-inflammatory diet.
12 electroacupuncture sessions over 6 weeks
Duration - 6 months
Participants are assessed for pain, quality of life, and biological markers up to 6 months after completing electroacupuncture treatment.
Follow-up visits at 3 and 6 months after treatment completion
Trial Site Locations
Total: 1 location
1
University Hospital of Heraklion
Heraklion, Greece, 700 13
Actively Recruiting
Research Team
V
Vasileia Nyktari
P
Papaioannou
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here