NCT05357157 Electroacupuncture Pain Treatment, Mechanical Hyperalgesia, Quality of Life & Expression of Mu+ B Cells in Fibromyalgia
| NCT ID | NCT05357157 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Crete |
| Condition | Fibromyalgia |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2022-05-31 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2022-05-31 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Fibromyalgia (FM) is a complex, multifactorial syndrome characterized by widespread chronic pain with hyperal- gesia and allodynia and a constellation of somatic and psychological manifestations, including fatigue, sleep dis- orders, depression, anxiety, gastrointestinal and cognitive disorders. FM is now recognized as one of the most common chronic pain conditions and its management remains a challenge for patients and healthcare profes- sionals. The fact that FM is associated with chronic pain without any obvious peripheral tissue damage has given rise to the concept of nociplastic pain with evidence of dysfunction in mono-aminergic neurotransmission, lead- ing to elevated levels of excitatory neurotransmitters and decreased levels of serotonin and norepinephrine in the spinal cord at the level of descending anti-nociceptive pathways. Additionally, dopamine dysregulation and altered activity of endogenous cerebral opioids have been observed in FM. Recent European guidelines on FM treatment emphasize that there should be a comprehensive assessment of patient's pain, function and psychosocial context. It is recognized that there are profound and fundamental problems associated with the pain assessment tools in common use, as most of these represent an attempt to reduce a multidimensional experience to a coarse unidimensional measure. Use of multiple tools for sub- jective and objective assessment of pain may reflect more accurately patient's pain experience. Furthermore, tracing a biologic pain marker in FM patients would facilitate both the initial assessment of pain and the re- sponse to treatment. Management of pain in FM patients should focus first on non-pharmacological modalities. Acupuncture therapy is an effective and safe treatment and exerts its analgesic effect through activation of pe- ripheral and central pain control systems with the release of β-endorphins, enkephalins, dynorphins, serotonin, norepinephrine, γ-aminobutyric acid or ATP. The aim of our study is to assess initially reported pain and evaluate the effectiveness of electroacupuncture (with or without diet modifications) on the "whole experience of pain" in FM patients in a multimodel assessment frame.
Eligibility Criteria
Inclusion Criteria: * Patient's consent * Age \>18 years old * Patients with diagnosed fibromyalgia from rheumatologists * Widespread pain more than 6 months * In case of drug therapy, it should be taken at least one month before the beginning of the session and remain stable till the end of the study Exclusion Criteria: * Deep depression * Biological agent use ( TNF inhibitors) * Heamatological diseases * Systemic Infections * pregnancy * electroacupuncture contraindications (epilepsy, pacemaker/ implantable cardioverter defibrillator (ICD)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05357157 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Fibromyalgia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05357157 currently recruiting?
Yes, NCT05357157 is actively recruiting participants. Contact the research team at vnyktari@gmaill.com for enrollment information.
Where is the NCT05357157 trial being conducted?
This trial is being conducted at Heraklion, Greece.
Who is sponsoring the NCT05357157 clinical trial?
NCT05357157 is sponsored by University of Crete. The trial plans to enroll 80 participants.
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