RecruitingNCT05357157

Electroacupuncture Pain Treatment, Mechanical Hyperalgesia, Quality of Life & Expression of Mu+ B Cells in Fibromyalgia

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


Sponsor

University of Crete

Enrollment

80 participants

Start Date

May 31, 2022

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether electroacupuncture (acupuncture with mild electrical stimulation) can reduce pain and improve quality of life for people with fibromyalgia, a condition that causes widespread chronic pain. **You may be eligible if...** - You are over 18 years old - You have been diagnosed with fibromyalgia by a rheumatologist - You have had widespread pain for more than 6 months - If you take medications for fibromyalgia, you have been on a stable dose for at least one month before the study starts **You may NOT be eligible if...** - You have severe depression - You are using biological medications (such as TNF inhibitors) - You have blood disorders or active systemic infections - You are pregnant - You have conditions that prevent safe use of electroacupuncture (such as epilepsy or a pacemaker) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERElectroacupuncture

Subjects will be administered electroacupuncture as described in the electroacupuncture group description

DIETARY_SUPPLEMENTNutrition

Subjects will be administered the intervention described in the electroacupuncture nutrition and dietary supplement group description

DIETARY_SUPPLEMENTDietary supplement

Subjects will be administered the intervention described in the electroacupuncture nutrition and dietary supplement group description


Locations(1)

University Hospital of Heraklion

Heraklion, Greece

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NCT05357157


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