NCT05357157

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

Recruiting now Last updated 26 October 2022

What this trial tests

trial testing Electroacupuncture in Fibromyalgia in 80 participants. Currently enrolling.

Timeline

31 May 2022

Primary endpoint
1 December 2025

1 December 2026

Quick facts

Lead sponsor	University of Crete
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	80
Start date	31 May 2022
Primary completion	1 December 2025
Estimated completion	1 December 2026
Sites	1 location across Greece

Drugs / interventions tested

• Electroacupuncture
• Nutrition
• Dietary supplement — full drug profile →

Conditions studied

• Fibromyalgia — all drugs for Fibromyalgia →
• Electroacupuncture — all drugs for Electroacupuncture →
• Acupuncture — all drugs for Acupuncture →
• Hyperalgesia — all drugs for Hyperalgesia →

Sponsor

University of Crete

Who can join

Adults 18 to 80, any sex, with Fibromyalgia or Electroacupuncture. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Palmitoylethanolamide in the Treatment of Pain and Its Clinical Application Prospects.
   Wang Y, Duan X, Li Z, Pan Y, et al · · 2025 · PMID 40827226 · DOI 10.2147/dddt.s540327