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

Conditions studied

Fibromyalgia, Electroacupuncture, Acupuncture, Hyperalgesia

About this study

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.

Interventions

• Other: Electroacupuncture — Subjects will be administered electroacupuncture as described in the electroacupuncture group description
• Dietary Supplement: Nutrition — Subjects will be administered the intervention described in the electroacupuncture nutrition and dietary supplement group description
• Dietary Supplement: Dietary supplement — Subjects will be administered the intervention described in the electroacupuncture nutrition and dietary supplement group description

Primary outcomes

• MOR - positive Bcells - baseline (Baseline)
• MOR - positive Bcells - 6th session of electroacupuncture (End of 6th session of electroacupuncture- 3 weeks after baseline)
• MOR - positive Bcells - 12th session of electroacupuncture (End of 12th session of electroacupuncture - 6 weeks after baseline)
• MOR - positive Bcells - 6 months after the end of the 12th session (6 months after the end of 12th session of electroacupuncture)

Eligibility information

Study locations

• University Hospital of Heraklion, Heraklion, 700 13 Greece