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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Greece
University Hospital of Heraklion
RECRUITING
Heraklion
Contact Information
Primary
Vasileia Nyktari
vnyktari@gmaill.com
+302810392994
Backup
Papaioannou
+302810392994
Time Frame
Start Date: 2022-05-31
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 80
Treatments
Electroacupuncture
All subjects will be administered electroacupuncture sessions Acupoints that will be used: Baihui, Yin tang, BL-10, GB21, SI13, BL-60, ST-36, LV-3, LV8, Spl 6, LI-4, LI11, Kid 3, Ren 6, Heart 7
Electroacupuncture, Nutrition and Dietary supplement
All subjects will be administered electroacupuncture sessions Acupoints that will be used: Baihui, Yin tang, BL-10, GB21, SI13, BL-60, ST-36, LV-3, LV8, Spl 6, LI-4, LI11, Kid 3, Ren 6, Heart 7. Patients will be presented with the option to be prescribed a dietary supplement containing vitamin B complex, Mg, Zn, superoxide dismutase, Alpha Lipoic Acid and PalmitoylethanolamideAdditionally they will be given a specific anti-intiflamatory dietary regimen to follow.
Related Therapeutic Areas
Sponsors
Leads: University of Crete
Collaborators: University Hospital of Crete

This content was sourced from clinicaltrials.gov