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

NCT05357157 | Recruiting

• 1 other identifier: Acupuncture - Fibromyalgia
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Electroacupuncture; Acupuncture; Hyperalgesia

Keywords

Fibromyalgia; Chronic Pain; Electroacupuncture; Acupuncture; Palmitoylethanolamide; MOR-Positive B Cell; Hyperalgesia; Quality of life; Pressure Algometry; Anti-inflammatory Nutrition; Depression

Outcome Measures

Primary Outcomes (4)

• MOR - positive Bcells - baseline

  Patients' blood samples will be collected prior to the intervention to serve as a baseline. Flow cytometry immunophenotyping will be performed on the samples to determine the percentage of MOR positive B cells. Data will be reported as a percentage of the total B cell number.

  Baseline

• MOR - positive Bcells - 6th session of electroacupuncture

  Patients' blood samples will be collected at the end of the 6th session of electroacupuncture. All patients will undergo electroacupuncture sessions twice a week, and the first 6 electroacupuncture sessions will take place within 3 weeks. Flow cytometry immunophenotyping will be performed on the samples to determine the percentage of MOR positive B cells. Data will be reported as a percentage of the total B cell number.

  End of 6th session of electroacupuncture- 3 weeks after baseline

• MOR - positive Bcells - 12th session of electroacupuncture

  Patients' blood samples will be collected at the end of the 12th session of electroacupuncture. All patients will undergo electroacupuncture sessions twice a week, and all 12 electroacupuncture sessions will take place within 6 weeks. Flow cytometry immunophenotyping will be performed on the samples to determine the percentage of MOR positive B cells. Data will be reported as a percentage of the total B cell number.

  End of 12th session of electroacupuncture - 6 weeks after baseline

• MOR - positive Bcells - 6 months after the end of the 12th session

  Patients' blood samples will be collected 6 months after the end of the 12th session of electroacupuncture. All patients will undergo electroacupuncture sessions twice a week, and all 12 electroacupuncture sessions will take place within 6 weeks. Patients will undergo no more electroacupuncture sessions after the 12th session. Flow cytometry immunophenotyping will be performed on the samples to determine the percentage of MOR positive B cells. Data will be reported as a percentage of the total B cell number.

  6 months after the end of 12th session of electroacupuncture

Secondary Outcomes (35)

• Pain estimation with Pressure algometer - baseline (trapezius)

  baseline

• Pain estimation with Pressure algometer - baseline (supraspinatus)

  baseline

• Pain estimation with Pressure algometer - baseline (tibia)

  baseline

• Pain estimation with Pressure algometer - 6th session of electroacupuncture (trapezius)

  end of 3rd week of electroacupuncture

• Pain estimation with Pressure algometer - 6th session of electroacupuncture (supraspinatus)

  end of 3rd week of electroacupuncture

Study Arms (2)

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

Other: Electroacupuncture

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.

Other: Electroacupuncture; Dietary Supplement: Nutrition; Dietary Supplement: Dietary supplement

Interventions

Electroacupuncture OTHER

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

Electroacupuncture; Electroacupuncture, Nutrition and Dietary supplement

Nutrition DIETARY_SUPPLEMENT

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

Electroacupuncture, Nutrition and Dietary supplement

Dietary supplement DIETARY_SUPPLEMENT

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

Electroacupuncture, Nutrition and Dietary supplement

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients will be referred from Rheumatology clinic with an established primary fibromyalgia diagnosis

You may qualify if:

• 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

You may not qualify if:

• Deep depression
• Biological agent use ( TNF inhibitors)
• Heamatological diseases
• Systemic Infections
• pregnancy
• electroacupuncture contraindications (epilepsy, pacemaker/ implantable cardioverter defibrillator (ICD)

Sponsors & Collaborators

• University of Crete: lead
• University Hospital of Crete: collaborator

Study Sites (1)

University Hospital of Heraklion

Heraklion, 700 13, Greece

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be taken from patients at the following time periods: 1. Before the 1st session of electroacupuncture 2. after the 12th session of electroacupuncture 3. 6 months after the last session of electroacupuncture

MeSH Terms

Conditions

Fibromyalgia; Hyperalgesia; Chronic Pain; Depression

Interventions

Electroacupuncture; Nutritional Status; Dietary Supplements

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics; Food; Food and Beverages

Central Study Contacts

Vasileia Nyktari

CONTACT

+302810392994; vnyktari@gmaill.com

Papaioannou

CONTACT

+302810392994

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: May 2, 2022
• Study Start: May 31, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 26, 2022

Record last verified: 2022-10

Locations

GR (1)