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

ConditionsFibromyalgiaElectroacupunctureAcupunctureHyperalgesia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorUniversity of Crete

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patient's consent

Age >18 years old

Patients with diagnosed fibromyalgia from rheumatologists

Widespread pain more than 6 months

Disqualifiers

Deep depression

Biological agent use ( TNF inhibitors)

Heamatological diseases

Systemic Infections

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Electroacupuncture

    Other intervention

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

  • Nutrition

    Dietary supplement

    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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Electroacupuncture1 intervention
Group B: Electroacupuncture, Nutrition and Dietary supplement3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline
2

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.

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

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.

Time frame
End of 12th session of electroacupuncture - 6 weeks after baseline
4

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.

Time frame
6 months after the end of 12th session of electroacupuncture

Secondary outcomes

1

Pain estimation with Pressure algometer - baseline (trapezius)

Patients will undergo Pressure pain threshold estimation with a pressure algometer. Measurements will be taken at the trapezius muscle bilaterally and the mean value will be reported.

Time frame
baseline
2

Pain estimation with Pressure algometer - baseline (supraspinatus)

Patients will undergo Pressure pain threshold estimation with a pressure algometer. Measurements will be taken at the supraspinatus muscle bilaterally and the mean value will be reported.

Time frame
baseline
3

Pain estimation with Pressure algometer - baseline (tibia)

Patients will undergo Pressure pain threshold estimation with a pressure algometer. Measurements will be taken at the tibia bilaterally and the mean value will be reported.

Time frame
baseline
4

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

Patients will undergo Pressure pain threshold estimation with a pressure algometer. Measurements will be taken at the trapezius muscle bilaterally and the mean value will be reported.

Time frame
end of 3rd week of electroacupuncture

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Crete

Lead sponsor

University Hospital of Crete

Collaborator

Source ClinicalTrials.gov
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