Neuroimaging Approaches to Deconstructing Acupuncture for Chronic Pain

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Device: Needle acupuncture (Traditional Acupuncture); Device: Laser acupuncture (Non-traditional Acupuncture)

• Registration Number: NCT02064296
• Lead Sponsor: University of Michigan

Brief Summary

The aim of this study is to evaluate the impact of electro-acupuncture in pain processing on patients with fibromyalgia (FM). The investigators hypothesize that electro-acupuncture is effective for FM because it functions as a desensitization therapy, which when applied repeatedly over multiple treatment sessions, gradually habituates the nervous system to continuing pain and sensory signaling.

Detailed Description

This study design has two components: 1) a cross sectional assessment of brain chemistry, connectivity and response to pain in healthy controls and age- and sex-matched fibromyalgia patients, and 2) a longitudinal assessment of the same outcomes in fibromyalgia patients randomized to either electro-acupuncture (EA) or laser acupuncture.

The investigators will evaluate 80 fibromyalgia patients who will receive acupuncture treatment twice a week for 4 weeks, for a total of 8 treatments. Baseline data from these patients will be compared to results from 40 pain-free controls.

Participants will undergo experimental pain assessments as well as brain neuroimaging.

Note added after completion of study data gathering: Within the registration in ClinicalTrials.gov and the informed consent, one arm was referred to as "non-traditional acupuncture". In fact, this was a control arm, receiving mock laser acupuncture (Vita Laser 650, Lhasa OMS). They received 2 treatments per week for 4 weeks. As consented, they were told, with IRB permission, that they were receiving non-traditional laser acupuncture. This deception was essential to maintaining scientific integrity of the masking.

The laser acupuncture device (Vita Laser 650, Lhasa OMS) was positioned over all of the same acupoints used in electro-acupuncture (EA), but was turned off during treatment sessions. There was no palpation prior to positioning these devices, and there was no physical contact between device and skin.

Study Timeline

• Study First Submitted: 2014-02-11
• Study First Submitted QC: 2014-02-14
• Study First Posted: 2014-02-17
• Study Start: 2014-12
• Primary Completion: 2019-11-22
• Study Completion: 2019-11-22
• Disposition First Submitted: 2020-09-21
• Disposition First Submitted QC: 2020-09-21
• Disposition First Posted: 2020-09-28
• Results First Submitted: 2022-07-06
• Status Verified: 2022-08
• Results First Submitted QC: 2022-08-23
• Last Update Submitted: 2022-08-23
• Results First Posted: 2022-09-22
• Last Update Posted: 2022-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 121

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional Acupuncture	Needle acupuncture (Traditional Acupuncture)	40 fibromyalgia patients will be randomized to receive electro acupuncture (AS Super 4 digital needle stimulator, Harmony Medical Co) . They will receive 2 treatments per week for 4 weeks.
Non-Traditional Acupuncture	Laser acupuncture (Non-traditional Acupuncture)	40 fibromyalgia patients will be randomized to non-traditional laser acupuncture (Vita Laser 650, Lhasa OMS). They will receive 2 treatments per week for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Brain Connectivity With Acupuncture Treatment	Baseline and 4 weeks	Brain connectivity will be assessed at baseline and following either electro-acupuncture or mock laser acupuncture. Primary somatosensory cortex to insula connectivity. (Z-stat) A positive Z score reflects positive correlation in FMRI signal between different between brain areas. A negative Z score represents anti-correlation between in FMRI signal between brain regions. These scores reflect either positive connectivity or inhibitory connectivity. A mean of 0 represents no correlation or connectivity between regions.
Brain Neurocircuitry Underlying Chronic Pain (Percent of Time of a Somato-sensory Cortex Coactivation Pattern)	At baseline	Characterize the altered somatosensory-related neurocircuitry underlying chronic pain in FM, as shown by the difference in brain connectivity between healthy controls and FM patients as measured by FMRI (occurrence rate of co-activation pattern). For each arm, the coactivation pattern was assessed at rest and during a pressure pain stimulation.; This is measured by the percent of scan time that an individual's brain displayed a particular coactivation pattern related to the somatosensory system.

Secondary Outcome Measures

Name	Time	Method
Change in Brain Neurochemistry of Gama-aminobutyric Acid (GABA) Within the Anterior Insular Cortex With Acupuncture Treatment	Baseline and 4 weeks	Brain neurochemistry assessed at baseline and following either electro-acupuncture or mock laser acupuncture using proton magnetic resonance spectroscopy (1H-MRS) measures gama-aminobutyric acid (GABA).
Change in Brain Neurochemistry of Combined Glutamate and Glutamine (Glx) Within the Anterior Insular Cortex With Acupuncture Treatment	Baseline and 4 weeks	Brain neurochemistry assessed at baseline and following either electro-acupuncture or mock laser acupuncture using proton magnetic resonance spectroscopy (1H-MRS) measures of combined glutamate and glutamine (Glx).

Trial Locations

Locations (1)

Chronic Pain and Fatigue Research Center; 🇺🇸 Ann Arbor, Michigan, United States