Neuroimaging Approaches to Deconstructing Acupuncture for Chronic Pain

Fibromyalgia Clinical Trial

Official title: Neuroimaging Approaches to Deconstructing Acupuncture for Chronic Pain

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Chronic Pain
• Fibromyalgia
• Myofascial Pain Syndromes

• NCT number: NCT02064296
• Study type: Interventional
• Source: University of Michigan
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Completion date: November 22, 2019