Neuroimaging Approaches to Deconstructing Acupuncture for Chronic Pain

NCT02064296 | Completed Results DMC

• 2 other identifiers: AcuAfferenceR01AT007550
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia Chronic Pain

Outcome Measures

Primary Outcomes (2)

• Brain Neurocircuitry Underlying Chronic Pain (Percent of Time of a Somato-sensory Cortex Coactivation Pattern)

  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.

  At baseline

• Change in Brain Connectivity With Acupuncture Treatment

  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.

  Baseline and 4 weeks

Secondary Outcomes (2)

• Change in Brain Neurochemistry of Combined Glutamate and Glutamine (Glx) Within the Anterior Insular Cortex With Acupuncture Treatment

  Baseline and 4 weeks

• Change in Brain Neurochemistry of Gama-aminobutyric Acid (GABA) Within the Anterior Insular Cortex With Acupuncture Treatment

  Baseline and 4 weeks

Other Outcomes (2)

• Predicting Response to Acupuncture Using Brain Neurochemistry

  Baseline

• Predicting Response to Acupuncture Using Brain Connectivity

  Baseline

Study Arms (3)

Controls

NO INTERVENTION

Healthy pain free controls will be recruited for comparison with fibromyalgia patients.

Non-Traditional Acupuncture

ACTIVE COMPARATOR

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.

Device: Laser acupuncture (Non-traditional Acupuncture)

Traditional Acupuncture

ACTIVE COMPARATOR

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.

Device: Needle acupuncture (Traditional Acupuncture)

Interventions

Needle acupuncture (Traditional Acupuncture) DEVICE

This group will receive needle acupuncture at 3 pairs of sites. The needles will be stimulated with low intensity, low frequency electric current using a constant-current electro-acupuncture device (AS Super 4 digital needle stimulator).

Traditional Acupuncture

Laser acupuncture (Non-traditional Acupuncture) DEVICE

For non-traditional acupuncture, a laser acupuncture device (Vita Laser 650, Lhasa OMS) will be positioned over all of the same acupoints used in EA. There will be no palpation prior to positioning these devices, and there will be no physical contact between device and skin.

Non-Traditional Acupuncture

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have self-reported FM symptoms for at least one year and also meet the Wolfe et al 2011 criteria for Fibromyalgia.
• Continued presence of pain more than 50% of days.
• Willing to limit the introduction of any new medications or treatment modalities for control of FM symptoms during the study.
• Able to travel to the study site to receive acupuncture treatments up to two times weekly.
• Over 18 and under 65 years of age.
• Right-handed.
• Female.
• Capable of giving written informed consent.
• Over 18 and under 65 years of age.
• Female.
• Right-handed.
• Do not have fibromyalgia or an associated pain disorder, including: migraine, temporomandibular joint disorder (TMJ), chronic pelvic pain (CPP), or chronic fatigue syndrome (CFS).
• Pain less than a certain threshold on the Visual Analog Scale (VAS) for pain; 7-day recall
• Willing to complete all study procedures.
• Capable of giving written informed consent.

You may not qualify if:

• Acupuncture within last 6-months.
• Presence of a known coagulation abnormality, thrombocytopenia, or bleeding diathesis that may preclude the safe use of acupuncture.
• Presence of a concurrent autoimmune or inflammatory disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, etc., or any other chronic pain condition with pain greater than fibromyalgia pain.
• Peripheral neuropathy of know cause that interferes with activities of daily living.
• History of vascular surgery in lower limbs or current lower limb vascular dysfunction.
• History of head injury with substantial loss of consciousness.
• Routine daily use of narcotic analgesics, marijuana or have a history of substance abuse in the past 24 months as determine by subject self-report.
• Stimulant medications, such as those used to treat ADD/ADHD (e.g., amphetamine/ dextroamphetamine \[Adderall®\], methylphenidate, dextroamphetamine), or the fatigue associated with sleep apnea or shift work (e.g., modafinil), are excluded.
• Concurrent participation in other therapeutic trials.
• Pregnant or nursing.
• Severe psychiatric illnesses (current schizophrenia, major depression with suicidal ideation, substance abuse within two years).
• Contraindications to fcMRI, fMRI, or 1H-MRS methods. These may include but are not limited to: surgical clips, surgical staples, metal implants, and certain metallic dental material. \[Note: a more formal description of contraindications for MRI is present in our DSM Plan\].
• Use of over the counter pain medications (NSAIDs, etc.) on the day of MRI scan.
• Use of as needed narcotic pain medication 48 hours prior to MRI scan.
• Current, habitual, or previous use within the last 12 months of artificial nails, nail enhancements, or nail extensions that cover any portion of either thumbnail. Exceptions, including brief and/or occasional use, may be permissible at the discretion of the principle investigator.

Sponsors & Collaborators

• University of Michigan: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Massachusetts General Hospital: collaborator

Study Sites (1)

Chronic Pain and Fatigue Research Center

Ann Arbor, Michigan, 48106, United States

Location

Related Publications (1)

• Murphy AE, Buchtel H, Mawla I, Ichesco E, Larkin T, Harte SE, Zhan E, Napadow V, Harris RE. Temporal Summation but Not Expectations of Pain Relief Predict Response to Acupuncture Treatment in Fibromyalgia. J Pain. 2024 Oct;25(10):104622. doi: 10.1016/j.jpain.2024.104622. Epub 2024 Jul 8.

  PMID: 38986891 DERIVED

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Richard Harris
• Organization: University of Michigan

reharris@med.umich.edu

734-998-6996

Study Officials

• Richard E Harris, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Viataly Napadow, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 11, 2014
• First Posted: February 17, 2014
• Study Start: December 1, 2014
• Primary Completion: November 22, 2019
• Study Completion: November 22, 2019
• Last Updated: September 22, 2022
• Results First Posted: September 22, 2022

Record last verified: 2022-08

Locations

US (1)