Clinical trial NCT02064296: Neuroimaging Approaches to Deconstructing Acupuncture for Chronic Pain
Official title: Neuroimaging Approaches to Deconstructing Acupuncture for Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia Chronic Pain
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: Massachusetts General Hospital
First posted: 2014-02-17
Enrollment: 121
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria for Fibromyalgia Participants

* 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.
* Pain greater than a certain threshold on the Visual Analog Scale (VAS) for pain; 7-day recall; \[Note: The VAS is widely used in clinical pain research and as such we chose to use it for inclusion criteria and for clinical pain assessment below. Within our group numerical ratings scales 0-100 are more commonly used in quantitative sensory assessment, and as such we chose to use NRS scales for evoked pain assessments below.\]
* 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.

Inclusion Criteria for Healthy Control Participants

* 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.

Exclusion Criteria for Fibromyalgia Participants:

* 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.
* Any impairment, activity or situation that in the judgment of the Study Coordinator or Principal Investigator that would prevent satisfactory completion of the study protocol.
* Contraindications to the Electrostimulator device: Participants with electrical implants (i.e. pacemakers, defibrillators), cardiac rhythmic disorders, seizure disorders, any skin disorder in the vicinity of the electrode or an malignant diseases in the region of application. (Fibromyalgia participants only)

Exclusion Criteria for Healthy Control Participants:

* Have a diagnosis of fibromyalgia or meet the Wolfe et al 2011 criteria for Fibromyalgia.
* Presence of a concurrent autoimmune or inflammatory disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, etc. that causes pain.
* 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.
* 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.
* Severe psychiatric illnesses (current schizophrenia, major depression with suicidal ideation, substance abuse within two years).
* Contraindications to fcMRI, fMRI, or 1H-MRS methods. (see above section)
* 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.
* Any impairment, activity or situation that in the judgment of the Study Coordinator or Principal Investigator that would prevent satisfactory completion of the study protocol.

Primary outcomes:
measure: Brain Neurocircuitry Underlying Chronic Pain (Percent of Time of a Somato-sensory Cortex Coactivation Pattern)
timeFrame: At baseline
measure: Change in Brain Connectivity With Acupuncture Treatment
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Change in Brain Neurochemistry of Combined Glutamate and Glutamine (Glx) Within the Anterior Insular Cortex With Acupuncture Treatment
timeFrame: Baseline and 4 weeks
measure: Change in Brain Neurochemistry of Gama-aminobutyric Acid (GABA) Within the Anterior Insular Cortex With Acupuncture Treatment
timeFrame: Baseline and 4 weeks
Other outcomes:
measure: Predicting Response to Acupuncture Using Brain Neurochemistry
timeFrame: Baseline
measure: Predicting Response to Acupuncture Using Brain Connectivity
timeFrame: Baseline
Locations:
city: Ann Arbor
country: United States
facility: Chronic Pain and Fatigue Research Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Richard E Harris, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Viataly Napadow, PhD
role: PRINCIPAL_INVESTIGATOR
References: