Brain Mechanisms of Psychosocial Aspects of Acupuncture Therapy

NCT02908022 | Completed

• 2 other identifiers: 2013P0023164R33AT009306-03
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief Summary

The overall aim of the present proposal is to investigate how patients' and clinicians' (Licensed acupuncturists, LAc) neural and autonomic processes during treatment interaction correlate to patient outcomes. Male and female healthy clinicians and fibromyalgia patients will be recruited for the study.

Conditions

Physician-patient Relationship; Fibromyalgia; Acupuncture Therapy

Outcome Measures

Primary Outcomes (1)

• Magnitude of patient/clinician concordance in brain activation of mirror brain circuitry during electroacupuncture therapy

  Patient/clinician concordance in brain activation will be assessed by functional Magnetic Resonance Imaging, simultaneously for both the patient and the clinician

  Up to 60 months

Secondary Outcomes (1)

• Correlation between patient/clinician brain activity concordance and pain relief from electroacupuncture therapy

  Up to 60 months

Study Arms (3)

Interaction

EXPERIMENTAL

Phase 1: Prior to the MRI sessions, the clinician will be introduced to the patient and do a general intake of physical examination. During the MRI sessions, the patient will receive experimental pressure pain via the Hokanson Rapid Cuff Inflator and electroacupuncture analgesia to the leg for pain relief.

Device: Electroacupuncture Analgesia; Device: Hokanson Rapid Cuff Inflator

No Interaction

EXPERIMENTAL

Phase 1: The clinician and the patient will first be introduced at the MRI sessions. During the MRI sessions, the patient will receive experimental pressure pain via the Hokanson Rapid Cuff Inflator and electroacupuncture analgesia to the leg for pain relief.

Device: Electroacupuncture Analgesia; Device: Hokanson Rapid Cuff Inflator

Longitudinal

EXPERIMENTAL

Phase 2: Prior to first MRI session, both clinician and patient will go through a training visit. During the first MRI session, the patient will receive experimental pressure pain to the left leg via Hokanson Rapid Cuff Inflator and electroacupuncture to the same leg for pain relief. Following the first MRI session, the patient will attend biweekly acupuncture treatment sessions with the clinician (6 treatments total). During the first session the clinician will be introduced to the patient and do a general intake in addition to the acupuncture treatment. The final MRI session will be identical to the first. The patient will receive experimental pressure pain via Hokanson Rapid Cuff Inflator and electroacupuncture to the same leg for pain relief.

Device: Electroacupuncture Analgesia; Device: Hokanson Rapid Cuff Inflator

Interventions

Electroacupuncture Analgesia DEVICE

For the MRI sessions, acupuncture needles will be inserted next to the cuff placed on the left leg and will be connected to electrodes. Low-amplitude electrical current will be activated when a button is pressed via a handheld device, controlled by the acupuncturist, in order to reduce pain, acting as an analgesic. Additionally, electroacupuncture-induced analgesia will be used for the treatments. During the treatment sessions the acupuncturist will insert needles in several locations aimed to reduce the patient's fibromyalgia pain. Low-amplitude electrical current will be activated by the acupuncturist using the same electroacupuncture device as in the MRI machine.

Interaction; Longitudinal; No Interaction

Hokanson Rapid Cuff Inflator DEVICE

The Hokanson Rapid Cuff Inflator will be placed on the lower right leg of the subject and utilized for pain testing purposes according to the protocol. Ascending pressures will be administered using the cuff to elicit different pain intensities.

Interaction; Longitudinal; No Interaction

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and Female healthy clinicians
• years of age
• Ability to read and understand English; English can be a second language provided that the participant feels that he/she understand all the questions used in the assessment measures.
• Have a clinical diagnosis of fibromyalgia and meet the Wolfe et al 2011 research criteria for fibromyalgia for at least one year
• Are on stable doses of medication for 30 days prior to entering the study and agree not to change medications or dosages during the trial
• to 60 years of age
• Right-handed
• Ability to read and understand English; English can be a second language provided that the participant feels that he/she understand all the questions used in the assessment measures

You may not qualify if:

• Any longer period of work experience involving pain treatment, pain rehabilitation etc. This is in order to exclude participants with biased expectations regarding different methods of analgesia
• Presence of any illness or medication use that is judged to interfere with the trial. For example: psychiatric disorder according to the DSM-IV manual, medication that can influence cognition or emotional processing, i.e. sleep medication, antidepressants, anti-convulsants or opioids
• Presence of any contraindications to fMRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy
• Inability to respond accurately to the pain-relieving intervention in the behavioral part of the experiment, indicating a lack of response to the expectancy manipulation. If the healthy volunteer or clinician is not a responder to the behavioral expectancy induction he or she will be excluded
• Unwillingness to receive brief experimental pain
• Leg pain or health issues that may interfere with the study procedures
• Comorbid acute pain condition
• Comorbid chronic pain condition that is rated by the subject as more painful than fibromyalgia
• Current use of opioid analgesics or stimulant medications or the fatigue associated with sleep apnea or shift work (e.g., modafinil)
• Documented peripheral neuropathy
• Any psychiatric disorder involving a history of psychosis (e. g schizophrenia, bipolar disorder, severe personality disorders)
• History of anxiety disorders or significant anxiety symptoms interfering with fMRI procedures (e.g., panic)
• Psychiatric hospitalization in the past 6 months
• Any impairment, activity or situation that in the judgment of the Study Coordinator or Principal Investigator would prevent satisfactory completion of the study protocol.
• Is an actual clinical patient of the clinician subject

Sponsors & Collaborators

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

Study Sites (2)

Martinos Center for Biomedical Imaging

Charlestown, Massachusetts, 02129, United States

Location

Spaulding Rehabilitation Hospital

Charlestown, Massachusetts, 02129, United States

Location

Related Publications (7)

• Schliessbach J, van der Klift E, Arendt-Nielsen L, Curatolo M, Streitberger K. The effect of brief electrical and manual acupuncture stimulation on mechanical experimental pain. Pain Med. 2011 Feb;12(2):268-75. doi: 10.1111/j.1526-4637.2010.01051.x. Epub 2011 Jan 28.

  PMID: 21276188 BACKGROUND

• Lang PM, Stoer J, Schober GM, Audette JF, Irnich D. Bilateral acupuncture analgesia observed by quantitative sensory testing in healthy volunteers. Anesth Analg. 2010 May 1;110(5):1448-56. doi: 10.1213/ANE.0b013e3181d3e7ef. Epub 2010 Mar 17.

  PMID: 20237044 BACKGROUND

• Zheng Z, Feng SJ, Costa Cd, Li CG, Lu D, Xue CC. Acupuncture analgesia for temporal summation of experimental pain: a randomised controlled study. Eur J Pain. 2010 Aug;14(7):725-31. doi: 10.1016/j.ejpain.2009.11.006. Epub 2009 Dec 31.

  PMID: 20045360 BACKGROUND

• Cruz-Almeida Y, Fillingim RB. Can quantitative sensory testing move us closer to mechanism-based pain management? Pain Med. 2014 Jan;15(1):61-72. doi: 10.1111/pme.12230. Epub 2013 Sep 6.

  PMID: 24010588 BACKGROUND

• Naeser MA, Hahn KA, Lieberman BE, Branco KF. Carpal tunnel syndrome pain treated with low-level laser and microamperes transcutaneous electric nerve stimulation: A controlled study. Arch Phys Med Rehabil. 2002 Jul;83(7):978-88. doi: 10.1053/apmr.2002.33096.

  PMID: 12098159 BACKGROUND

• Gabriel A, Sobota R, Gialich S, Maxwell GP. The use of Targeted MicroCurrent Therapy in postoperative pain management. Plast Surg Nurs. 2013 Jan-Mar;33(1):6-8; quiz 9-10. doi: 10.1097/PSN.0b013e3182844219.

  PMID: 23446501 BACKGROUND

• Gossrau G, Wahner M, Kuschke M, Konrad B, Reichmann H, Wiedemann B, Sabatowski R. Microcurrent transcutaneous electric nerve stimulation in painful diabetic neuropathy: a randomized placebo-controlled study. Pain Med. 2011 Jun;12(6):953-60. doi: 10.1111/j.1526-4637.2011.01140.x. Epub 2011 May 31.

  PMID: 21627767 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

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

Study Officials

• Vitaly Napadow, PhD, LicAc

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Harvard Medical School; Director, Center for Integrative Pain NeuroImaging (CiPNI)

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 20, 2016
• Study Start: September 1, 2016
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: October 16, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)