Brain Mechanisms of Psychosocial Aspects of Acupuncture Therapy
NCT ID: NCT02908022
Last Updated: 2025-10-16
Study Results
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Basic Information
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COMPLETED
NA
180 participants
INTERVENTIONAL
2016-09-30
2024-05-31
Brief Summary
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Detailed Description
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Second phase: At training session both clinician and patient will fill out a set of questionnaires. During the first MRI session the clinician will receive painful stimulations with a pressure cuff on the leg over a 6-minute paradigm in order to get cerebral representation. The patient will then be placed in a different scanner running simultaneously and will experience pain stimulation with the pressure cuff while interacting via live camera with the clinician in the other scanner. When visually prompted via cues on a screen, the clinician will activate analgesia for the patient, through a response device (response box) in clinician's hand. Both patient and acupuncturist will be asked to give ratings of pain and other parameters during the scan. 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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Interaction
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.
Electroacupuncture Analgesia
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.
Hokanson Rapid Cuff Inflator
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.
No Interaction
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.
Electroacupuncture Analgesia
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.
Hokanson Rapid Cuff Inflator
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.
Longitudinal
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.
Electroacupuncture Analgesia
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.
Hokanson Rapid Cuff Inflator
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.
Interventions
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Electroacupuncture Analgesia
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.
Hokanson Rapid Cuff Inflator
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.
Eligibility Criteria
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Inclusion Criteria
* 25-60 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
* 21 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
1. Male and female healthy clinicians.
2. 25-65 years of age (clinicians)
3. 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.
1. Have a clinical diagnosis of fibromyalgia and meet the Wolfe et al 2011 research criteria for fibromyalgia for at least one year
2. 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
3. 21-65 years of age
4. 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.
Exclusion Criteria
* 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
Phase 2:
1. 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.
2. Presence of any illness that is judged to interfere with the trial. For example: psychiatric disorder according to the DSM-IV manual
3. Presence of any contraindications to fMRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.
4. 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 in-duction he or she will be excluded.
5. Unwillingness to receive brief experimental pain.
6. Leg pain or health issues that may interfere with the study procedures.
1. Comorbid acute pain condition
2. Comorbid chronic pain condition that is rated by the subject as more painful than fibromyalgia
3. Documented peripheral neuropathy
4. Any psychiatric disorder involving a history of psychosis (e. g schizophrenia, bipolar disorder, severe personality disorders)
5. History of anxiety disorders or significant anxiety symptoms interfering with fMRI procedures (e.g., panic)
6. Psychiatric hospitalization in the past 6 months
7. Marijuana use greater than once daily and unwillingness to withhold from consumption 12 hours prior to scans or lab visits
8. Unwillingness to withhold from consuming nicotine 4 hours prior to scans
9. Any impairment, activity or situation that in the judgment of the Study Coordinator or Principal Investigator would prevent satisfactory completion of the study protocol.
10. Is an actual clinical patient of the clinician subject
21 Years
65 Years
ALL
Yes
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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Vitaly Napadow, Ph.D., Lic.Ac.
Associate Professor, Harvard Medical School; Director, Center for Integrative Pain NeuroImaging (CiPNI)
Principal Investigators
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Vitaly Napadow, PhD, LicAc
Role: PRINCIPAL_INVESTIGATOR
Spaulding Rehabilitation Hospital
Locations
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Martinos Center for Biomedical Imaging
Charlestown, Massachusetts, United States
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2013P002316
Identifier Type: -
Identifier Source: org_study_id
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