Brain Mechanisms of Psychosocial Aspects of Acupuncture Therapy

Launched by MASSACHUSETTS GENERAL HOSPITAL · Sep 16, 2016

Keywords

ClinConnect Summary

This clinical trial is exploring how the interaction between patients with fibromyalgia and acupuncturists can affect treatment outcomes. The researchers want to understand how both the patients' and the acupuncturists' brain and body responses during acupuncture sessions are related to how well the patients feel afterward. To participate, healthy acupuncturists aged 25 to 60 and fibromyalgia patients aged 21 to 60 with a stable treatment plan may be eligible. However, certain health conditions or medications may exclude people from joining the study.

Participants can expect to engage in acupuncture therapy and undergo some assessments related to their pain and treatment responses. It's important to know that individuals with certain psychiatric conditions, recent hospitalizations, or significant anxiety may not qualify for the trial, as these factors could affect the study's outcomes. Overall, the trial aims to shed light on the connection between the treatment experience and patient results, which could help improve acupuncture therapy for fibromyalgia in the future.

Gender

ALL

Eligibility criteria

• Phase 1:
• Inclusion Criteria (Healthy Clinicians):
• • Male and Female healthy clinicians
• • 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.
• Inclusion Criteria (Fibromyalgia Patients):
• • 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
• Exclusion Criteria (All participants):
• • 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
• Exclusion Criteria (Specific to Fibromyalgia Patients):
• • 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:
• Inclusion Criteria (healthy individuals):
• • 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.
• Inclusion Criteria (FM patients):
• • 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 (all participants):
• • 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.
• Exclusion Criteria (specific to FM patients):
• • 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