Phase
Condition
Fibromyalgia
Treatment
Hokanson Rapid Cuff Inflator
Electroacupuncture Analgesia
Clinical Study ID
Ages 21-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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):
Male and female healthy clinicians.
25-65 years of age (clinicians)
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):
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
21-65 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.
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 that is judged to interfere with the trial. For example: psychiatric disorder according to the DSM-IV manual
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 in-duction 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 FM patients):
Comorbid acute pain condition
Comorbid chronic pain condition that is rated by the subject as more painful than fibromyalgia
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
Marijuana use greater than once daily and unwillingness to withhold from consumption 12 hours prior to scans or lab visits
Unwillingness to withhold from consuming nicotine 4 hours prior to scans
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
Study Design
Study Description
Connect with a study center
Martinos Center for Biomedical Imaging
Charlestown, Massachusetts 02129
United StatesActive - Recruiting
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts 02129
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.