Status:
TERMINATED
Analgesic Effect of Music Listening During Pain Elicitation in Fibromyalgia
Lead Sponsor:
University of Kansas Medical Center
Conditions:
Fibromyalgia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Patients with fibromyalgia (FM) are more sensitive to things that cause pain. Music lowers self-reported pain in patients with chronic pain. The investigators are able to measure pain sensitivity and ...
Detailed Description
Fibromyalgia can be thought of as a centralized pain state where pain is manifested and experienced in different body regions at different times. Individuals with centralized pain feel more pain than ...
Eligibility Criteria
Inclusion
- Ability to read and speak English to allow for written informed consent, phenotyping, and patient- reported outcomes measures
- Willingness to refrain from alcohol and nicotine on day of QST
- Willingness to refrain from physical activity or exercise that would cause muscle and/or joint soreness for 48 hours prior to testing (routine exercise or activity that does not lead to soreness is acceptable)
- The investigators will attempt to recruit individuals with no chronic daily use of adjunctive pain medications, including tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, and gabapentinoids as these drugs can influence QST findings, or have individuals be weaned off of these meds at least two weeks prior to being studied. If the investigators do need to allow individuals into these cohorts while on such medications because of pragmatic issues, this information will be recorded and patients will be asked to remain on a stable dose for at least two weeks prior to QST assessments.
Exclusion
- Individuals receiving or applying for compensation or disability and other aspects associated with potential secondary gain
- Inability to provide written informed consent
- Peripheral neuropathy or loss of sensation in the upper or lower extremities which would preclude QST testing
- Severe physical impairment (e.g., blindness, deafness, paraplegia)
- Co-morbid medical conditions that may significantly impair physical functional status (e.g., history of non- skin malignancy, or autoimmune disorder)
- Illicit drug or unreported opioid use (unreported opioid use would be considered opioid abuse and thereby excluded)
- Medical or psychiatric conditions that in the judgment of study personnel would preclude participation in this study (e.g., malignancy, psychosis, suicidal ideation)
- Pregnant or nursing
- Liver failure
- Self-reported liver cirrhosis
- Self-reported hepatitis
- Severe Cardiovascular disease (examples: history of myocardial infarction, unstable angina, severe coronary artery disease, congestive heart failure, or severe valvular abnormalities) that are self-reported by patient or by medical record
- Average daily opioid dosing of \>15 mg oral morphine equivalents preoperatively (e.g., \> two 5 mg oxycodone tablets/day or \> three 5 mg hydrocodone tablets/day). Conversions will be made based on well-accepted conversion tools used previously. The rationale to include some patients taking low dose opioids is to enhance the generalizability of the findings (opioids are common in patients with many pain states), while not causing confounding by including patients on very high doses of opioids which may be a cause of opioid induced hyperalgesia which closely resembles central sensitization
Key Trial Info
Start Date :
December 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04059042
Start Date
December 13 2019
End Date
March 23 2020
Last Update
December 15 2023
Active Locations (1)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160