Fibromyalgia
Conditions
Keywords
Fibromyalgia, Duloxetine, Cymbalta, Pain, Peripheral Nerve, Biopsy, Predictive
Brief summary
Subjects with Fibromyalgia who respond to Duloxetine have specific nerve fiber characteristics. This can be used to predict which future patients will respond to Duloxetine.
Detailed description
Subjects will have skin biopsies taken and evaluated for specific pathologies. All subjects will undergo a treatment period with Duloxetine. The analysis will correlate treatment effectiveness with pathological skin biopsy findings to predict future treatment success.
Interventions
DRUGDuloxetine
oral tablet, 30mg daily for 1 week (titration up) oral tablet, 60mg daily for 8 weeks (treatment) oral tablet, 30mg daily for 1 week (titration down, if needed)
Sponsors
University of California, San Diego
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Treatment Arm * Fibromyalgia Diagnosis * Female * Over the age of 18, under the age of 70 * Understands English * Not Pregnant/planning to become pregnant
Exclusion criteria
* No major psychiatric disorders * No major unconrolled systemic diseases which may require hospitalization in the next 6 months * Pregnant Inclusion Criteria: Control Arm * Female * Over the age of 18, under the age of 70 * Understands English * Not Pregnant/planning to become pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Reduction | 12 weeks | Changes in Pain measured by Numeric Pain Rating Scale over time. The Numeric Pain Rating Scale (NPRS) is assessing the patients pain on a 11-point rating scale from 0 - 10 with 0 being no pain at all and 10 being the worst imaginable pain. The test is self-reported and can also be administered by an interviewer. |
Countries
United States
Outcome results
None listed