Fibromyalgia Clinical Trial
Official title:
Effect of Repetitive Transcranial Direct Current Stimulation (tDCS) on Chronic Pelvic Pain
We will rigorously test whether modulation of the motor cortex by transcranial direct
current stimulation (tDCS) is an effective treatment for patients with chronic pelvic pain
through the following specific aims:
A) The primary aim of this study is to determine whether transcranial direct current
stimulation applied to the motor cortex in patients with chronic pelvic pain induces a
significant decrease in the pain or symptoms as compared with sham tDCS. We will also
measure changes in the clinical symptom scores of multiple pelvic organs, drug intake
(narcotic), anxiety, depression, traumatic stress, as well as overall improvement in the
quality of life to assess the effects of this treatment.
B) Determine the duration of the clinical effects of tDCS. We will therefore compare the
amelioration of pain and related symptoms between active and sham tDCS for one year
following treatment.
C) Determine whether tDCS changes the threshold for pain detection as compared with sham
tDCS. Patients with chronic pelvic pain have a lower threshold for pain as compared to
healthy subjects and we hypothesized that this threshold will increase after stimulation
with tDCS.
D) Finally, we will examine whether 5 days of tDCS treatment is safe for use in chronic
pelvic pain patients. Safety will be assessed through neuropsychological tests and adverse
event reporting.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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