Clinical trial NCT03594916: Efficacy of Transcranial Direct Current Stimulation for Severe Primary Dysmenorrhea
Official title: Efficacy of Transcranial Direct Current Stimulation for Severe Refractory Primary Dysmenorrhea: Translational and Genetic Neuroimaging Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Dysmenorrhea
Keywords: Dysmenorrhea
Neuromodulation
Transcranial direct current stimulation
Neuroimaging
Neuroplasticity
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2018-07-20
Enrollment: 31
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: active, sham
Primary purpose: TREATMENT

Brief summary: Primary Dysmenorrhea (PDM), defined as menstrual pain without discernable organic causes, is inexorably common in adolescent women, about 40-90% of women may suffer from it, and 20% of them can be severe in the context of being refractory to medication, daily function impairment, and having pain of severe degree. Novel therapeutic method is in need for pain alleviation for this particular phenotype. We have previously reported that PDM females may engage motor-cortex based descending pain modulation system in our resting-state functional Magnetic Resonance Imaging (rs-fMRI) and thermal pain-activation fMRI studies. Based on the reported analgesic efficacy of transcranial Direct Current Stimulation (tDCS) on the motor cortex for various experimental painful conditions and clinical pain disorders, we reason that tDCS can be effective for the severe and medication-refractory PDM patients. This study aim to investigate the analgesic efficacy of tDCS in severe PDMs and to elucidate the dynamic brain neuroplasticity in the context of functional connectivity (FC) of pain matrix after tDCS intervention. We will recruit 30 severe PDMs and randomly allocate them to either real or sham group in a triple-blind manner. rs-fMRI for functional connectivity analysis will be performed before and after the tDCS intervention. The imaging data will be correlated with behavioral and psychological measurements. This is the first study in the literature investigating the tDCS efficacy for severe PDM. The result can promise a new possibility for clinical application.


Eligibility criteria: Inclusion Criteria:

* 20-35 years old PDM patients
* Right-handedness
* A regular menstrual cycle: 27-32 days
* Cramping pain during the menstrual period in the last 6 months , VAS ≧ 7
* Abstinence for daily activities due to PDM
* Need analgesic or Physical therapy despite of no prominent effect

Exclusion Criteria:

* History of head injury
* Pathological pituitary gland disease
* Organic pelvic disease, psychiatric disorder
* Pregnancy, childbirth
* A metal or pacemaker implant.
* Take hormone agents within 6 months

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: change from baseline (1st menstrual phase, before tDCS) at one month (2nd menstrual phase, with tDCS), change from baseline (1st menstrual phase, before tDCS) at two months (3rd menstrual phase)
measure: Functional connectivity of rs-fMRI Imaging
timeFrame: change from baseline (before tDCS, before 2nd menstrual phase) at one week (after tDCS completion), change from baseline (before tDCS, before 2nd menstrual phase) at four weeks (before the 3rd menstrual phase)
Secondary outcomes:
measure: Quantitative sensory testing (QST)
timeFrame: change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)
measure: Spielberger State-Trait Anxiety Inventory (STAI)
timeFrame: change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)
measure: Beck Anxiety Inventory (BAI)
timeFrame: change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)
measure: Beck Depression Inventory (BDI)
timeFrame: change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)
measure: Pain Catastrophizing Scale (PCS)
timeFrame: change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)
measure: Long-form McGill Pain Questionnaire (MPQ)
timeFrame: change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)
measure: Short-Form Health Survey (SF-36)
timeFrame: change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at five weeks (after the 3rd menstrual phase)
measure: Blood Hormones Measurement
timeFrame: change from baseline (before tDCS) at one week (after tDCS completion), change from baseline (before tDCS) at four weeks (before the 3rd menstrual phase)
measure: Genotyping
timeFrame: baseline
measure: Efficacy of tDCS blinding
timeFrame: At 1 months after tDCS intervention
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References: