Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Chronic Pain
  • Pelvic Pain
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Factorial AssignmentIntervention Model Description: A single blind, randomized control, exploratory trial to assess the acute effects of tDCS and guided imagery in women with chronic pelvic pain. Qualified individuals will be randomized 1:1:1:1 to receive 1 session of one of the following treatments: 20 minutes of active tDCS with 25 minutes of guided imagery 20 minutes of active tDCS with no guided imagery 20 minutes of sham tDCS with 25 minutes of guided imagery 20 minutes of sham tDCS with no guided imagery Masking: Single (Participant)Masking Description: Device settingsPrimary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 64 years
Gender
Only males

Description

Chronic Pelvic Pain (CPP) is a common and often debilitating problem among women. CPP is pain that is felt below the belly button and is severe enough to cause feelings of pressure, pain while sitting or standing for long periods of time, pain with intercourse, painful urination, and pain with bowel...

Chronic Pelvic Pain (CPP) is a common and often debilitating problem among women. CPP is pain that is felt below the belly button and is severe enough to cause feelings of pressure, pain while sitting or standing for long periods of time, pain with intercourse, painful urination, and pain with bowel movements. Transcranial Direct Current Simulation (tDCS) is a non-invasive brain stimulation technique. As tDCS modulates nerve activity and connectivity, it is also expected to cause measurable changes in brain activity. Guided imagery is a form of hypnosis using words to direct one's thoughts and attention to imagined sensations. Guided imagery has demonstrated efficacy in reducing pain related to many conditions including cancer pain, chronic lower back pain, and post-operative pain. More information is needed to evaluate the effects of tDCS and guided imagery in the treatment of chronic pelvic pain. The study will consist of one visit. After informed consent is obtained, the following will be collected/completed: health history, demographics, vitals, and questionnaires (BDI, CAGE-AID, PCS, and VAS for pelvic pain). A urinalysis will be collected to assess for infection and a urine pregnancy test for women of child bearing potential. If a subject qualifies they will be randomized. Before treatment, subjects complete an EEG. Treatment will be delivered based on randomization group assignment. After treatment an EEG, VAS, GRA will be collected. Study staff will assess for adverse events during and after treatment.

Tracking Information

NCT #
NCT04250662
Collaborators
Not Provided
Investigators
Principal Investigator: Kenneth M Peters, MD Beaumont Health