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NCT07812857
Empowered Relief for Chronic Pelvic Pain
Conditions: Chronic Pelvic Pain
Sex: Female
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: University of Chicago
Location: University of Chicago Chicago Illinois
Summary
Primary Aim
To determine if the addition of empowered relief therapy to standard treatment is superior to standard treatment alone in patients with chronic pelvic pain as measured by pain interference in patients with chronic pelvic pain.
The investigators hypothesize that patients will show improved pain interference at two-weeks post-baseline. In addition, the investigators hypothesize that patients receiving ER (Empowered Relief) will show a better trajectory of pain interference over time, relative to the control group.
Secondary Aims
1. To compare pain intensity scores (as measured by NRS-The Numerical Rating Scale pain) with the addition of empowered relief therapy to standard treatment in patients with chronic pelvic pain.
a. The investigators hypothesize that patients with the addition of ER to standard treatment will show greater improvement in pain intensity scores.
2. To compare health related quality of life scores with the addition of empowered relief therapy to standard treatment in patients with chronic pelvic pain.
1. The investigators hypothesize that patients with addition of ER to standard treatment will show greater improvement in quality of life (QOL).
Eligibility Criteria
Inclusion Criteria:
* Participant is willing and able to provide written informed consent.
* Has pelvic pain of at least 6 months in duration and at least 7 days per month; defined as pain in the abdomen below the level of the umbilicus, bladder pain, and/or vaginal pain.
* Female sex at birth
* Clinic pain intensity score of at least 4 (range, 0-10, with 10 indicating worst pain imaginable)
* English fluency
* Adults aged 18 to 70 years
Exclusion Criteria:
* Patients scheduled for surgery within the study period or within 1 month post-op
* Gross cognitive impairment
Source: ClinicalTrials.gov (NCT07812857). StuddyBuddy aggregates publicly available trial information.