Empowered Relief for Chronic Pelvic Pain
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- University of Chicago
- Study ID
- NCT07812857
- Status
- Not Yet Recruiting
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Conditions
- Chronic Pelvic Pain
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Empowered Relief (ER) Therapy — BEHAVIORALThe Empowered Relief classes will be offered virtually via the Zoom platform every 2 weeks. Approved study personnel will contact patients to remind them of the upcoming ER group and to troubleshoot technological challenges. The certified ER leader uses a prepared, standardized PowerPoint presentation and lecture notes. Class involves didactic material about pain and strategies to manage it as well as experiential exercises including relaxation, reframing, and developing a pain coping toolbox. Participants are welcome to ask questions, but because time is limited, they will also be encouraged to pose questions in the chat box, stay after class, or contact the leader directly. The class is about 120 mins long and there are brief breaks at approximately 45 mins, 75 mins, and 105 mins. Nancy Beckman, PhD, is a clinical psychologist who specializes in chronic pain conditions and already runs ER sessions twice a month. She along with her trainees who are specializing in chronic pain and h
Study Details
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).
Key Dates
- First listed
- Sep 10, 2026
- Start date
- Oct 31, 2026
- Status verified
- Sep 2026
- Primary completion
- Oct 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- No Intervention: Usual care.The participants will receive standard treatment for chronic pelvic pain which may include medications (hormonal, muscle relaxants, neuromodulators, anti-depressants), pelvic floor physical therapy and/or trigger point/nerve block injections for pain relief. Specifics of standard treatment will be documented for and they will complete baseline questionnaires assessing pain interference, catastrophizing, pain intensity, and quality of life as well as follow up questionnaires at 2 weeks and 12 weeks after initiating standard therapy
- Experimental: Usual care with enrollment in an ER virtual class within four weeks of being approached with studyRandomized to referral to Empowered Relief session within 4 weeks in addition to their standard treatment or standard treatment alone. Theys will receive standard treatment for chronic pelvic pain which may include medications (hormonal, muscle relaxants, neuromodulators, anti-depressants), pelvic floor physical therapy and/or trigger point/nerve block injections for pain relief. Specifics of standard treatment will be documented and they will complete baseline questionnaires assessing pain interference, catastrophizing, pain intensity, and quality of life as well as follow up questionnaires at 2 weeks and 12 weeks after ER class or initiating standard therapy
Primary Outcome Measure
Determining if the addition of empowered relief therapy in addition 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 [ Time Frame: 12 weeks ]
Central Contacts
- Insiyyah Patanwala, MD(773) 702-6118
- Sumeyra Agambayev, MS
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | Sumeyra Agambayev, MS Insiyyah Patanwala, MD (PRINCIPAL_INVESTIGATOR) James Griffith, PhD (SUB_INVESTIGATOR) Nancy Beckman, PhD (SUB_INVESTIGATOR) |
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