Empowered Relief for Chronic Pelvic Pain

NCT07812857 | Not Yet Recruiting

• 1 other identifier: IRB25-0652
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.
2. 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.
3. 3.The investigators hypothesize that patients with addition of ER to standard treatment will show greater improvement in quality of life (QOL).

Conditions

Chronic Pelvic Pain

Keywords

chronic pelvic pain; empowered relief therapy; pain interference; cognitive behavior therapy; Gynecology

Outcome Measures

Primary Outcomes (1)

• 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

  1\. PROMIS pain interference scale score (an 8-item questionnaire which measures the extent to which pain hinders engagement with various life activities, including physical, cognitive, emotional, recreational, and social activities, as well as sleep and enjoyment of life). One represents never or normal functioning, and the higher number means always or more interference. The minimum raw score is 8 and the maximum raw score is 40.

  12 weeks

Secondary Outcomes (5)

• Pain Catastrophization Scale (PCS)

  12 weeks

• Numeric Rating Scale (NRS)

  12 weeks

• 36-Item Short Form Health Survey (SF-36)

  12 weeks

• Patient Health Questionnaire-8 (PHQ-8)

  12 weeks

• Generalized Anxiety Disorder-7 (GAD-7)

  12 weeks

Study Arms (2)

Usual care.

NO INTERVENTION

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

Usual care with enrollment in an ER virtual class within four weeks of being approached with study

EXPERIMENTAL

Randomized 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

Behavioral: Empowered Relief (ER) Therapy

Interventions

Empowered Relief (ER) Therapy BEHAVIORAL

The 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

Usual care with enrollment in an ER virtual class within four weeks of being approached with study

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients scheduled for surgery within the study period or within 1 month post-op
• Gross cognitive impairment

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Interventions

Therapeutics

Study Officials

• Kimberly Kenton, MD

  University of Chicago, Urogynecology and Reconstructive Pelvic Surgery

  STUDY CHAIR

Central Study Contacts

Insiyyah Patanwala, MD

CONTACT

(773) 702-6118; ipatanwala@bsd.uchicago.edu

Sumeyra Agambayev, MS

CONTACT

sumeyra.agambayev@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a pilot single site, randomized controlled clinical trial comparing the addition of empowered relief therapy to standard treatment alone in 100 women with chronic pelvic pain. Patients randomized to standard treatment alone will be offered to attend an empowered relief session after 12 weeks. if they are not satisfied with their symptom control

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 10, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)