ClinicalTrials.gg
Not yet recruitingNCT07812857ER_for_CPPUpdated Sep 14, 2026

Empowered Relief for Chronic Pelvic Pain

An interventional study of Empowered Relief (ER) Therapy in Chronic Pelvic Pain, sponsored by University of Chicago. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by University of Chicago · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 151 studies in Pelvic Pain with a site in United States — 36 open to participants now, 39 under way, 1 of them phase 3. Pelvic Pain · United States.

Planned enrollment
29th of 123
100 · median 50
Started
2026
with 13 others
No phase
71 of 151
22 open now
Primary completion
2027-10
later than 20 of 38 live
Registered
150th of 151
by date

Among the 151 studies in Pelvic Pain with a site in United States, this one is the 29th largest by planned enrollment of the 123 interventional ones, is one of 14 that started in 2026, is one of 71 with no phase, reaches primary completion later than 20 of the 38 other live ones, and was the 150th registered.

By phase

151 studies; the count open now beside each. This study's row is marked.

No phasethis study71 · 22 open
Observational28 · 9 open
Phase 222 · 0 open
Phase 413 · 2 open
Phase 39 · 1 open
Phase 17 · 2 open
Phase 1/21 · 0 open

By the year they started

First in 1998; this study’s year is marked. 14 started in 2026.

Size and results

Median enrollment 50 across the 123 interventional studies, 104 across the 28 observational. Of the 96 that completed or were terminated, 35 (36%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 151 studies in Pelvic Pain with a site in United States, or all of them as a file.
02

Study 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).
Read the detailed description

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. Patients presenting to the Gynecology Clinics at the UChicago Medicine will be approached for inclusion if they desire treatment for chronic pelvic pain and meet inclusion criteria.

Consenting participants will be randomized to referral to Empowered Relief session within 4 weeks in addition to their standard treatment or standard treatment alone. Both groups 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 both treatment groups. Both groups 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 (See Schedule of Measures).

03

Conditions studied

  • Chronic Pelvic Pain

Browse trials for

Keywords

  • chronic pelvic pain
  • empowered relief therapy
  • pain interference
  • cognitive behavior therapy
  • Gynecology
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participant is willing and able to provide written .
  • 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

Exclusion Criteria:

  • Patients scheduled for surgery within the study period or within 1 month post-op
  • Gross cognitive impairment
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
100 participants (estimated)

Study 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 study

    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

  • BehavioralEmpowered Relief (ER) Therapy

    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

06

What researchers measure

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.

    Time frame: 12 weeks

Secondary outcomes

  1. Pain Catastrophization Scale (PCS)

    Pain Catastrophization Scale (PCS) scor, a 13-item self-report questionnaire that measures the extent to which people experience catastrophic thoughts and feelings when experiencing pain. 13 statements rated on a 5-point Likert scale from 0 ("not at all") to 4 ("all the time") where higher scores reflect higher levels of catastrophic thinking.

    Time frame: 12 weeks

  2. Numeric Rating Scale (NRS)

    Numeric Rating Scale (NRS) pain scale score (a pain assessment tool that uses a 0-to-10 scale, where 0 represents "no pain" and 10 represents "the worst pain imaginable," to allow patients to self-report their pain intensity)

    Time frame: 12 weeks

  3. 36-Item Short Form Health Survey (SF-36)

    36-Item Short Form Health Survey (SF-36) QOL scale score (a 36-item, patient-reported survey used to measure health-related quality of life (HRQOL) across eight domains, providing summary scores for physical and mental health components). The higher scores indicate a better outcome or more favorable health state.

    Time frame: 12 weeks

  4. Patient Health Questionnaire-8 (PHQ-8)

    Patient Health Questionnaire-8 (PHQ-8) Depression index score (an 8-item self-reported measure used to assess depressive symptoms). Each item is rated from 0 to 3. The higher score means greater severity of depressive symptoms.

    Time frame: 12 weeks

  5. Generalized Anxiety Disorder-7 (GAD-7)

    Generalized Anxiety Disorder-7 (GAD-7) Anxiety index score (a brief, 7-item self-report questionnaire used to screen for and assess the severity of generalized anxiety disorder). Each of the seven items is scored from 0 to 3, with the total score ranging from 0 to 21. The higher score means increased severity of anxiety.

    Time frame: 12 weeks

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.

Of 110 non-industry interventional studies with no phase under Pelvic Pain, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's planned 12 months is below that.

Counting every sponsor, half of 114 studies reached it within 17 months; a quarter within 5 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2026
First posted
Sep 10, 2026
StartEst.
Oct 2026
Primary completionEst.
Oct 2027
CompletionEst.
Dec 2027
Last update
Sep 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07812857
Responsible party
Sponsor
First posted
Sep 10, 2026
Start date
Oct 2026 (estimated)
Primary completion
Oct 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Sep 14, 2026

Study contacts

Insiyyah Patanwala, MD
Contact
ipatanwala@bsd.uchicago.edu
(773) 702-6118
Sumeyra Agambayev, MS
Contact
sumeyra.agambayev@bsd.uchicago.edu
Kimberly Kenton, MD
study chair · University of Chicago, Urogynecology and Reconstructive Pelvic Surgery

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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