Chronic Pelvic PainER_for_CPPNCT07812857
Empowered Relief for Chronic Pelvic Pain
A study testing Empowered Relief (ER) Therapy in people with Chronic Pelvic Pain, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Chronic Pelvic Pain
- What is being tested?
- Empowered Relief (ER) Therapy
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients scheduled for surgery within the study period or within 1 month post-op
- Gross cognitive impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sumeyra Agambayev, MS contact
United States1 site
University of Chicago
Chicago, Illinois, 60637
Insiyyah Patanwala, MD, 773-702-6118, ipatanwala@bsd.uchicago.edu
Sumeyra Agambayev, MS, sumeyra.agambayev@bsd.uchicago.edu
About this study
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.
Read more
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
- 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.
- The investigators hypothesize that patients with the addition of ER to standard treatment will show greater improvement in pain intensity scores.
- To compare health related quality of life scores with the addition of empowered relief therapy to standard treatment in patients with chronic pelvic pain.
- 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).
- Conditions
- Chronic Pelvic Pain
- Being tested
- Empowered Relief (ER) Therapy
- Keywords
- chronic pelvic pain, empowered relief therapy, pain interference, cognitive behavior therapy, Gynecology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowered Relief (ER) TherapyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Empowered Relief (ER) Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- 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.
Measured: 12 weeks
Secondary outcomes (5)
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.
Measured: 12 weeks
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)
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pelvic PainStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kimberly Kenton, MD, Study chair, University of Chicago, Urogynecology and Reconstructive Pelvic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812857
- Sponsor's protocol ID
- IRB25-0652
- Acronym
- ER_for_CPP
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowered Relief for Chronic Pelvic Pain
- ClinicalTrials.gov ID
- NCT07812857
- Acronym / sponsor ID
- ER_for_CPP / IRB25-0652
- Conditions
- Chronic Pelvic Pain
- Keywords
- chronic pelvic pain, empowered relief therapy, pain interference, cognitive behavior therapy, Gynecology
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- The investigators hypothesize that patients with the addition of ER to standard treatment will show greater improvement in pain intensity scores.
- To compare health related quality of life scores with the addition of empowered relief therapy to standard treatment in patients with chronic pelvic pain.
- The investigators hypothesize that patients with addition of ER to standard treatment will show greater improvement in quality of life (QOL).
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model 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
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Empowered Relief (ER) TherapyRandomized 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Patients scheduled for surgery within the study period or within 1 month post-op
- Gross cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empowered Relief (ER) TherapyThe 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 | Behavioural | Usual care with enrollment in an ER virtual class within four weeks of being approached with study |
Primary outcome
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
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.
5 secondary outcomes
Pain Catastrophization Scale (PCS)
Time frame: 12 weeks
Numeric Rating Scale (NRS)
Time frame: 12 weeks
36-Item Short Form Health Survey (SF-36)
Time frame: 12 weeks
Patient Health Questionnaire-8 (PHQ-8)
Time frame: 12 weeks
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sumeyra Agambayev, MS contact
Kimberly Kenton, MD study chair
University of Chicago, Urogynecology and Reconstructive Pelvic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empowered Relief (ER) Therapy in people with Chronic Pelvic Pain, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Insiyyah Patanwala, MD ((773) 702-6118, ipatanwala@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.