Empowered Relief for Chronic Pelvic Pain (ER_for_CPP)

The University of Chicago

Status: Begins enrollment this month

Conditions: Chronic Pelvic Pain

Treatments: Behavioral: Empowered Relief (ER) Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07812857

IRB25-0652

Details and patient eligibility

About

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).

Full 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).

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Usual care.

No Intervention group

Description:

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 group

Description:

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

Treatment:

Behavioral: Empowered Relief (ER) Therapy