Empowered Relief Therapy for Pelvic Pain

(ER_for_CPP Trial)

IP
SA
Overseen BySumeyra Agambayev, MS
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding Empowered Relief (ER) therapy to usual treatments helps alleviate chronic pelvic pain. Researchers aim to determine if this approach reduces the impact of pain on daily life and improves pain levels and quality of life. The study seeks women who have experienced pelvic pain for at least six months, affecting them at least one week each month. Participants must speak English and meet a certain pain level but should not be planning surgery soon. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future treatment options.

What prior data suggests that Empowered Relief Therapy is safe for patients with chronic pelvic pain?

A previous study found that Empowered Relief (ER) therapy was well-received by individuals with chronic pain, including chronic pelvic pain. Research has shown that ER therapy is safe for various types of chronic pain. Another study demonstrated that ER therapy offers benefits comparable to an eight-session cognitive behavioral therapy (CBT) program, a well-established treatment for chronic pain. This suggests that ER therapy is both effective and safe for participants. No significant evidence of major side effects or problems has been linked to Empowered Relief therapy. Overall, it appears to be a safe option for managing chronic pelvic pain.12345

Why are researchers excited about this trial?

Empowered Relief (ER) Therapy is unique because it offers a new approach to managing chronic pelvic pain by incorporating a virtual class designed to teach pain management techniques. Unlike the standard treatments that rely on medications or physical interventions like pelvic floor therapy and nerve block injections, ER Therapy empowers patients with self-management skills. Researchers are excited about this treatment because it could provide patients with long-term coping strategies and improve their quality of life, potentially reducing reliance on traditional medical interventions.

What evidence suggests that Empowered Relief Therapy is effective for chronic pelvic pain?

Research has shown that Empowered Relief (ER) Therapy effectively manages chronic pain. One study found that a single ER session provided pain relief comparable to an eight-session cognitive behavioral therapy (CBT) course, with effects lasting up to six months. This therapy teaches pain relief skills in a two-hour session, offering a quick and impactful option. It reduces the impact of pain on daily life, helping individuals manage pain more effectively day-to-day. Additionally, it has improved both pain levels and overall quality of life for those with chronic pain. In this trial, participants will receive either standard treatment for chronic pelvic pain or standard treatment combined with enrollment in an ER virtual class. These findings suggest that ER Therapy could be a promising addition to standard treatments for chronic pelvic pain.12467

Who Is on the Research Team?

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Kimberly Kenton, MD

Principal Investigator

University of Chicago, Urogynecology and Reconstructive Pelvic Surgery

Are You a Good Fit for This Trial?

This trial is for adults with chronic pelvic pain. Participants should be able to take part in therapy sessions and follow study instructions. People who cannot participate in group therapy or have conditions that would interfere with the study may not be eligible.

Inclusion Criteria

English fluency
I was assigned female at birth.
Participant is willing and able to provide written informed consent
See 3 more

Exclusion Criteria

Gross cognitive impairment
I am scheduled for surgery during the study or within a month after surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive standard treatment for chronic pelvic pain, which may include medications, pelvic floor physical therapy, and/or trigger point/nerve block injections. Participants randomized to the experimental group also attend an Empowered Relief session within 4 weeks.

12 weeks
Baseline and follow-up questionnaires at 2 and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up questionnaires assessing pain interference, pain intensity, and quality of life.

4 weeks
2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Empowered Relief (ER) Therapy

Trial Overview

The study compares standard treatment alone versus standard treatment plus Empowered Relief (ER) Therapy, a single-session pain management class, to see if adding ER helps reduce how much pain interferes with daily life.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Usual care with enrollment in an ER virtual class within four weeks of being approached with studyExperimental Treatment1 Intervention
Group II: Usual care.Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials
1,086
Recruited
844,000+

Citations

Empowered Relief, cognitive behavioral therapy, and health ...

A One-session empowered relief provides clinically meaningful effects comparable to an 8-session cognitive behavioral therapy at 6 months for ...

NCT07812857 | Empowered Relief for Chronic Pelvic Pain

The investigators hypothesize that patients will show improved pain interference at two-weeks post-baseline. patients receiving ER (Empowered ...

Empowered Relief for Chronic Pelvic Pain - ClinicalTrials.Veeva

The investigators hypothesize that patients will show improved pain interference at two-weeks post-baseline. In addition, the investigators ...

CBT vs. Empowered Relief for Chronic Pain

Studies suggest it provides meaningful pain relief and remains as effective as the longer CBT program six months after treatment, offering a promising

protocol for the national PROGRESS study | Pain Medicine

A 1-session pain relief skills class (Empowered Relief; ER) has shown efficacy for multidimensional symptom reduction in various homogenous pain populations.

Comparative Effectiveness of Online 8-session CBT vs. 1- ...

The purpose of this study is to conduct a pragmatic clinical trial comparing the effectiveness of: (1) 8-week cognitive behavioral therapy for chronic pain ...

Management - EAU Guidelines on Chronic Pelvic Pain

Mensendieck somatocognitive therapy showed a pain reduction after one year follow-up of 64%. Efficacy and safety of pelvic floor … 59% and 26%, respectively. ...