Empowered Relief Therapy for Pelvic Pain
(ER_for_CPP Trial)
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up questionnaires assessing pain interference, pain intensity, and quality of life.
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
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
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Chicago
Lead Sponsor
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. ...
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