Online Pain Education for Inflammatory Bowel Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two online programs designed to help individuals with inflammatory bowel disease (IBD) manage chronic pain. The programs are called Empowered Relief and Living Better with Chronic Pain. The researchers aim to determine if these programs can reduce pain and enhance quality of life over eight weeks. Suitable candidates include those with Crohn's disease or ulcerative colitis who have experienced chronic pain for at least three months. Participants must be stable on their current treatment and have access to an internet-enabled device for the programs and surveys. As an unphased trial, this study provides a unique opportunity to explore new methods for managing chronic pain and improving quality of life.
What prior data suggests that these online pain education programs are safe for patients with inflammatory bowel disease?
Research has shown that Empowered Relief, a non-drug therapy, is under study to help individuals with inflammatory bowel disease (IBD) manage pain. Although specific safety information for Empowered Relief is not available, non-drug treatments like this are generally considered safer than medications. They emphasize teaching and self-management techniques, which most people handle well.
The trial is in a "Not Applicable" phase, indicating that the treatment is likely safe enough to test without requiring detailed safety trials first. This phase often applies to studies examining behaviors, procedures, or educational programs rather than new drugs.
In summary, while specific safety data for Empowered Relief is lacking, its role as an educational program suggests it should be safe for most participants.12345Why are researchers excited about this trial?
Researchers are excited about the trial for "Online Pain Education for Inflammatory Bowel Disease" because it explores innovative methods to manage chronic pain associated with the condition. The "Empowered Relief" program is distinct because it provides a 2-hour live-online session that teaches pain management techniques, supplemented by a binaural audio relaxation app designed to promote calm through brainwave entrainment. This approach contrasts with traditional treatments like medication or in-person therapy by offering a convenient, online format that participants can access from home. Additionally, the "Living Better with Chronic Pain" arm gives participants access to an online educational video, providing a flexible and scalable pain management solution. Researchers are keen to see if these accessible digital methods can effectively reduce pain and improve quality of life for those with inflammatory bowel disease.
What evidence suggests that this trial's treatments could be effective for chronic pain in IBD?
Research has shown that self-management programs can help people with chronic pain feel better. The Empowered Relief program, one of the treatments studied in this trial, has shown promise in improving pain-related outcomes. A review of studies found that about 66% of similar programs led to improvements. These programs typically reduce the impact of pain on daily life, enhancing quality of life. Although limited data exists on Empowered Relief specifically for inflammatory bowel disease (IBD), similar methods have effectively managed chronic pain. Another treatment arm in this trial, Living Better with Chronic Pain, serves as a comparator to evaluate the effectiveness of the Empowered Relief program.23678
Who Is on the Research Team?
Christopher V Almario, MD, MSHPM
Principal Investigator
Cedars-Sinai Medical Center
Are You a Good Fit for This Trial?
This trial is for adults with Crohn's disease or ulcerative colitis (types of IBD) who are experiencing ongoing, chronic pain. Participants need to be able to use an online program and complete surveys over several weeks.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants attend a 2-hour online session and use a binaural audio app daily for 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment through weekly online surveys
What Are the Treatments Tested in This Trial?
Interventions
- Empowered Relief
- Living Better with Chronic Pain
Trial Overview
The study compares two different online pain education programs—'Living Better with Chronic Pain' and 'Empowered Relief.' Each takes about 2 hours to finish at home. The goal is to see which helps more with pain and quality of life.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants randomized to the Empowered Relief arm will be scheduled to attend a 2-hour, live-online group Empowered Relief session. Empowered Relief sessions will be conducted via Zoom. Attendance of the Empowered Relief session will be monitored by study staff throughout the 2-hour session. Following the Empowered Relief session, participants in this arm will be provided with access to the 20-minute binaural audio relaxation app the that accompanies the Empowered Relief program and promotes calm through brainwave entrainment. Participants will be instructed to utilize the binaural audio app daily for the 8-weeks following the completion of the Empowered Relief session.
Participants randomized to the Living Better with Chronic Pain arm will be sent a link to access the 2-hour, online recording. Completion of the entire Living Better with Chronic Pain video will be monitored and confirmed by study staff.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cedars-Sinai Medical Center
Lead Sponsor
Citations
Inflammatory Bowel Disease (IBD) Clinical Trials
The goal of this clinical trial is to learn whether IBD patients have better disease outcomes and feel more empowered to manage their condition
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facebook.com/ccfafb/posts/the-foundation-is-collaborating-with-sanofi-and-insight-economics-on-a-study-to-/1517429423756969/Crohn's & Colitis Foundation
The findings from the survey will help to better understand IBD so improvements can be made in the management of Crohn's disease and Ulcerative ...
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