Online Pain Education for Inflammatory Bowel Disease

ZK
SE
Overseen BySamuel Eberlein, MSHS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Cedars-Sinai Medical Center

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.12345

Why 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?

CV

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

I have a doctor-confirmed diagnosis of Crohn's disease or ulcerative colitis.
Access to an internet-enabled device for online surveys and intervention access
NIH PROMIS Pain Interference scale T-score ≥60
See 4 more

Exclusion Criteria

I have had CBT for chronic IBD-related pain.
I am currently taking opioid medications regularly.
I do not have cognitive or other issues that would prevent me from following the study plan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants attend a 2-hour online session and use a binaural audio app daily for 8 weeks

8 weeks
1 online session, daily app usage

Follow-up

Participants are monitored for safety and effectiveness after treatment through weekly online surveys

8 weeks
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

Group I: Empowered ReliefExperimental Treatment1 Intervention
Group II: Living Better with Chronic PainPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials
523
Recruited
165,000+

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

A Systematic Review of Self-Management Interventions ... - PMC

Improvements in an outcome were reported in 33 (66%) studies. Most of the interventions that significantly improved an outcome index were based on symptom ...

Online Pain Education for Crohn's Disease and Ulcerative ...

Clinical outcomes (pain intensity, pain interference, quality of life) will be assessed via online surveys at baseline and then weekly for 8- ...

Inflammatory Bowel Disease | Clinical

Study 108 interim data show 68% of UC patients remained in clinical remission at week 144 after de-escalating from 50 mg to 25 mg obefazimod daily. VIVID Post ...

A Comprehensive Self-Management Intervention for ...

Preliminary efficacy outcome variables include quality of life and symptoms. Outcomes data will be assessed at baseline, immediately post ...

Effectiveness and safety of non-pharmacological therapies for ...

The SUCRA plot (Figure 7A) indicated that APMX (95.9%) was the most effective non-pharmacological treatment for reducing disease activity in IBD ...

IBD RISE (RESILIENCE, INFORMATION, SUPPORT, AND ...

Effectiveness, Durability, and Safety of Ustekinumab in Inflammatory Bowel Disease: Results from the Taiwan Multicenter Real-world ...

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 ...