Empowered Relief Class for Chronic Pain

(ER-Y Trial)

Overseen By Nicole Jehl, BS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Seizures, Cerebral palsy, Severe depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how a single-session pain management class, called Empowered Relief for Youth, can help young people understand and manage chronic pain. The class will teach pain science and self-regulation techniques to improve pain management. Researchers will assess the class's reception and initial effectiveness through surveys over three months. Children and teens aged 10 to 18 with chronic pain who speak English may be suitable for this trial. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative pain management strategies for youth.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this class is safe for youth with chronic pain?

Research has shown that the Empowered Relief class is a well-accepted method for managing chronic pain. One study found that a single session of Empowered Relief had effects similar to an 8-session cognitive behavioral therapy, even six months later. This suggests it can be both effective and manageable for participants.

In another study involving 172 teenagers with chronic pain or fatigue, nearly half experienced positive results after treatment. This underscores the potential benefits of this method for young people.

Empowered Relief does not involve medication or physical treatments, reducing the likelihood of side effects. Instead, it focuses on teaching participants about pain and self-management, making it a safe option for many. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Empowered Relief for Youth because it offers a fresh approach to managing chronic pain by focusing on education and self-regulation skills. Unlike traditional treatments that often rely on medication or ongoing therapy sessions, this is a single-session class that teaches pain science and self-management techniques. This innovative method empowers young individuals to understand and manage their pain independently, potentially reducing reliance on medications and enhancing their quality of life.

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

Studies have shown that Empowered Relief, a one-time class teaching pain management skills, works as well as an eight-session therapy program for reducing chronic low back pain. It reduces "pain catastrophizing," altering how much pain bothers individuals. This program also positively affects pain levels and sleep issues. In this trial, participants will receive the Empowered Relief for Youth class to determine if this approach can help young people manage chronic pain by educating them about pain and control strategies. While researchers are still collecting specific data for young people, the success in adults is promising. ^{1 2 6 7 8}

Who Is on the Research Team?

Laura Simons, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for English-speaking youths aged 10 to 18 who have been diagnosed with various types of chronic pain, including neuropathic pain and fibromyalgia. It's not suitable for those with neurological conditions like seizures or severe mental health issues such as intense depression or anxiety.

Inclusion Criteria

I have been diagnosed with chronic pain.

English speaking

Exclusion Criteria

I have been diagnosed with a neurological condition like seizures or cerebral palsy.

You have a serious mental health condition, like severe depression or anxiety, as noted in your medical records.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend a single-session pain management class focused on pain science education and self-regulatory skills

1 day

1 visit (in-person)

Follow-up

Participants are monitored for feasibility, acceptability, and preliminary efficacy through surveys

12 weeks

Surveys at baseline, 4 weeks, 8 weeks, and 12 weeks post class

What Are the Treatments Tested in This Trial?

Interventions

• Empowered Relief for Youth

Trial Overview The study tests a single-session class called Empowered Relief for Youth (ER-Y), which educates about pain science and teaches self-regulation skills for managing chronic pain. The program's feasibility and effectiveness will be evaluated over a period of up to 12 weeks post-class.

How Is the Trial Designed?

Group I: Empowered Relief for Youth Experimental Treatment 1 Intervention

Empowered Relief for Youth is a single-session pain management class focused on pain science education and teaching self-regulatory skills for pain management based on the evidence-based adult ER class.

Empowered Relief for Youth is already approved in United States for the following indications:

Approved in United States as Empowered Relief for:

• Chronic pain management in youth

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

Chronic pain in children and adolescents is becoming more common, leading to the development of multidisciplinary treatment teams to address this issue effectively.

The review highlights the challenges faced by intensive pediatric pain rehabilitation centers and suggests areas for future research to improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric pain management: the multidisciplinary approach. Odell, S., Logan, DE.[2022]

In a study of 172 adolescents with chronic pain/fatigue, nearly 50% experienced successful treatment outcomes, indicating that rehabilitation can be effective for this population.

Adolescents with higher levels of pain/fatigue and a passive coping style before treatment were more likely to show improvement, suggesting these factors can help predict treatment success, with boys benefiting more than girls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary Treatment for Adolescents with Chronic Pain and/or Fatigue: Who Will Benefit? Westendorp, T., Verbunt, JA., de Groot, IJM., et al.[2018]

Graded Exposure Living (GL) significantly improved pain-related fear and avoidance in adolescents with chronic musculoskeletal pain, showing positive outcomes at the 3-month follow-up in a randomized trial of 68 participants.

Both GL and Multidisciplinary Pain Management (MPM) were equally effective, with no significant differences in outcomes, indicating that both treatment approaches are credible and satisfactory for youth managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of graded exposure treatment (GET living) for adolescents with chronic pain. Simons, LE., Harrison, LE., Boothroyd, DB., et al.[2023]

Chronic pain is a significant issue for children, adolescents, and young adults, and addressing it is crucial for their overall well-being and to prevent long-term disability.

The Pediatric Pain Program at UCLA offers a multidisciplinary approach, combining conventional and complementary treatments, including a newly developed Yoga for Youth Research Program to study the effects of Iyengar yoga on managing chronic pain in young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga for youth in pain: the UCLA pediatric pain program model. Evans, S., Moieni, M., Sternlieb, B., et al.[2021]

A multidisciplinary exposure treatment for youths with chronic pain was found to help patients and caregivers process pain-related emotions and improve their relationships, highlighting its efficacy in emotional and relational aspects of pain management.

The study identified 12 key recommendations for improving pain treatment delivery, emphasizing the need for greater dissemination of exposure treatment, flexibility in its application, and empowering patients to engage in meaningful activities during their recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Exposure Treatment for Youths With Chronic Pain: Co-design and Qualitative Approach. Schemer, L., Hess, CW., Van Orden, AR., et al.[2023]

Children and adolescents with severe chronic pain often face barriers to accessing specialized rehabilitation programs, including limited availability of treatment centers and social stigma.

There is documented short- and long-term effectiveness of these rehabilitation programs, highlighting the need for all countries to establish pediatric pain centers and develop standardized reporting guidelines for treatments and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Specialized Rehabilitation Programs for Children and Adolescents with Severe Disabling Chronic Pain: Indications, Treatment and Outcomes. Stahlschmidt, L., Zernikow, B., Wager, J.[2022]

Patients with chronic pain expect to actively participate in a multimodal rehabilitation program and learn coping strategies to improve their daily lives, as revealed through qualitative interviews with 18 participants.

The study highlights the importance of addressing both positive and negative expectations about pain early in the rehabilitation process, emphasizing the need for interaction with healthcare professionals and fellow patients to enhance the effectiveness of the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient expectations for a multimodal pain rehabilitation programme: active participation and coping skills. A qualitative study. Larsson, B., Gard, G., Karlsson, L., et al.[2018]

Parents of children with chronic pain experience significant distress and feelings of disempowerment as they navigate the complex treatment journey, highlighting the emotional toll of their child's condition.

The study identified key themes in parental experiences, including distress related to parenting roles and a pervasive sense of lack of control, which can impact their child's response to pain treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parents' perspective of their journey caring for a child with chronic neuropathic pain. Gaughan, V., Logan, D., Sethna, N., et al.[2019]

A 3-week multimodal inpatient program for adolescents with chronic pain led to significant long-term improvements in pain-related disability, school absence, and emotional distress, with 56% of participants showing overall improvement after 1 year.

The study involved 167 adolescents and highlighted that those with higher emotional distress at the start may need additional support to sustain treatment benefits, indicating the importance of addressing emotional health in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maintaining lasting improvements: one-year follow-up of children with severe chronic pain undergoing multimodal inpatient treatment. Hirschfeld, G., Hechler, T., Dobe, M., et al.[2022]

Citations

1. stanfordhealthcare.org stanfordhealthcare.org/trials/e/NCT05998369.html

Empowered Relief for Youth Purpose. The purpose of this pilot study is to examine the feasibility and preliminary efficacy of Empowered Relief for Youth with chronic pain (ER-Y).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10824382/

Empowered Relief, cognitive behavioral therapy, and ... A One-session empowered relief provides clinically meaningful effects comparable to an 8-session cognitive behavioral therapy at 6 months for chronic low back ...

3. trials.arthritis.org trials.arthritis.org/trials/NCT05998369

Empowered Relief for Youth - Clinical Trial Finder The purpose of this pilot study is to examine the feasibility and preliminary efficacy of Empowered Relief for Youth with chronic pain (ER-Y). ER-Y is a single- ...

4. pcori.org pcori.org/research-results/2021/comparing-effectiveness-two-online-programs-treating-chronic-pain

Comparing the Effectiveness of Two Online Programs for ... The project compares the effectiveness of two different online programs for treating chronic pain. Who will this research inform?

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8463950/

Efficacy of a Single-Session “Empowered Relief” Zoom- ... The primary outcome was pain catastrophizing 1-month posttreatment, with pain intensity, pain bothersomeness, and sleep disruption as secondary outcomes. We ...

6. withpower.com withpower.com/trial/empowered-relief-class-for-chronic-pain-f5b49

Empowered Relief Class for Chronic Pain (ER-Y Trial) In a study of 172 adolescents with chronic pain/fatigue, nearly 50% experienced successful treatment outcomes, indicating that rehabilitation can be effective ...

7. clinicaltrials.stanford.edu clinicaltrials.stanford.edu/trials/e/NCT05998369.html

Empowered Relief for Youth - Clinical Trials | Stanford Medicine The purpose of this pilot study is to examine the feasibility and preliminary efficacy of Empowered Relief for Youth with chronic pain (ER-Y).

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11937707/

Zoom-Delivered Empowered Relief for Chronic Pain This study examined the impact of Zoom-delivered ER among people with chronic pain on long-term opioid therapy.