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

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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-session pain management class for youth focused on pain science education and teaching self-regulatory skills for pain management based on the evidence-based adult ER class. Feasibility and acceptability of ER-Y will be assessed post-class. Preliminary efficacy will be assessed by administering surveys at baseline, 4-weeks, 8-weeks, and 12-weeks post class.

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 makes the Empowered Relief for Youth treatment unique for chronic pain?

Empowered Relief for Youth is unique because it focuses on teaching coping skills and self-management strategies in a single-session class, which is different from traditional treatments that often involve multiple sessions and a combination of therapies like cognitive behavioral therapy and physical therapy. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Empowered Relief for Youth, Empowered Relief, ER-Y for chronic pain?

The research highlights the importance of specialized rehabilitation programs and multimodal treatments for children and adolescents with chronic pain, which have shown short- and long-term effectiveness. Although not directly about Empowered Relief, these findings suggest that structured, comprehensive approaches can be beneficial for managing chronic pain in young people. ^{2 6 7 8 9}

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

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Parents' perspective of their journey caring for a child with chronic neuropathic pain. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Multidisciplinary Treatment for Adolescents with Chronic Pain and/or Fatigue: Who Will Benefit? [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Maintaining lasting improvements: one-year follow-up of children with severe chronic pain undergoing multimodal inpatient treatment. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

Enhancing Exposure Treatment for Youths With Chronic Pain: Co-design and Qualitative Approach. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Specialized Rehabilitation Programs for Children and Adolescents with Severe Disabling Chronic Pain: Indications, Treatment and Outcomes. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Pediatric pain management: the multidisciplinary approach. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Yoga for youth in pain: the UCLA pediatric pain program model. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of graded exposure treatment (GET living) for adolescents with chronic pain. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Patient expectations for a multimodal pain rehabilitation programme: active participation and coping skills. A qualitative study. [2018]