Empowered Relief Class for Chronic Pain
(ER-Y Trial)
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Stanford University
Disqualifiers: Seizures, Cerebral palsy, Severe depression, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
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 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.
12345What 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.
26789Eligibility Criteria
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.
I am between 10 and 18 years old.
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.
Trial Timeline
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Empowered Relief for YouthExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Stanford UniversityPalo Alto, CA
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Who Is Running the Clinical Trial?
Stanford UniversityLead Sponsor
References
Parents' perspective of their journey caring for a child with chronic neuropathic pain. [2019]When a child has chronic pain, it affects the parents. Their response and how it is factored into their lives and family function was the phenomenon of interest that drove this study. The available literature was sparse, especially when the pain etiology was neuropathic. The purpose of this study was to describe the parents' perception of the pain journey from the initial occurrence of their child's pain through the labyrinth of treatment options to successful outcome, to gain a better understanding of parental beliefs about pain, and to learn how parental attitudes and behaviors relate to children's response to treatment for chronic pain. Qualitative descriptive design was used to better understand the phenomenon from those who were the experts because they had experienced it. Parents whose child was enrolled in a pain rehabilitation program participated in open-ended interviews. The children/adolescents were 8-18 years old and diagnosed with complex regional pain syndrome or a related chronic pain condition. During data immersion, the investigators uncovered the pervasive underlying themes of suffering and disempowerment. In addition, the multiple meaning elements were grouped into three categories and supportive subcategories labeled as follows: parent distress, with subcategories schism in parenting, searching, and disabled parenting; and lack of control, with the subcategories family/community, fear, and empowerment. The voices of parents were heard in their description of the exhausting and difficult journey in search of pain relief for their child. Their comments provided insight into how they defined the child's pain and their related parental role.
Multidisciplinary Treatment for Adolescents with Chronic Pain and/or Fatigue: Who Will Benefit? [2018]The aims of this study were, first, to determine the percentage of adolescents with chronic pain/fatigue successfully treated with rehabilitation treatment for chronic pain/fatigue and, second, to identify predictors for a successful rehabilitation treatment.
Maintaining lasting improvements: one-year follow-up of children with severe chronic pain undergoing multimodal inpatient treatment. [2022]To investigate the long-term effectiveness of a 3-week multimodal inpatient program for children and adolescents with chronic pain.
Enhancing Exposure Treatment for Youths With Chronic Pain: Co-design and Qualitative Approach. [2023]Increasing the access to and improving the impact of pain treatments is of utmost importance, especially among youths with chronic pain. The engagement of patients as research partners (in contrast to research participants) provides valuable expertise to collaboratively improve treatment delivery.
Specialized Rehabilitation Programs for Children and Adolescents with Severe Disabling Chronic Pain: Indications, Treatment and Outcomes. [2022]Children and adolescents with highly disabling chronic pain of high intensity and frequency are admitted to specialized pain rehabilitation programs. Some barriers to obtaining this specialized care include a lack of availability of treatment centers, a perceived social stigma and individual barriers such as socioeconomic status. Specialized rehabilitation programs for severe disabling chronic pain worldwide have similarities regarding admission criteria, structure and therapeutic orientation. They differ, however, regarding their exclusion criteria and program descriptions. The short- and long-term effectiveness of some rehabilitation programs is well documented. All countries should promote the establishment of future pediatric pain centers to improve the health care of children and adolescents suffering from severe chronic pain. Standardized reporting guidelines should be developed to describe treatments and outcomes to enable comparability across treatment centers.
Pediatric pain management: the multidisciplinary approach. [2022]Chronic pain in children and adolescents is a growing problem and one that is increasingly being addressed with multidisciplinary treatment teams. This review summarizes different multidisciplinary clinics, focusing specifically on intensive pediatric pain rehabilitation centers. This review offers a summary of the challenges faced by these programs and areas for future study.
Yoga for youth in pain: the UCLA pediatric pain program model. [2021]Children, adolescents, and young adults do not typically feature in clinics, studies, and mainstream notions of chronic pain. Yet many young people experience debilitating pain for extended periods of time. Chronic pain in these formative years may be especially important to treat in order for young patients to maintain life tasks and to prevent protracted disability. The Pediatric Pain Program at the University of California, Los Angeles, is a multidisciplinary treatment program designed for young people with chronic pain and their families. We offer both conventional and complementary medicine to treat the whole individual. This article describes the work undertaken in the clinic and our newly developed Yoga for Youth Research Program. The clinical and research programs fill a critical need to provide service to youth with chronic pain and to scientifically study one of the more popular complementary treatments we offer, Iyengar yoga.
A randomized controlled trial of graded exposure treatment (GET living) for adolescents with chronic pain. [2023]Graded exposure treatment (GET) is a theory-driven pain treatment that aims to improve functioning by exposing patients to activities previously feared and avoided. Combining key elements of GET with acceptance-based exposure, GET Living (GL) was developed for adolescents with chronic pain (GL). Based on robust treatment effects observed in our single-case experimental design pilot trial of GL (NCT01974791), we conducted a 2-arm randomized clinical trial comparing GL with multidisciplinary pain management (MPM) comprised of cognitive behavioral therapy and physical therapy for pain management (NCT03699007). A cohort of 68 youth with chronic musculoskeletal pain (M age 14.2 years; 81% female) were randomized to GL or MPM. Owing to COVID-19 restrictions, 54% of participants received zoom video delivered care. Assessments were collected at baseline, discharge, as well as at 3-month and 6-month follow-up. Primary outcomes were self-reported pain-related fear and avoidance. Secondary outcomes were child functional disability and parent protective responses to child pain. As hypothesized, GL improved in primary and secondary outcomes at 3-month follow-up. Contrary to our superiority hypothesis, there was no significant difference between GL and MPM. Patients reported both GL and MPM (in person and video) as credible and were highly satisfied with the treatment experience. Next steps will involve examining the single-case experimental design data embedded in this trial to facilitate an understanding of individual differences in treatment responses (eg, when effects occurred, what processes changed during treatment within the treatment arm). The current findings support GET Living and MPM for youth with chronic pain.
Patient expectations for a multimodal pain rehabilitation programme: active participation and coping skills. A qualitative study. [2018]To describe what patients with chronic pain expect from a multimodal pain rehabilitation programme.