Digital Pain Management Interventions for Chronic Pain and Opioid Use Disorder

Overseen By Paige Palenski, BA

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Stanford University

Must be taking: Opioids

Disqualifiers: Cognitive impairment, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Approximately 80 minutes

220 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it requires participants to have been using prescription opioids daily for at least 3 months, so it seems you may need to continue your current opioid medication.

What data supports the effectiveness of the treatment E-ROD, Empowered Relief, Empowered Relief: On-Demand, Health Education, Health Education, Cancer Health Education for chronic pain and opioid use disorder?

Research shows that interdisciplinary pain rehabilitation programs, which include elements like education and self-management, can effectively reduce pain and improve functioning in people with chronic pain, while also decreasing opioid use and misuse risk. ^{1 2 3 4 5}

Is the digital pain management intervention safe for humans?

The EMPOWER study, which includes digital pain management interventions, is designed to address safety concerns related to opioid tapering, aiming to prevent increased pain or distress. While specific safety data for the digital intervention itself is not detailed, the study's focus on safe opioid reduction suggests a careful approach to participant safety. ^{2 5 6 7 8}

What makes the E-ROD treatment unique for managing chronic pain and opioid use disorder?

E-ROD is a digital, web-based self-management intervention that empowers patients to manage their chronic pain and opioid use disorder through interactive online tools, making it more accessible and potentially more engaging than traditional treatments. Unlike standard pharmacological approaches, it focuses on behavioral strategies and patient empowerment, which can be particularly beneficial for those with opioid use disorder. ^{5 9 10 11 12}

What is the purpose of this trial?

The investigators will implement an international 2-arm online pragmatic feasibility randomized controlled trial (RCT) of a digital pain relief skills intervention "Empowered Relief: On-Demand" to reduce pain metrics, opioid craving, and opioid misuse. They will compare Empowered Relief to a no-skills digital health education ("Living Better") intervention in community-based individuals with comorbid chronic pain and prescription opioid misuse (N=220). Completion of the brief post-treatment survey is a binary measure of treatment engagement; treatment feasibility and appraisal are assessed with three items (satisfaction, perceived utility, and likelihood to use skills learned). Electronic surveys will measure opioid misuse behaviors, craving, and use; and pain intensity and psychological status at: baseline, immediately post-treatment; at post-treatment weeks 1 and 2; and months 1, 2, and 3.

Eligibility Criteria

This trial is for adults over 18 with chronic non-cancer pain lasting at least 6 months, who use prescription opioids daily and have misused them. Participants need internet access, an average pain intensity of ≥3, and must be fluent in English. Those with cognitive impairments or enrolled in another Empowered Relief study can't join.

Inclusion Criteria

I have been taking prescribed opioids daily for pain for at least 3 months.

Your average pain level is at least 3 on a pain scale.

I have had non-cancer pain for at least 6 months.

Exclusion Criteria

Inability to complete study electronic surveys

Cannot currently be enrolled in a study or trial with Empowered Relief as a treatment/intervention

I have significant memory or thinking problems.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Empowered Relief On-Demand intervention or the Living Better health education intervention

Approximately 80 minutes

Online intervention

Post-Treatment Assessment

Participants complete a brief post-treatment survey to assess treatment engagement and appraisal

Immediately post-treatment

Follow-up

Participants are monitored for opioid misuse behaviors, craving, pain intensity, and psychological status

3 months

Electronic surveys at weeks 1 and 2, and months 1, 2, and 3

Treatment Details

Interventions

• E-ROD
• Health Education

Trial Overview The trial tests 'Empowered Relief: On-Demand', a digital intervention aimed to reduce pain and opioid misuse against a health education program. It's a randomized controlled trial where participants are assigned to one of the two interventions by chance.

Participant Groups

Group I: Empowered Relief On Demand Experimental Treatment 1 Intervention

Empowered Relief On-Demand will include roughly 80 minutes of interactive and multimedia pain educational content that targets pain and stress self-regulation, pain medication misuse, a personalized plan for relief and an audio App for daily use.

Group II: Health Education (HE; "Living Better") Placebo Group 1 Intervention

The HE arm is an interactive digital general health education intervention called "Living Better" that is devoid of specific content on pain, psychological skills, and has no active strategies or worksheets.

E-ROD is already approved in United States, Canada, United Kingdom for the following indications:

Approved in United States as Empowered Relief for:

• Chronic pain
• Prescription opioid misuse
• Opioid use disorder

Approved in Canada as Empowered Relief for:

• Chronic pain
• Prescription opioid misuse
• Opioid use disorder

Approved in United Kingdom as Empowered Relief for:

• Chronic pain
• Prescription opioid misuse
• Opioid use disorder

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

The ePEEP program, a telehealth adaptation of the Patient Education Empowerment Programme for chronic pain, was found to be acceptable and feasible for participants, indicating its potential as a valuable resource for pain management during the COVID-19 pandemic.

Participants reported significant benefits from ePEEP, including personal development, relationship building, and enhanced learning about pain, suggesting that telehealth can effectively support chronic pain management and empower individuals in their health journeys.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"So, you must understand that that group changed everything": perspectives on a telehealth group intervention for individuals with chronic pain. Ernstzen, D., Keet, J., Louw, KA., et al.[2023]

The EMPOWER trial is a randomized controlled study involving approximately 400 chronic pain patients on long-term opioid therapy, aiming to evaluate the effectiveness of a web-based self-management program (E-Health) in reducing opioid use and pain levels.

Preliminary evidence suggests that the E-Health program can help decrease self-reported morphine equivalent dose (MED) while also alleviating pain, addressing the challenges of opioid dependency and limited access to non-drug therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design considerations for a remote randomized multi-site clinical trial evaluating an e-health self-management program for chronic pain patients receiving opioid therapy. Winhusen, T., Wilson, M., Dolor, RJ., et al.[2023]

Interdisciplinary pain rehabilitation programs (IPRPs) significantly improve both self-reported and performance-based functional outcomes in patients with chronic pain, regardless of whether they are using opioids or not, as shown in a study involving two cohorts over a 3-week treatment period.

The study found that improvements in function were evident immediately after treatment and persisted for at least 6 months, highlighting the effectiveness of IPRPs in helping patients discontinue opioid use while enhancing their physical and emotional well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal Treatment Outcomes for an Interdisciplinary Pain Rehabilitation Program: Comparisons of Subjective and Objective Outcomes on the Basis of Opioid Use Status. Gilliam, WP., Craner, JR., Cunningham, JL., et al.[2022]

An interdisciplinary pain rehabilitation program (PRP) significantly improved pain severity, functioning, psychological symptoms, and emotional quality of life in 60 patients with chronic pain, demonstrating its effectiveness as a treatment option.

The program also reduced opioid use from 58% of patients at the start to 15% at discharge, and decreased opioid misuse risk, as indicated by a drop in misuse scores from above to below the cutoff for risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain rehabilitation's dual power: Treatment for chronic pain and prevention of opioid-related risks. Crouch, TB., Wedin, S., Kilpatrick, RL., et al.[2021]

A pilot study involving 26 adults with opioid use disorder (OUD) showed that using the mobile app 'uMAT-R' significantly increased interest in treatment from 32% to 48%.

Participants also reported improved attitudes towards medication-assisted treatment (MAT), with 88% believing the app would be helpful in making recovery decisions, indicating its potential as a supportive tool in addressing the opioid epidemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering information about medication assisted treatment to individuals who misuse opioids through a mobile app: a pilot study. Cavazos-Rehg, PA., Krauss, MJ., Costello, SJ., et al.[2021]

The EMPOWER study is a comprehensive, multi-state, randomized controlled trial designed to help patients with chronic pain safely reduce long-term opioid use through three different approaches: cognitive behavioral therapy, self-management, and usual care.

By collecting detailed patient-reported data and using real-time feedback, the study aims to provide valuable insights into the effectiveness of these methods for opioid tapering, ultimately improving patient outcomes and satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of Cognitive Behavioral Therapy for Chronic Pain and Chronic Pain Self-Management within the Context of Voluntary Patient-Centered Prescription Opioid Tapering: The EMPOWER Study Protocol. Darnall, BD., Mackey, SC., Lorig, K., et al.[2021]

Approximately 32.9% of emergency department patients receiving opioid prescriptions were identified as 'at-risk' for abuse potential using the SOAPP-R screening tool, highlighting a significant concern for opioid misuse.

The SOAPP-R demonstrated a high negative predictive value (89%), suggesting it could be an effective screening tool to identify patients at low risk for opioid abuse in the emergency department setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of an opioid abuse screening tool and prescription drug monitoring data in the emergency department. Weiner, SG., Horton, LC., Green, TC., et al.[2022]

The EMPOWER study is addressing the urgent need for safe and effective strategies for tapering opioids in chronic pain patients, as current methods have high dropout rates and can increase patient distress.

A new consensus screening tool has been developed to help clinicians identify Opioid Use Disorder (OUD) and assess its severity, which is crucial for determining appropriate treatment pathways for patients on long-term opioid therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Brief Screening Tool for Opioid Use Disorder: EMPOWER Study Expert Consensus Protocol. You, DS., Mardian, AS., Darnall, BD., et al.[2021]

A web-based self-management intervention for chronic pain patients on opioids was developed based on feedback from 53 participants, highlighting the need for additional pain management strategies and the importance of goal setting.

Participants found the web-based tool potentially useful and acceptable, indicating that it effectively increased their knowledge about self-management of chronic pain, suggesting a promising approach for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients as collaborators: using focus groups and feedback sessions to develop an interactive, web-based self-management intervention for chronic pain. Moore, SK., Guarino, H., Acosta, MC., et al.[2022]

In a pilot study involving 60 adults with chronic pain and opioid use disorder, participants who used an online pain self-management program reported significant reductions in pain interference, pain severity, opioid misuse, and depressive symptoms after 8 weeks.

The study highlights that a majority of participants initially used opioids due to pain, indicating that effective pain management strategies like this online program could be crucial in addressing both pain and opioid misuse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engagement in online pain self-management improves pain in adults on medication-assisted behavioral treatment for opioid use disorders. Wilson, M., Finlay, M., Orr, M., et al.[2019]

Digital therapeutics, such as virtual reality apps, have been authorized by the FDA as effective treatments for chronic conditions like low back pain and can enhance the effectiveness of traditional medications like buprenorphine for opioid use disorder.

A review of randomized controlled trials showed that patients using digital interventions alongside opioid treatments generally reported better pain relief compared to those receiving standard care, highlighting the potential of these technologies in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunct Digital Interventions Improve Opioid-Based Pain Management: Impact of Virtual Reality and Mobile Applications on Patient-Centered Pharmacy Care. Giravi, HY., Biskupiak, Z., Tyler, LS., et al.[2022]

Behavioral approaches to managing chronic pain are proven to be effective and safe, yet they are often overlooked by medical professionals in favor of pharmacological treatments.

Internet-based interventions, including therapist-guided and unguided options, show promise in increasing the accessibility and use of behavioral pain management strategies, although there is significant variability in their design and empirical support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meeting them where they are: Using the Internet to deliver behavioral medicine interventions for pain. Rini, C., Williams, DA., Broderick, JE., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

"So, you must understand that that group changed everything": perspectives on a telehealth group intervention for individuals with chronic pain. [2023]

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

Design considerations for a remote randomized multi-site clinical trial evaluating an e-health self-management program for chronic pain patients receiving opioid therapy. [2023]

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

Longitudinal Treatment Outcomes for an Interdisciplinary Pain Rehabilitation Program: Comparisons of Subjective and Objective Outcomes on the Basis of Opioid Use Status. [2022]

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

Pain rehabilitation's dual power: Treatment for chronic pain and prevention of opioid-related risks. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Delivering information about medication assisted treatment to individuals who misuse opioids through a mobile app: a pilot study. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of Cognitive Behavioral Therapy for Chronic Pain and Chronic Pain Self-Management within the Context of Voluntary Patient-Centered Prescription Opioid Tapering: The EMPOWER Study Protocol. [2021]

7. Ireland pubmed.ncbi.nlm.nih.gov

A comparison of an opioid abuse screening tool and prescription drug monitoring data in the emergency department. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A Brief Screening Tool for Opioid Use Disorder: EMPOWER Study Expert Consensus Protocol. [2021]

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

Patients as collaborators: using focus groups and feedback sessions to develop an interactive, web-based self-management intervention for chronic pain. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Engagement in online pain self-management improves pain in adults on medication-assisted behavioral treatment for opioid use disorders. [2019]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Adjunct Digital Interventions Improve Opioid-Based Pain Management: Impact of Virtual Reality and Mobile Applications on Patient-Centered Pharmacy Care. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Meeting them where they are: Using the Internet to deliver behavioral medicine interventions for pain. [2021]