What side effects are associated with this type of intervention?

Non-pharmacologic treatments for chronic pain, such as self-regulatory skills, cognitive-behavioral therapy (CBT), and physical therapy, generally have minimal side effects. Patients may experience temporary discomfort or emotional distress as they confront pain-related thoughts and behaviors. In contrast, pharmacologic treatments like NSAIDs can cause gastrointestinal issues, renal side effects, and increased risk of myocardial infarction, while antidepressants may lead to sedation, weight gain, and sexual dysfunction. Overall, non-pharmacologic approaches are considered safer but may require more time and patient engagement to be effective.

What prior FDA approvals exist?

The FDA has approved various treatments for chronic pain, including both pharmacologic and non-pharmacologic approaches. Pharmacologic treatments include antidepressants like duloxetine (an SNRI) and antiepileptic agents such as gabapentin and pregabalin, which are used for neuropathic pain. Non-pharmacologic treatments that align with the self-regulatory skills approach of the Empowered Relief (ER) class include cognitive-behavioral therapy (CBT) and other psychological interventions. While specific FDA approvals for self-regulatory skills programs are not detailed, these therapies are widely recognized and recommended in clinical guidelines for chronic pain management.

What other types of research exist?

Promising, novel alternatives to the Empowered Relief (ER) class for chronic pain management include: <ol> <li>Guided Imagery and Progressive Muscle Relaxation: These techniques have shown effectiveness in reducing pain in cancer patients and could be beneficial for chronic pain management.</li> <li></li> </ol> Biofeedback: EMG biofeedback-assisted relaxation has been effective in reducing chronic pain in cancer patients and may offer benefits for other chronic pain conditions. 3. Mindfulness-Based Stress Reduction (MBSR): This evidence-based program uses meditation practices to increase awareness and self-regulation, which can help manage chronic pain. 4. Cognitive Distraction Techniques: Activities like playing video games during treatment can help reduce pain perception. 5. Transcutaneous Electrical Nerve Stimulation (TENS): Although evidence is mixed, TENS may provide symptomatic relief for some patients. 6. Neurofeedback: This technique has shown potential benefits for chemotherapy-induced peripheral neuropathy and could be explored for other types of chronic pain.

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Empowered Relief Class for Chronic Pain

N/A

Waitlist Available

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Chronic Pain (> 3 months)

Taking Methadone or Buprenorphine

Must not have

Severe Depression

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 month post-tx

Awards & highlights

No Placebo-Only Group

Summary

This trial tests an online pain management class called Empowered Relief for patients with chronic pain who take methadone or buprenorphine. Buprenorphine has been used for chronic pain management and opioid maintenance, with a history of being effective in these areas. The class teaches about pain and self-management skills. The study will check if the class is practical, how patients feel about it, and its benefits over time.

Who is the study for?

This trial is for adults over 18 with chronic pain lasting more than 3 months who are currently taking methadone or buprenorphine. Participants must be fluent in English. It's not suitable for pregnant individuals, those with severe cognitive issues, acute suicidal thoughts, or severe depression.

What is being tested?

The study tests a virtual 'Empowered Relief' class designed to teach self-regulation skills and create daily personalized plans for managing chronic pain. Its effectiveness will be evaluated through participant feedback and surveys over a three-month period post-treatment.

What are the potential side effects?

Since the intervention involves educational classes rather than medication, there are no direct medical side effects expected from participating in this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been experiencing pain for more than 3 months.

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I am currently taking Methadone or Buprenorphine.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with severe depression.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 month post-tx

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 month post-tx

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 month post-tx for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Likelihood of using the skills

Participant satisfaction

Perceived usefulness/utility

Secondary study objectives

PCS total scores

Pain Bothersomness

Pain Intensity

+1 more

Other study objectives

Anxiety

Craving

Depression

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Empowered ReliefExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Empowered Relief class

2021

N/A

~50

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for chronic pain, such as those studied in the Empowered Relief (ER) class, often involve self-regulatory skills like cognitive-behavioral therapy (CBT), mindfulness-based stress reduction (MBSR), and pain neuroscience education (PNE). These approaches work by altering the patient's perception of pain, reducing stress, and enhancing coping mechanisms. By focusing on mental and emotional strategies to manage pain, these treatments can decrease the need for medications and improve the overall quality of life for chronic pain patients.

Pathophysiologic Approach to Pain Therapy for Complex Pain Entities: A Narrative Review.