What side effects are associated with this type of intervention?

Non-pharmacologic treatments for chronic pain, such as acupuncture, hypnotherapy, and cannabis, generally have fewer side effects compared to pharmacologic treatments. Acupuncture may cause minor side effects like bruising or soreness at needle sites. Hypnotherapy is generally safe but may cause temporary dizziness or anxiety in some individuals. Cannabis, while effective for some, can lead to psychoactive effects, dependency, and respiratory issues if smoked. Physical modalities like TENS and neurostimulation are usually well-tolerated but can cause skin irritation or discomfort at the application site.

What prior FDA approvals exist?

The FDA has approved several pharmacologic treatments for chronic pain, including NSAIDs, acetaminophen, and certain antidepressants like duloxetine. However, non-pharmacologic, evidence-based strategies such as cognitive-behavioral therapy (CBT) and physical therapy are also widely recommended for chronic pain management. These approaches focus on behavioral and lifestyle modifications to improve pain management and overall function. While specific FDA approvals for non-pharmacologic treatments are not typically required, these methods are supported by clinical guidelines and research evidence.

What other types of research exist?

Promising novel alternatives to non-pharmacologic evidence-based strategies for chronic pain patients include: 1) Multidisciplinary biopsychosocial rehabilitation, which integrates physical, psychological, and social aspects of care. 2) Technology-enhanced delivery of cognitive-behavioral therapy (CBT), such as online interventions and smartphone applications. 3) Mindfulness-based programs tailored for specific populations, like Veterans. 4) Acupuncture and hypnotherapy, which have shown potential benefits in some studies. 5) Medical cannabis, which may be beneficial for certain patients. These approaches aim to optimize engagement, adherence, and sustainability in chronic pain management.

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Mindfulness-Based Intervention

Mindfulness-Based Interventions for Chronic Pain (LAMP Trial)

N/A

Waitlist Available

Research Sponsored by United States Department of Defense

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weighted average over 10 weeks, 6 months, and 12 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests two mindfulness programs to help Veterans with chronic pain. One program uses a mobile app and group sessions, while the other uses just the mobile app. The goal is to teach Veterans mindfulness techniques to manage their pain better. Mindfulness-based interventions (MBIs) are evidence-based nonpharmacological treatments for treating chronic pain.

Who is the study for?

This trial is for Veterans with chronic pain lasting over 6 months and a severity score of at least 4 out of 10. Participants must have access to a smartphone compatible with the app, internet access, and be available for video conference sessions. Those in other pain studies or with certain mental health conditions are excluded.

What is being tested?

The study tests two mindfulness-based interventions delivered via mobile app: one that's just the app (Mobile LAMP) and another combining the app with group sessions (Mobile+Group LAMP). The goal is to see if these can help reduce chronic pain among Veterans.

What are the potential side effects?

Since this trial involves non-pharmacologic interventions like mindfulness practices through an app, side effects are minimal but may include discomfort or frustration during initial learning or potential stress from technological issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weighted average over 10 weeks, 6 months, and 12 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weighted average over 10 weeks, 6 months, and 12 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and weighted average over 10 weeks, 6 months, and 12 months. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in the Brief Pain Inventory (BPI) Interference Score From Baseline, Over the 12-month Follow-up Period.

Secondary study objectives

BPI Interference Score Responder Analysis

Change in Anxiety Over the 12-month Follow-up Period Assessed by Mean Score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 Measure of Anxiety

Change in Depression Over the 12-month Follow-up Period Assessed by Score on the Eight-item Patient Health Questionnaire Depression Scale (PHQ8)

+7 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Mobile+Group LAMP Mindfulness-Based InterventionExperimental Treatment1 Intervention

8 weekly, synchronous interactive online group sessions; access to mobile app and a study website, with an accompanying workbook.

Group II: Mobile LAMP Mindfulness-Based InterventionExperimental Treatment1 Intervention

8 weekly asynchronous sessions, delivered on mobile app and study website, with an accompanying workbook; 3 engagement calls at the middle, beginning and end of the program.

Group III: Usual CareActive Control1 Intervention

Engagement in usual care for 12 months as participants normally would. After the entire follow-up period is complete (12 months), participants in the usual care arm are given access to the Mobile LAMP materials MBI training on the app and study website, and the accompanying workbook.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mobile LAMP Mindfulness-Based Intervention

2020

N/A

~820

Mobile+Group LAMP Mindfulness-Based Intervention

2020

N/A

~820

Do I qualify?Apply below to find out

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, particularly non-pharmacologic evidence-based strategies, work through various mechanisms. Exercise therapy improves physical function and reduces pain by strengthening muscles and enhancing flexibility. Cognitive Behavioral Therapy (CBT) addresses the psychological aspects of pain, helping patients reframe negative thoughts and develop coping strategies. Mindfulness-Based Stress Reduction (MBSR) and other mind-body interventions like yoga and Tai-chi combine physical movement with mental focus, reducing stress and improving pain perception. These approaches are essential for chronic pain patients as they provide holistic pain management, encouraging active participation in their care and potentially leading to better outcomes and enhanced quality of life.

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