What is the mechanism of action of this treatment?

Virtual Reality (VR) works by immersing patients in a simulated environment that can distract them from pain and reduce pain perception through sensory engagement and cognitive distraction. Biofeedback involves monitoring physiological functions (e.g., muscle tension, heart rate) and providing real-time feedback to help patients gain control over these functions, thereby reducing pain and stress. Psychological exercises, such as cognitive-behavioral therapy (CBT) and mindfulness, help patients manage pain by changing their pain-related thoughts and behaviors, improving coping strategies, and reducing emotional distress. These treatments are particularly relevant for CLBP patients as they offer non-pharmacological options that can reduce reliance on opioids, improve pain management, and enhance overall quality of life.

What side effects are associated with this type of intervention?

Virtual Reality (VR) treatments for CLBP have shown promise in reducing pain intensity, but some studies indicate a high risk of bias and the need for longer follow-up to confirm enduring benefits. Side effects may include motion sickness or dizziness due to the immersive nature of VR. Biofeedback relaxation techniques are generally well-tolerated, with minimal reported side effects, making them a safe complementary treatment option. Psychological exercises, such as cognitive-behavioral therapy (CBT), are effective for pain management but can sometimes lead to temporary emotional discomfort as patients confront and work through their pain-related thoughts and behaviors.

What prior FDA approvals exist?

There is no specific mention of FDA approvals for treatments involving virtual reality, biofeedback, or psychological exercises for Chronic Lower Back Pain (CLBP) in the provided context. However, these modalities are being explored as part of innovative pain management strategies, such as the TMC-CP01 trial, which aims to reduce pain and opioid requirements in CLBP patients. Traditional pharmacologic treatments for CLBP often include NSAIDs, acetaminophen, and in some cases, antidepressants or antiepileptic agents, but these are not directly related to the TMC-CP01 approach.

What other types of research exist?

Promising, novel alternatives to TMC-CP01 for chronic lower back pain patients include: 1) Virtual Reality (VR) interventions for gradual exposure to feared movements and pain management, 2) Biofeedback relaxation techniques, which have shown significant pain reduction, 3) Cognitive Behavioral Therapy (CBT) for addressing associated insomnia and psychological well-being, and 4) Mindfulness and guided imagery practices, which have demonstrated effectiveness in reducing pain and improving quality of life.

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Behavioural Intervention

Flowly (TMC-CP01) for Chronic Low Back Pain (VANISH Trial)

N/A

Waitlist Available

Led By Ajay Wasan, MD, MSc

Research Sponsored by Ajay Wasan, MD, Msc

Eligibility Criteria Checklist

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

Must have

Diagnosis of Chronic Lower Back Pain (CLBP) and a >50mg MME daily opioid dosage

Be older than 18 years old

Must not have

Patient refusal

Subjects who do not speak fluent English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 8

Awards & highlights

No Placebo-Only Group

Summary

This trial uses TMC-CP01, a combination of virtual reality, biofeedback, and psychological exercises, to help patients with Chronic Low Back Pain manage their pain. The goal is to reduce reliance on opioids by teaching patients to control their body's responses to pain. Virtual reality has shown promising results in reducing pain intensity and fear of movement in patients with chronic low back pain.

Who is the study for?

This trial is for adults over 18 with Chronic Lower Back Pain who are currently taking more than 50mg of opioid medication daily. Participants must be able to understand the study, follow the schedule, and complete assessments. It's not suitable for those with certain mental health conditions, dementia, or non-English speakers.

What is being tested?

The TMC-CP01 program uses virtual reality along with biofeedback and psychological exercises aimed at managing chronic lower back pain. The goal is to improve pain management while reducing reliance on opioids.

What are the potential side effects?

Since this intervention involves non-pharmacological methods like virtual reality and biofeedback rather than drugs, typical drug side effects are not expected; however, participants may experience discomfort or dizziness associated with VR use.

Eligibility Criteria

Inclusion Criteria

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

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I have chronic lower back pain and take more than 50mg of opioids daily.

Exclusion Criteria

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

Select...

I have chosen not to participate in this trial.

Select...

I am not fluent in English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8 for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Assessment of Ability to Participate in Social Roles and Activities using PROMIS

Assessment of Anxiety level before vs after intervention via Flowly app

Assessment of Anxiety using PROMIS

+22 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TMC-CP01 InterventionExperimental Treatment1 Intervention

Ten patients will be randomly assigned to receive the TMC-CP01 intervention every day for 8 weeks in addition to their current opioid prescription and tapering guidelines.

Group II: Standard of CareActive Control1 Intervention

Ten patients will be randomly assigned to receive their current opioid prescription and tapering guidelines, as standard of care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Flowly (TMC-CP01)

2020

N/A

~30

0 / 3Eligibility 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

Virtual Reality (VR) works by immersing patients in a simulated environment that can distract them from pain and reduce pain perception through sensory engagement and cognitive distraction. Biofeedback involves monitoring physiological functions (e.g., muscle tension, heart rate) and providing real-time feedback to help patients gain control over these functions, thereby reducing pain and stress. Psychological exercises, such as cognitive-behavioral therapy (CBT) and mindfulness, help patients manage pain by changing their pain-related thoughts and behaviors, improving coping strategies, and reducing emotional distress. These treatments are particularly relevant for CLBP patients as they offer non-pharmacological options that can reduce reliance on opioids, improve pain management, and enhance overall quality of life.

Visually induced analgesia during massage treatment in chronic back pain patients.Virtual reality exergame for supplementing multimodal pain therapy in older adults with chronic back pain: a randomized controlled pilot study.Virtual Reality and the Mediation of Acute and Chronic Pain in Adult and Pediatric Populations: Research Developments.