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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 8 weeks
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 belowSelect...
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 ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
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 moreAwards & 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
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.
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.
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Who is running the clinical trial?
Ajay Wasan, MD, MscLead Sponsor
2 Previous Clinical Trials
341 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,842 Previous Clinical Trials
8,173,124 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,607 Previous Clinical Trials
3,329,909 Total Patients Enrolled
Ajay Wasan, MD, MScPrincipal Investigator - University of Pittsburgh
UPMC Mercy
University Of Illinois College Of Medicine (Medical School)
Brigham & Women'S Hospital (Residency)
1 Previous Clinical Trials
330 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have chronic lower back pain and take more than 50mg of opioids daily.I am 18 years old or older.I have chosen not to participate in this trial.I am not fluent in English.
Research Study Groups:
This trial has the following groups:- Group 1: TMC-CP01 Intervention
- Group 2: Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.