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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8
Awards & highlights

VANISH Trial Summary

This trial will test a new program to manage pain for people with chronic low back pain using virtual reality, biofeedback, and psychological exercises.

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.Check my eligibility
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.See study design
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.

VANISH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have chronic lower back pain and take more than 50mg of opioids daily.

VANISH Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
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

VANISH 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)
2021
N/A
~10

Find a Location

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
2,696 Previous Clinical Trials
6,952,553 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,465 Previous Clinical Trials
2,618,607 Total Patients Enrolled

Media Library

Flowly (TMC-CP01) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04236804 — N/A
Chronic Lower Back Pain Research Study Groups: TMC-CP01 Intervention, Standard of Care
Chronic Lower Back Pain Clinical Trial 2023: Flowly (TMC-CP01) Highlights & Side Effects. Trial Name: NCT04236804 — N/A
Flowly (TMC-CP01) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04236804 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Implementing TMC-CP01 Treatment Based on the Virtual Autonomic Neuromodulation Induced Systemic Healing System in Reducing Pain and Opioid Requirement in Subjects Suffering From Chronic Low Back Pain
Ajay Wasan, MD, Msc 2020. "Implementing TMC-CP01 Treatment Based on the Virtual Autonomic Neuromodulation Induced Systemic Healing System in Reducing Pain and Opioid Requirement in Subjects Suffering From Chronic Low Back Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04236804.
All > Low Back Pain > Lower Back Pain
~3 spots leftby Oct 2024
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