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NCT04236804 · ClinicalTrials.gov registry record · NA

VANISH for Chronic Low Back Pain

A NA study, sponsored by Ajay Wasan, MD, Msc.

Completed
Registry status
NA
Development phase
20
Enrollment target

NCT04236804: Completed NA study, sponsored by Ajay Wasan, MD, Msc.

NCT04236804 is a NA study that has completed, run by Ajay Wasan, MD, Msc. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04236804, a NA study, has completed, sponsored by Ajay Wasan, MD, Msc.

COMPLETED
Registry status
NA
Development phase
20 participants
Enrollment target

Study Summary

The program, called TMC-CP01, will use a combination of virtual reality, biofeedback, and psychological exercises to manage pain associated with Chronic Low Back Pain. Chronic pain affects an estimated 100 million Americans, around one-third of the U.S. population. One of the most prevalent conditions under chronic pain is Chronic Low Back Pain (CLBP). About 27% of chronic pain patients experience CLBP. It is the leading cause of disability in the world and 31 million Americans suffer from CLBP. The most common analgesic tool for pain patients, especially for LBP patients, is opioids. However, opioid users are subject to drug tolerance and physical dependence, which decreases efficacy and increases risk of complication. Long-term users often require doses up to ten times their original dose to achieve equivalent analgesia and, after months of exposure, patients' risk of addiction increases. This project aims to introduce a digital intervention to standard CLBP management with a virtual reality-enabled pain management system that will improve pain management and decrease daily dosages of opioids.

Primary Outcome

Daily dose of oral opioids recorded as morphine equivalents will be collected

Interventions

  • DEVICE Flowly (TMC-CP01)

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2020-06-17
Est. Completion 2024-01-01
Phase NA
Ajay Wasan, MD, Msc

4 total trials

What the finished NCT04236804 record still lists

NCT04236804 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Flowly (TMC-CP01) is the first listed.

NCT04236804 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04236804 about?

NCT04236804 is a clinical study titled "VANISH for Chronic Low Back Pain". The program, called TMC-CP01, will use a combination of virtual reality, biofeedback, and psychological exercises to manage pain associated with Chronic Low Back Pain. Chronic pain affects an estimated 100 million Americans, around one-third of the U.S. population. One of the most prevalent conditio...

What is the current status of trial NCT04236804?

This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2020-06-17. Estimated completion is 2024-01-01.

What interventions are being tested in trial NCT04236804?

The interventions under investigation include: Flowly (TMC-CP01) (DEVICE).

Who is sponsoring clinical trial NCT04236804?

This trial is sponsored by Ajay Wasan, MD, Msc, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04236804's enrollment target sits among peer trials

20 1768th of 2000 higher than 140 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04236804, the US trial registry maintained by the National Library of Medicine. NCT04236804 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.