VANISH for Chronic Low Back Pain

NCT04236804 | Completed Results FDA Device

• 2 other identifiers: STUDY190502951R44DA049630-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Low-back Pain

Keywords

Virtual Autonomic Neuromodulation Induced Systemic Healing; TMC-CP01

Outcome Measures

Primary Outcomes (1)

• Assessment of Opioid Use Via Subject Report

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

  Week 0

Secondary Outcomes (43)

• Assessment of Opioid Use Via Subject Report

  Week 4

• Assessment of Opioid Use Via Subject Report

  Week 8

• Flowly (TMC-CP01) Virtual Reality Intervention Feasibility Via Change From Baseline in Heart Rate Variability (HRV) at 8 Weeks

  8 Weeks

• Change From Baseline in Opioid Cravings Using the Craving Index at 8 Weeks

  weekly, up to 8 weeks

• Change From Baseline in Physical Function Using PROMIS Physical Function Short Form T-score at 8 Weeks

  Assessed weekly, change from baseline and Week 8 reported

Study Arms (2)

TMC-CP01 Intervention

EXPERIMENTAL

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.

Device: Flowly (TMC-CP01)

Standard of Care

NO INTERVENTION

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

Interventions

Flowly (TMC-CP01) DEVICE

TMC-CP01 is a device designed specifically for pain management and is tailored for low back pain. The treatment utilizes virtual reality and biofeedback to train patients to auto-regulate themselves and improve their pain over time guidelines.

Also known as: Virtual Reality

TMC-CP01 Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females or males 18 years of age and older at screening
• Diagnosis of Chronic Lower Back Pain (CLBP) and a \>50mg MME daily opioid dosage
• Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments
• Signed informed consent form

You may not qualify if:

• Subjects who, in the opinion of the study site principal investigator, have a psychotic disorder, dementia, or other issue which may make accurate data reporting difficult
• Subjects who do not speak fluent English
• Patient refusal

Sponsors & Collaborators

• Ajay Wasan, MD, Msc: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

UPMC Pain Medicine At Centre Commons

Pittsburgh, Pennsylvania, 15206, United States

Location

Limitations and Caveats

The primary limitation of this study is the small sample size (n=20), which may impact statistical power and generalizability. While analyses were conducted, the limited number of participants affects the ability to detect statistically significant differences or draw broader conclusions. Larger trials are necessary to further evaluate the intervention's effects and determine its reproducibility in a larger population.

Results Point of Contact

• Title: Brian O'Connell
• Organization: University of Pittsburgh

oconnellb2@upmc.edu

3023997506

Study Officials

• Ajay Wasan, MD, MSc

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Anesthesiology and Perioperative Medicine and Psychiatry

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: January 22, 2020
• Study Start: June 17, 2020
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: April 11, 2025
• Results First Posted: April 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)