VANISH for Chronic Low Back Pain
CompletedNot applicableNCT04236804
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- VANISH (Virtual Autonomic Neuromodulation Induced Systemic Healing) for Chronic Low Back Pain (CLBP)
- Conditions
- Interventions
- Device: Flowly (TMC-CP01)
- Sponsor
- Ajay Wasan, MD, Msc
- Collaborators
- National Institutes of Health (NIH); National Institute on Drug Abuse (NIDA)
- Organization
- University of Pittsburgh
- Start date
- 2020-06-17
- Primary completion
- 2024-01-01
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04236804