VANISH for Chronic Low Back Pain
Completed · Not applicable
Conditions studied: Chronic Low-back Pain
In brief
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.
Key facts
- Study ID
- NCT04236804
- Run by
- Ajay Wasan, MD, Msc
- People needed
- 20
- Starts
- 2020-06-17
- Expected to finish
- 2024-01-01
- Last updated by the study team
- 2025-04-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- UPMC Pain Medicine At Centre Commons — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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