N/A N=20 Randomized Treatment

VANISH for Chronic Low Back Pain

Chronic Low-back Pain

Bottom Line

View on ClinicalTrials.gov: NCT04236804 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2025

Primary outcome: Primary: Assessment of Opioid Use Via Subject Report — 47.5; 21.75 morphine milligram equivalent

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Flowly (TMC-CP01) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ajay Wasan, MD, Msc
Primary completion: Jan 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Assessment of Opioid Use Via Subject Report	47.27; 10.62	—
SECONDARY Assessment of Opioid Use Via Subject Report	47.27; 10.62	—
SECONDARY Assessment of Opioid Use Via Subject Report	47.27; 10.62	—
SECONDARY Flowly (TMC-CP01) Virtual Reality Intervention Feasibility Via Change From Baseline in Heart Rate Variability (HRV) at 8 Weeks	—	—
SECONDARY Change From Baseline in Opioid Cravings Using the Craving Index at 8 Weeks	0.60; 0.83	—
SECONDARY Change From Baseline in Physical Function Using PROMIS Physical Function Short Form T-score at 8 Weeks	0.07; -1.41	—
SECONDARY Change From Baseline in Fatigue Using PROMIS Fatigue Short Form T-score at 8 Weeks	0.17; 0.61	—
SECONDARY Change From Baseline in Pain Interference Using the PROMIS Pain Interference Short Form at 8 Weeks	-1.47; -1.75	—
SECONDARY Change From Baseline in Pain Intensity Using the PROMIS Pain Intensity Item at 8 Weeks	0.2; 0.14	—
SECONDARY Change From Baseline in Sleep Disturbance Using the PROMIS Sleep Disturbance Short Form at 8 Weeks	-1.82; -0.47	—
SECONDARY Change From Baseline in Ability to Participate in Social Roles and Activities Using the PROMIS Short Form at 8 Weeks	1.95; 0.04	—
SECONDARY Change From Baseline in Depression Using the PROMIS Short Form at 8 Weeks	-1.08; -3.22	—
SECONDARY Change From Baseline in Anxiety Using the PROMIS Short Form at 8 Weeks	-4.05; -2.62	—
SECONDARY Change From Baseline in Loneliness Using the PROMIS Emotional Support Short Form at 8 Weeks	-2; -4	—
SECONDARY Assessment of Feelings About Pain	14.9; 16.5	—
SECONDARY Assessment of Feelings About Pain	14.9; 16.5	—
SECONDARY Assessment of Feelings About Pain	14.9; 16.5	—
SECONDARY Assessment of Salivary Cortisol Levels	6.72; 8.38	—
SECONDARY Assessment of Salivary Cortisol Levels	6.72; 8.38	—
SECONDARY Assessment of Salivary Cortisol Levels	6.72; 8.38	—
SECONDARY Assessment of Opioid Use Via Urinalysis	—	—
SECONDARY Assessment of Opioid Use Via Urinalysis	—	—
SECONDARY Assessment of Opioid Use Via Urinalysis	—	—
SECONDARY Assessment of Withdrawal Symptoms Using Opiate Withdrawal Scale	7.6; 5.67	—
SECONDARY Assessment of Withdrawal Symptoms Using Opiate Withdrawal Scale	7.6; 5.67	—
SECONDARY Assessment of Withdrawal Symptoms Using Opiate Withdrawal Scale	7.6; 5.67	—
SECONDARY Assessment of Beliefs About Pain Using Pain Catastrophizing Scale	27.1; 23.71	—
SECONDARY Assessment of Beliefs About Pain Using Pain Catastrophizing Scale	27.1; 23.71	—
SECONDARY Assessment of Beliefs About Pain Using Pain Catastrophizing Scale	27.1; 23.71	—
SECONDARY Assessment of Treatment Expectancy Using the Treatment Expectancy Short Form at Week 0	50.19; 51.33	—
SECONDARY Assessment of Treatment Expectancy Using the Treatment Expectancy Short Form at Week 4	46.04; 51.43	—
SECONDARY Assessment of Treatment Expectancy Using the Treatment Expectancy Short Form at Week 8	50.48; 43.98	—
SECONDARY Assessment of Positive Outlook Using the Positive Outlook Short Form at Week 0	46.06; 50.22	—
SECONDARY Assessment of Positive Outlook Using the Positive Outlook Short Form at Week 4	46.77; 53.43	—
SECONDARY Assessment of Positive Outlook Using the Positive Outlook Short Form at Week 8	46.86; 50.48	—
SECONDARY Assessment of Recent Behaviors Using the Current Opioid Misuse Measure (COMM)	10.10; 3.17	—
SECONDARY Assessment of Recent Behaviors Using the Current Opioid Misuse Measure (COMM)	10.10; 3.17	—
SECONDARY Assessment of Recent Behaviors Using the Current Opioid Misuse Measure (COMM)	10.10; 3.17	—
SECONDARY Assessment of Task Absorption Using the Tellegen Absorption Scale (TAS) at Week 0	10.2; 14.3	—
SECONDARY Assessment of Task Absorption Using the Tellegen Absorption Scale (TAS) at Week 4	9.22; 17.67	—
SECONDARY Assessment of Task Absorption Using the Tellegen Absorption Scale (TAS) at Week 8	8.4; 16	—
SECONDARY Change in Pain Level Before vs After Intervention Via Flowly App	0.2; 0.14	—
SECONDARY Change in Anxiety Level From Baseline to 8 Weeks Via Flowly App	-4.05; -2.62	—
SECONDARY Change in Depression Level From Baseline to 8 Weeks Via Flowly App	-1.08; -3.22	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04236804). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.