NCT04236804: VANISH

VANISH for Chronic Low Back Pain

Completed NA Results posted Last updated 11 April 2025

What this trial tests

NA trial testing Flowly (TMC-CP01) in Chronic Low-back Pain in 20 participants. Completed in 1 January 2024.

Timeline

17 June 2020

Primary endpoint
1 January 2024

1 January 2024

Quick facts

Lead sponsor	Ajay Wasan, MD, Msc
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	17 June 2020
Primary completion	1 January 2024
Estimated completion	1 January 2024
Sites	1 location across United States

Drugs / interventions tested

• Flowly (TMC-CP01)

Conditions studied

• Chronic Low-back Pain — all drugs for Chronic Low-back Pain →

Sponsor

Ajay Wasan, MD, Msc — full company profile →

Who can join

18 and older, any sex, with Chronic Low-back Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Assessment of Opioid Use Via Subject Report Primary · Week 0

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

Group	Value	95% CI
TMC-CP01 Intervention	47.5	± 36.53
Standard of Care	21.75	± 23.19

Assessment of Opioid Use Via Subject Report Secondary · Week 4

The amount and dosing of opioid medications taken by each subject will be recorded throughout the study. The lower the average daily morphine milligram equivalent \[MME\], the better the outcomes. Outcomes will be measured over the span of the study and compared between the two groups.

Group	Value	95% CI
TMC-CP01 Intervention	47.27	± 36.77
Standard of Care	10.75	± 7.34

Assessment of Opioid Use Via Subject Report Secondary · Week 8

The amount and dosing of opioid medications taken by each subject will be recorded throughout the study. The lower the average daily morphine milligram equivalent \[MME\], the better the outcomes. Outcomes will be measured over the span of the study and compared between the two groups.

Group	Value	95% CI
TMC-CP01 Intervention	47.27	± 36.77
Standard of Care	10.62	± 7.36

Change From Baseline in Opioid Cravings Using the Craving Index at 8 Weeks Secondary · weekly, up to 8 weeks

The Craving Index questionnaire on the Flowly app assesses opioid cravings using 6 qualitatively scaled questions, ranging from 'none' (minimum score: 0) to 'the greatest possibility' (maximum score: 5 per question, total score: 30). Lower scores indicate less frequent opioid cravings, suggesting better outcomes. Measurements were assessed weekly, and the analysis focused on comparing scores between baseline and 8 weeks to evaluate changes in cravings between the two groups.

Group	Value	95% CI
TMC-CP01 Intervention	0.60	± 7.56
Standard of Care	0.83	± 4.92

Change From Baseline in Physical Function Using PROMIS Physical Function Short Form T-score at 8 Weeks Secondary · Assessed weekly, change from baseline and Week 8 reported

The investigators used the PROMIS Physical Function Short Form T-score to assess key patient-centered outcomes related to physical function. This assessment includes 4 physical function-related questions, each scored on a 5-point Likert scale (1 = unable to do, 5 = without any difficulty). The raw total score ranges from a minimum of 4 to a maximum of 20. Responses were converted to T-scores, where the mean in the general population is 50 with a standard deviation of 10. Higher T-scores indicate better physical function, while lower T-scores suggest worse physical function. Clinically relevan

Group	Value	95% CI
TMC-CP01 Intervention	0.07	± 2.89
Standard of Care	-1.41	± 4.24

Change From Baseline in Fatigue Using PROMIS Fatigue Short Form T-score at 8 Weeks Secondary · Baseline and Week 8

The investigators used the PROMIS Fatigue Short Form T-score to assess key patient-centered outcomes related to fatigue. This assessment includes 4 fatigue-related questions, each scored on a 5-point Likert scale (1 = not at all, 5 = very much). The raw total score ranges from a minimum of 4 to a maximum of 20. Responses were converted to T-scores, where the mean in the general population is 50 with a standard deviation of 10. Higher T-scores indicate greater fatigue, while lower T-scores suggest less fatigue, which reflects better outcomes. Clinically relevant thresholds suggest that elevate

Group	Value	95% CI
TMC-CP01 Intervention	0.17	± 5.05
Standard of Care	0.61	± 8.09

Change From Baseline in Pain Interference Using the PROMIS Pain Interference Short Form at 8 Weeks Secondary · Assessed weekly, change from baseline and Week 8 reported

The investigators used the PROMIS Pain Interference Short Form to assess how pain impacts daily activities. This measure includes 5 pain-related questions, each scored on a 5-point Likert scale (1 = not at all, 5 = very much). The raw total score (range: 5 to 25) was converted to a standardized T-score (mean = 50, SD = 10). Higher T-scores indicate greater pain interference, while lower T-scores suggest less interference (better outcomes). A T-score of 60+ may indicate clinically significant pain interference, while 40 or lower suggests minimal interference. Measurements were conducted over

Group	Value	95% CI
TMC-CP01 Intervention	-1.47	± 3.69
Standard of Care	-1.75	± 3.22

Change From Baseline in Pain Intensity Using the PROMIS Pain Intensity Item at 8 Weeks Secondary · Assessed weekly, change from baseline and Week 8 reported

The investigators used the PROMIS Pain Intensity Item to assess patients' self-reported pain levels. This measure consists of one question, scored on an 11-point Likert scale (0 = no pain, 10 = worst imaginable pain). The raw score was converted to a standardized T-score (mean = 50, SD = 10). Higher T-scores indicate greater pain intensity, while lower T-scores suggest less pain (better outcomes). A T-score of 60+ may indicate clinically significant pain, while 40 or lower suggests mild or minimal pain. Measurements were conducted throughout the study, with scores compared between baseline a

Group	Value	95% CI
TMC-CP01 Intervention	0.2	± 1.32
Standard of Care	0.14	± 1.07

Change From Baseline in Sleep Disturbance Using the PROMIS Sleep Disturbance Short Form at 8 Weeks Secondary · Assessed weekly, change from baseline and Week 8 reported

The investigators used the PROMIS Sleep Disturbance Short Form to assess patient-reported sleep difficulties. This measure includes 4 items, each rated on a 5-point Likert scale (1 = not at all, 5 = very much). The raw score (range: 4 to 20) was converted to a T-score (mean = 50, SD = 10). Higher T-scores indicate greater sleep disturbance (worse outcomes), while lower T-scores suggest better sleep quality. A T-score of 60+ may indicate clinically significant sleep disturbance, while 40 or lower suggests minimal issues. Measurements were conducted throughout the study, with scores compared b

Group	Value	95% CI
TMC-CP01 Intervention	-1.82	± 5.73
Standard of Care	-0.47	± 4.51

Change From Baseline in Ability to Participate in Social Roles and Activities Using the PROMIS Short Form at 8 Weeks Secondary · Assessed weekly, change from baseline and Week 8 reported

The investigators used the PROMIS Ability to Participate in Social Roles and Activities Short Form to assess social participation. This measure includes 4 items, each rated on a 5-point Likert scale (1 = never, 5 = always). The raw score (range: 4 to 20) was converted to a T-score (mean = 50, SD = 10). Higher T-scores indicate greater ability to engage in social roles and activities (better outcomes), while lower scores suggest more social restrictions. A T-score below 40 may indicate clinically significant limitations in social participation. Measurements were conducted throughout the study

Group	Value	95% CI
TMC-CP01 Intervention	1.95	± 5
Standard of Care	0.04	± 4.23

Change From Baseline in Depression Using the PROMIS Short Form at 8 Weeks Secondary · Assessed weekly, change from baseline and Week 8 reported

The investigators used the PROMIS Depression Short Form to assess depressive symptoms. This measure includes 4 items, each rated on a 5-point Likert scale (1 = never, 5 = always). The raw score (range: 4 to 20) was converted to a T-score (mean = 50, SD = 10). Higher T-scores indicate greater levels of depression (worse outcomes), while lower scores reflect fewer depressive symptoms. A T-score above 60 suggests clinically significant depression, while a T-score below 50 reflects better mental health relative to the general population. Measurements were conducted throughout the study, with sco

Group	Value	95% CI
TMC-CP01 Intervention	-1.08	± 4.21
Standard of Care	-3.22	± 6.35

Change From Baseline in Anxiety Using the PROMIS Short Form at 8 Weeks Secondary · Assessed weekly, change from baseline and Week 8 reported

The investigators used the PROMIS Anxiety Short Form to assess anxiety symptoms. This measure includes 4 items, each rated on a 5-point Likert scale (1 = never, 5 = always). The raw score (range: 4 to 20) was converted to a T-score (mean = 50, SD = 10). Higher T-scores indicate greater levels of anxiety (worse outcomes), while lower scores reflect reduced anxiety symptoms. A T-score above 60 suggests clinically significant anxiety, while a T-score below 50 reflects better emotional health relative to the general population. Measurements were conducted throughout the study, with scores compar

Group	Value	95% CI
TMC-CP01 Intervention	-4.05	± 7.79
Standard of Care	-2.62	± 5.59

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Virtual Reality in the Treatment of Adults with Chronic Low Back Pain: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.
   Brea-Gómez B, Torres-Sánchez I, Ortiz-Rubio A, Calvache-Mateo A, et al · · 2021 · cited 57× · PMID 34831562 · DOI 10.3390/ijerph182211806