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painTRAINER® for Chronic Pain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Chronic PainpainTRAINER® - Behavioral
Eligibility
13 - 99
All Sexes
What conditions do you have?
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Study Summary

This trial will compare two digital pain treatment programs to see if one is more effective than the other.

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 10 Secondary · Reporting Duration: Baseline

Baseline
Treatment Expectation
Week 12
Coping with Weekly Pain Questionnaire
Week 12
Treatment Usage Questionnaire
Week 8
Daily Pain Intensity
Opioid prescriptions of Morphine Milligram Equivalents (MME)
PROMIS Pain Interference 4a
Pain Catastrophizing scale 4 item short form
Pain Self-Efficacy Questionnaire (PSEQ) 2-item short form
Day 60
Coronavirus Anxiety
Patient-Reported Outcomes Measurement Information System Pain Interference 4a
Week 8
Pain Treatment Satisfaction

Trial Safety

Safety Progress

1 of 3

Similar Trials

3
Restylane-L® Lyft
3
Fleet Enema
1
VR-ECT 360o Video

Trial Design

4 Treatment Groups

painTRAINER (2D mHealth intervention)
1 of 4
2D mHealth intervention therapy
1 of 4
3D Immersive Virtual Reality (VR) therapy
1 of 4
Skills-based VR Therapy
1 of 4

Experimental Treatment

300 Total Participants · 4 Treatment Groups

Primary Treatment: painTRAINER® · No Placebo Group · N/A

painTRAINER (2D mHealth intervention)
Behavioral
Experimental Group · 1 Intervention: painTRAINER® · Intervention Types: Behavioral
2D mHealth intervention therapy
Behavioral
Experimental Group · 1 Intervention: painTRAINER® · Intervention Types: Behavioral
3D Immersive Virtual Reality (VR) therapy
Device
Experimental Group · 1 Intervention: PICO G2 4k · Intervention Types: Device
Skills-based VR Therapy
Device
Experimental Group · 1 Intervention: PICO G2 4k · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline

Who is running the clinical trial?

Stanford UniversityOTHER
2,169 Previous Clinical Trials
35,768,477 Total Patients Enrolled
30 Trials studying Chronic Pain
8,352 Patients Enrolled for Chronic Pain
Ochsner Health SystemOTHER
88 Previous Clinical Trials
185,483 Total Patients Enrolled
1 Trials studying Chronic Pain
478 Patients Enrolled for Chronic Pain
Northwestern UniversityOTHER
1,455 Previous Clinical Trials
789,396 Total Patients Enrolled
11 Trials studying Chronic Pain
3,699 Patients Enrolled for Chronic Pain
University of Alabama at BirminghamOTHER
1,434 Previous Clinical Trials
2,228,912 Total Patients Enrolled
6 Trials studying Chronic Pain
5,630 Patients Enrolled for Chronic Pain
Cedars-Sinai Medical CenterLead Sponsor
456 Previous Clinical Trials
153,935 Total Patients Enrolled
3 Trials studying Chronic Pain
1,328 Patients Enrolled for Chronic Pain
Brennan Spiegel, MD, MSHSPrincipal InvestigatorCedars-Sinai Medical Center
8 Previous Clinical Trials
1,842 Total Patients Enrolled
2 Trials studying Chronic Pain
1,083 Patients Enrolled for Chronic Pain

Eligibility Criteria

Age 13 - 99 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
We will exclude patients who: (1) have a condition that interferes with use of the intervention (e.g., visual impairment); (2) are hospitalized; (3) are receiving active cancer treatment; (4) are receiving end-of-life care; or (5) have cognitive impairment that affects participation.
We will recruit patients who: (1) have chronic pain, from any underlying condition, using the administrative definition of ICD-10 code series G89.
References

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