Pragmatic Comparative Effectiveness Trial of Evidence-based, On-demand, Digital Behavioral Treatments for Chronic Pain

NCT04933474 | Completed Results DMC FDA Device

• 2 other identifiers: STUDY000012621R01NR019947-01
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

This study compared two available, evidence-based, at-home digital pain treatment programs. The goal is to see if one approach is better than the other, and whether certain patients respond to one more than the other. Study participants will be randomly assigned to receive one of two treatment programs: Skills-Based VR or painTRAINER. VR devices and painTRAINER manuals will be delivered to the participant's home with instructions for use via FedEx; participants will receive remote technical support. They will be followed for 12 weeks and complete Patient Reported Outcome (PRO) questionnaires to assess functional status, pain levels, and use of pain medications (including opioids). Participants will also be asked to provide consent/authorization to access medical records from their treating facility.

Conditions

Chronic Pain

Keywords

Virtual Reality; Web App; Digital Health; Rural

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 8 in Daily Pain Intensity

  \[Alternative Title: Proportion of Participants with \>=2 Change in Average of 7 Daily Pain Intensity Questionnaires\] The change from study baseline to week 8 in daily pain intensity was measured using the standard 11-point numeric rating scale (NRS) with a 24-hour recall. Daily pain NRS was measured for 7-days during baseline and again during the final week of the study (week 8). This outcome is the baseline vs. week 8 difference-in-difference in 7-day average NRS pain intensity scores, dichotomized into if the minimally clinically importance difference (MCID) of 2 is achieved. NRS is positively scored, where higher scores indicate worse pain intensity. The difference from baseline is reported as Baseline - Week 8, therefore a higher difference corresponds to improvement of symptoms (reduced pain intensity). The difference-in-difference is dichotomized into if the MCID of 2 is achieved, reported as the proportion of participants by arm.

  From baseline to end of treatment at Week 8

Secondary Outcomes (5)

• Change in Patient-Reported Outcomes Measurement Information System Pain Interference 4a (PROMIS-PI) T-score

  From baseline to end of treatment at Week 8

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety T-score

  From baseline to end of treatment at Week 8

• Change in 2-item Pain Self-Efficacy Questionnaire (PSEQ-2)

  From baseline to end of treatment at Week 8

• Change in 4-item Pain Catastrophizing Scale (briefPCS)

  From baseline to end of treatment at Week 8

• Change in Weekly Opioid Use (Use or No Use)

  From baseline to end of treatment at Week 8

Study Arms (2)

painTRAINER (2D mHealth intervention)

EXPERIMENTAL

painTRAINER® is an 8-week, self-administered mobile health (mHealth) program. The painTRAINER® program delivers skills training and cognitive behavioral therapy (CBT)-related treatments through 8 weekly sessions as well as optional practice modules available between sessions. It is accessible by visiting https://mypaintrainer.org/ on most devices with a web browser, including computers, smartphones, and tablets. Participants assigned to the painTRAINER® intervention were mailed a physical workbook created by the painTRAINER® team to assist users in their progress through the program.

Behavioral: painTRAINER®

Skills-Based VR (3D VR intervention)

EXPERIMENTAL

EaseVRx+ incorporates the evidence-based principles of CBT, mindful meditation, and physiologic biofeedback therapy using embedded biometric sensors. It combines psychoeducation, pain education, breathing training, relaxation exercises, and executive functioning games to provide a mind-body approach toward living better with chronic pain. The standardized, prescriptive, and reproducible 56-day program delivers a combination of skills training and CBT-related treatments through scheduled daily virtual experiences. EaseVRx+ also features an on-demand library, allowing users to access any of the unique video sessions as needed.

Device: Skills-Based VR

Interventions

Skills-Based VR DEVICE

Participants will use the Pico G2 4K VR audio and visual head-mounted device, loaded with the EaseVRx+ software. The Pico G2 4K is a standalone VR headset that comes with an orientation-tracked controller. It does not require a smartphone or personal computer to operate. The device supports 3 degrees of freedom (3DOF) head tracking, has best-in-class optics, and a wide field-of-view. The headset battery requires recharging after approximately 2.5 hours of use. https://www.pico-interactive.com/us/G2\_4K.html

Also known as: EaseVRx+ Software, PICO G2 4k

Skills-Based VR (3D VR intervention)

painTRAINER® BEHAVIORAL

PainTRAINER is among the most widely-validated mHealth interventions for pain management.18-25 Originally developed by members of our team at Duke and Northwestern University under NIH funding, the app teaches evidence-based pain coping skills using a self-administered, home-based software program. The system delivers eight sessions via any web-connected platform, including Android or iOS smartphones, tablets, or personal computers. The digital curriculum covers progressive muscle relaxation, activity/rest cycling, pleasant activity scheduling, recognizing negative automatic thoughts, pleasant imagery/distraction, problem solving, and monitoring for maintenance. Patients complete one session per week in a pre-determined order. The program can be completed in a flexible manner to accommodate life and medical events.

painTRAINER (2D mHealth intervention)

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

We will recruit patients who: (1) have chronic pain, from any underlying condition, using the administrative definition of ICD-10 code series G89.X or one or more of 134 chronic overlapping pain condition codes, as previously standardized and validated by an expert panel, (2) have experienced average pain intensity of \>3 out of 10 within the previous week, (3) are ≥13 years of age, (4) are able to read/write English, (5) have either a personal computer or a smartphone, and (6) live in a designated rural zip code as defined by the Federal Office of Rural Health Policy (FORHP) data (RUCA Codes 4-10). We will exclude patients who: (1) have a condition that interferes with use of the intervention (e.g., significant visual or auditory impairment, any history of seizure), (2) are hospitalized, (3) are receiving active cancer treatment, (4) are receiving end-of-life care, (5) have cognitive impairment that affects participation, or (6) have previously used the EaseVRx+ or painTRAINER programs. We will stratify analyses across key patient characteristics, including type of pain condition, sex, age, race, ethnicity, State and zip code, Rural-Urban Commuting Area (RUCA) codes (a composite measure of population density, urbanization, and daily commuting), pain severity, opioid use, comorbidities, social support, and COVID-19 impacts (unemployment, financial hardship, family or personal COVID-19 diagnosis).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• Northwestern University: collaborator
• Stanford University: collaborator
• University of Alabama at Birmingham: collaborator
• Ochsner Health System: collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Survey responses contained 2-week response windows, so responses at a point in time do not necessarily reflect the actual difference in days. Variation exists in day difference between baseline measurements and start of study intervention due to variation and delays in the shipping of study devices to participants' homes and the availability of participants to complete protocolized onboarding phone calls.

Results Point of Contact

• Title: Samuel Eberlein
• Organization: Cedars-Sinai Medical Center

samuel.eberlein@cshs.org

310-423-6721

Study Officials

• Brennan Spiegel, MD, MSHS

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Providers, Primary Investigator, and Biostatistician were all blinded to allocations until the end of data collection.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Health Services Research, Professor of Medicine

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: June 21, 2021
• Study Start: March 23, 2022
• Primary Completion: May 12, 2024
• Study Completion: June 12, 2024
• Last Updated: March 27, 2026
• Results First Posted: June 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)