N/A
N=330
Pragmatic Comparative Effectiveness Trial of Evidence-based, On-demand, Digital Behavioral Treatments for Chronic Pain
Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT04933474 ↗Enrolled (actual)
330
Serious AEs
2.1%
Results posted
Jun 2025
Primary outcome: Primary: Change From Baseline to Week 8 in Daily Pain Intensity — 85; 118; 40; 35 Participants — p=0.088
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- painTRAINER® (Behavioral); Skills-Based VR (Device)
- Age
- Pediatric, Adult, Older Adult · 13+ yrs
- Sex
- All
- Sponsor
- Cedars-Sinai Medical Center
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 8 in Daily Pain Intensity |
85; 118; 40; 35 | 0.088 |
| SECONDARY Change in Patient-Reported Outcomes Measurement Information System Pain Interference 4a (PROMIS-PI) T-score |
-4.5; -3.2 | 0.103 |
| SECONDARY Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety T-score |
-0.3; -0.6 | 0.774 |
| SECONDARY Change in 2-item Pain Self-Efficacy Questionnaire (PSEQ-2) |
1.5; 0.6 | 0.005 sig |
| SECONDARY Change in 4-item Pain Catastrophizing Scale (briefPCS) |
-1.8; -1.7 | 0.831 |
| SECONDARY Change in Weekly Opioid Use (Use or No Use) |
67; 67; 44; 45 | 0.031 sig |
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT04933474). 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.