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Behavioral Intervention
Digital Behavioral Treatments for Chronic Pain
N/A
Waitlist Available
Led By Brennan Spiegel, MD, MSHS
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients who have experienced average pain intensity of >3 out of 10 within the previous week
Patients with chronic pain, using the administrative definition of ICD-10 code series G89.X or one or more of 134 chronic overlapping pain condition codes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over 12 weeks from week 1
Awards & highlights
Study Summary
This trial will compare two digital pain treatment programs to see if one is more effective than the other.
Who is the study for?
This trial is for people living in certain rural areas with chronic pain, defined by specific ICD-10 codes. They must have had an average pain intensity greater than 3 out of 10 over the past week and be at least 13 years old. Participants need to read/write English and have access to a computer or smartphone. Those with cognitive impairments, visual impairments, hospitalization, end-of-life care, or active cancer treatment cannot join.Check my eligibility
What is being tested?
The study compares two digital pain management programs: Skills-Based VR and painTRAINER®, delivered to participants' homes. Over 60 days, it will assess which program works better overall and for whom specifically by tracking functional status, pain levels, and medication use through questionnaires.See study design
What are the potential side effects?
Since this trial involves non-pharmaceutical digital treatments for managing chronic pain (Skills-Based VR & painTRAINER®), side effects are minimal but may include discomfort from prolonged use of virtual reality equipment or eye strain from screen time.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My average pain level was over 3 out of 10 last week.
Select...
I have chronic pain diagnosed under specific medical codes.
Select...
I am 13 years old or older.
Select...
My average pain level was over 3 out of 10 last week.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Daily Pain Intensity
Secondary outcome measures
Coping with Weekly Pain Questionnaire
Opioid prescriptions of Morphine Milligram Equivalents (MME)
PROMIS Pain Interference 4a
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: painTRAINER (2D mHealth intervention)Experimental Treatment1 Intervention
Participants will use one of the most widely-validated mHealth interventions for pain management called painTRAINER®, which is a standardized, 56-day program delivering skills training and Cognitive behavioral therapy (CBT)-related treatments through daily virtual experiences.
Group II: Skills-based VR TherapyExperimental Treatment1 Intervention
Participants will use the Pico G2 4K VR audio and visual head-mounted device. 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PICO G2 4k
2020
N/A
~390
Find a Location
Who is running the clinical trial?
Cedars-Sinai Medical CenterLead Sponsor
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164,557 Total Patients Enrolled
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Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My average pain level was over 3 out of 10 last week.You use opioid medications.I have chronic pain diagnosed under specific medical codes.Your ethnic background may be a factor in determining your eligibility for the study.My pain level is manageable.I am 13 years old or older.Patients who are receiving care for a terminal illness or are nearing the end of their life.You live in an area that the government considers to be rural.I have a specific type of pain condition.My cognitive condition affects my ability to participate.I am currently hospitalized.Other health conditions.The participant has a strong support system from family and friends.My average pain level was over 3 out of 10 last week.I am currently undergoing treatment for cancer.
Research Study Groups:
This trial has the following groups:- Group 1: painTRAINER (2D mHealth intervention)
- Group 2: Skills-based VR Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Chronic Pain Patient Testimony for trial: Trial Name: NCT04933474 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this study require participants to be of a certain age?
"According to the published inclusion criteria, patients aged 13 to 99 are eligible for this trial. There are 33 ongoing studies involving minors and 374 trials with elderly patients."
Answered by AI
Could I be a part of this medical experiment?
"Up to 300 patients that suffer from chronic pain will be accepted into this study. There are no age restrictions, however applicants must meet the following conditions: Be literate in English, have access to a personal computer or smartphone, live in a designated rural area as defined by FORHP data, and finally experience an average pain intensity of greater than 3/10 within the previous week. Excluded participants include those who: (1) have a condition that would interfere with use of the intervention; (2) are hospitalized; (3) receiving active cancer treatment; (4) receiving end-of-life care; or (5) have"
Answered by AI
Are new participants currently being recruited for this experiment?
"That is correct. The clinicaltrials.gov website currently has a posting for this trial which began on March 23, 2022 and was last updated on July 18, 2022. They are looking to enroll 300 people total at 1 location."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
Cedars-Sinai Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I have been searching for treatment for this pain for 3 years. I amhoping to get help with the emotional aspects of it.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How.often do I have to come in?
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Cedars-Sinai Medical Center: < 48 hours
Average response time
- < 2 Days
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