Back Pain Lower Back ChronicVRNCT04273919
Virtual Reality for the Treatment of Chronic Low Back Pain
A study testing HTC Vive with Karuna Virtual Reality Program and HTC Vive with Lumen Program in people with Back Pain Lower Back Chronic, run by University of Pennsylvania at 1 site in United States.
Trial summary
Chronic low back pain is highly prevalent in US adults and is a major cause of missed work days and disability. While several treatment options exist, chronic opioids are commonly used for these conditions even though there are limited data supporting efficacy, and clear evidence of harm associated with chronic opioid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Back Pain Lower Back Chronic
- What is being tested?
- HTC Vive with Karuna Virtual Reality Program and HTC Vive with Lumen Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18
- Able to speak and read English
- A history of chronic low back pain for at least 6 months
- No changes to medications within 30 days of randomization
- Able to provide outcomes data through the electronic patient-reported outcome data collection system
Who cannot join
- Age less than 18 years.
- Pregnant women
- Cognitive impairment that limits ability to participate in the study, including the provision of outcome data through the electronic patient-reported outcome data collection system.
- Unable to stand for at least 15 minutes
- Employees or students of the University of Pennsylvania
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn Pain Medicine Center
Philadelphia, Pennsylvania, 19146
About this study
Official title: A Pilot Study to Evaluate the Safety and Efficacy of the Karuna Virtual Reality Program for the Treatment of Chronic Low Back Pain
Chronic low back pain is highly prevalent in US adults and is a major cause of missed work days and disability. While several treatment options exist, chronic opioids are commonly used for these conditions even though there are limited data supporting efficacy, and clear evidence of harm associated with chronic opioid administration.
Virtual reality has been proposed as a treatment option that may lead to decreased pain and improved physical functioning, while avoiding the harms associated with medication management. This study is intended to obtain preliminary safety and efficacy data to guide the design of a larger clinical trial.
Read the detailed description
This is a pilot study to evaluate the safety and efficacy of the Kauruna Virtual Reality program for the treatment of chronic low back pain. This study is intended to document the safety and efficacy of the use of virtual reality for the treatment of chronic low back pain. The primary outcome measure will be physical functioning as measured by the PROMIS 6. Secondary outcome measures include patient-reported pain intensity, adverse side effects, disability as measured by the Oswestry Low back disability questionnaire, and mental functioning as assessed using the PHQ-9 and GAD-7. Finally, impact on opioid use in patients on chronic opioids will be assessed by documentation of daily opioid dose in oral morphine equivalents.
Forty adult patients with chronic low back pain who are receiving care through the Penn Pain Medicine Center are eligible to participate in the study. The study will consist of a screening visit, followed by randomization into 1 of 2 study groups. Both study groups will participate in two 20-minute virtual reality sessions a week for 8 weeks. Study group 1 will participate in 20 minutes of mindfulness mediation. Study Group 2 will undergo initial sessions focused on graded motor imagery, followed by sessions focused on graded exposure. Patient-reported outcomes data will be obtained at baseline, then weekly during the 8-week study period, then 4 weeks following completion of the study sessions.
- Conditions
- Back Pain Lower Back Chronic
- Being tested
- HTC Vive with Karuna Virtual Reality Program, HTC Vive with Lumen Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTC Vive with Karuna Virtual Reality ProgramDevice
HTC Vive head-mounted display and an HTC Vive body tracker adhered to a belt on the patient's low back, which will be placed 2 inches below the waist
HTC Vive with Lumen ProgramDevice
HTC Vive head-mounted display with Lumen program
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Mediation | Sham comparator | Subjects will undergo virtual reality in a non-embodied (no first person bodily experience) program called Lumen, which was developed by Stanford University's Virtual Human Interaction Lab. Receives: Device: HTC Vive with Lumen Program |
| Graded Motor Imagery | Experimental | The subjects will engage in 2 therapeutic modules intended to help them practice increasing range of motion safely, and using small movements of the lower back. Receives: Device: HTC Vive with Karuna Virtual Reality Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Functioning measured by PROMIS 6 (Patient Reported Outcome Measurement Information System)
Physical functioning reported on a scale 1 (unable to do) to 5 (without any difficulty)
Measured: 12 weeks
Secondary outcomes (5)
Patient-Reported Pain Intensity
Pain reported on a scale 0 (no pain) to 10 (worst pain possible)
Measured: 12 weeks
Disability measured by the Oswestry Low Back Disability Questionnaire
Disability reported on a scale 0 (can complete task) to 5 (can't complete tasks)
Measured: 12 weeks
Mental Functioning measured by PHQ-9 (Patient Health Questionnaire)
Mental functioning reported on a scale 0 (not at all) to 3 (nearly every day)
Measured: 12 weeks
Mental Functioning measured by GAD-7 (Generalized Anxiety Disorder)
Mental functioning reported on a scale 0 (not at all) to 3 (nearly every day)
Measured: 12 weeks
Adverse Events
Any symptom, sign, illness or experience that develops or worsens in severity during the course of the study will be documented
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start1 Aug 2020
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Why it stopped: Due to the impact of COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back Pain Lower Back ChronicStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Ashburn, MD, MPH, University of Pennsylvania
- Investigators
- Michael A Ashburn, MD, MPH, Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273919
- Sponsor's protocol ID
- 834277
- Acronym
- VR
- Status last verified
- Mar 2023
- First submitted
- 4 Feb 2020
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not applicable. Insufficient data collected. Study closed prematurely.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Safety and Efficacy of the Karuna Virtual Reality Program for the Treatment of Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT04273919
- Acronym / sponsor ID
- VR / 834277
- Conditions
- Back Pain Lower Back Chronic
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to the impact of COVID-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 18 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic low back pain is highly prevalent in US adults and is a major cause of missed work days and disability. While several treatment options exist, chronic opioids are commonly used for these conditions even though there are limited data supporting efficacy, and clear evidence of harm associated with chronic opioid administration.
Virtual reality has been proposed as a treatment option that may lead to decreased pain and improved physical functioning, while avoiding the harms associated with medication management. This study is intended to obtain preliminary safety and efficacy data to guide the design of a larger clinical trial.
Detailed description
This is a pilot study to evaluate the safety and efficacy of the Kauruna Virtual Reality program for the treatment of chronic low back pain. This study is intended to document the safety and efficacy of the use of virtual reality for the treatment of chronic low back pain. The primary outcome measure will be physical functioning as measured by the PROMIS 6. Secondary outcome measures include patient-reported pain intensity, adverse side effects, disability as measured by the Oswestry Low back disability questionnaire, and mental functioning as assessed using the PHQ-9 and GAD-7. Finally, impact on opioid use in patients on chronic opioids will be assessed by documentation of daily opioid dose in oral morphine equivalents.
Forty adult patients with chronic low back pain who are receiving care through the Penn Pain Medicine Center are eligible to participate in the study. The study will consist of a screening visit, followed by randomization into 1 of 2 study groups. Both study groups will participate in two 20-minute virtual reality sessions a week for 8 weeks. Study group 1 will participate in 20 minutes of mindfulness mediation. Study Group 2 will undergo initial sessions focused on graded motor imagery, followed by sessions focused on graded exposure. Patient-reported outcomes data will be obtained at baseline, then weekly during the 8-week study period, then 4 weeks following completion of the study sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Mediation | Sham comparator | Device: HTC Vive with Lumen ProgramSubjects will undergo virtual reality in a non-embodied (no first person bodily experience) program called Lumen, which was developed by Stanford University's Virtual Human Interaction Lab. |
| Graded Motor Imagery | Experimental | Device: HTC Vive with Karuna Virtual Reality ProgramThe subjects will engage in 2 therapeutic modules intended to help them practice increasing range of motion safely, and using small movements of the lower back. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age over 18
- Able to speak and read English
- A history of chronic low back pain for at least 6 months
- No changes to medications within 30 days of randomization
- Able to provide outcomes data through the electronic patient-reported outcome data collection system
Key exclusion criteria (5 listed)
- Age less than 18 years.
- Pregnant women
- Cognitive impairment that limits ability to participate in the study, including the provision of outcome data through the electronic patient-reported outcome data collection system.
- Unable to stand for at least 15 minutes
- Employees or students of the University of Pennsylvania
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HTC Vive with Karuna Virtual Reality ProgramHTC Vive head-mounted display and an HTC Vive body tracker adhered to a belt on the patient's low back, which will be placed 2 inches below the waist | Device | Graded Motor Imagery |
| HTC Vive with Lumen ProgramHTC Vive head-mounted display with Lumen program | Device | Mindfulness Mediation |
Primary outcome
Physical Functioning measured by PROMIS 6 (Patient Reported Outcome Measurement Information System)
Time frame: 12 weeks
Physical functioning reported on a scale 1 (unable to do) to 5 (without any difficulty)
5 secondary outcomes
Patient-Reported Pain Intensity
Time frame: 12 weeks
Disability measured by the Oswestry Low Back Disability Questionnaire
Time frame: 12 weeks
Mental Functioning measured by PHQ-9 (Patient Health Questionnaire)
Time frame: 12 weeks
Mental Functioning measured by GAD-7 (Generalized Anxiety Disorder)
Time frame: 12 weeks
Adverse Events
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Karuna Labs FDA Establishment RegistrationLink provided by the sponsor.
- Individual participant dataSharing planned: No. Not applicable. Insufficient data collected. Study closed prematurely.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A Ashburn, MD, MPH principal investigator
Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HTC Vive with Karuna Virtual Reality Program and HTC Vive with Lumen Program in people with Back Pain Lower Back Chronic, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Functioning measured by PROMIS 6 (Patient Reported Outcome Measurement Information System) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.