Chronic PainNCT04060875
Research Protocol for Karuna Labs Inc.: Safety and Efficacy of Virtual Reality Graded Motor Imagery for Chronic Pain
An observational study of Chronic Pain and Low Back Pain, run by Karuna Labs Inc. at 1 site in United States.
Trial summary
The purpose of this study is to investigate, in two phases: (1) the feasibility and safety of Virtual Embodiment Therapy in treating chronic pain of lower back and upper limbs and (2) the efficacy of Virtual Embodiment Therapy on chronic pain disorders of the lower back and upper limbs. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Low Back Pain, Fibromyalgia
- What is being tested?
- Karuna Labs Virtual Reality Software
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2017to 1 Jun 2021
- Phase
- Observational
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People diagnosed with chronic pain disorders of the lower back or upper limbs with a continual duration of at least 6 months
Who may be able to join
- Able to understand the English language
- Have had a chronic central pain of the lower back or upper limbs diagnosis for 3 months or longer
- Can attend sessions at the study center twice a week for 4 weeks
- Able to wear a VR HMD (head-mounted display) and move head in cervical rotation, extension, and flexion
Who cannot join
- Individuals with a history of Severe Mental Illness, including schizophrenia, bipolar disorder I or II, or PTSD
- History of susceptibility to seizures per subject's reporting
- Pregnant woman
Trial locations and contacts
1 site in 1 country.
United States1 site
Remedy Medical Group
San Francisco, California, 94102
About this study
The purpose of this study is to investigate, in two phases: (1) the feasibility and safety of Virtual Embodiment Therapy in treating chronic pain of lower back and upper limbs and (2) the efficacy of Virtual Embodiment Therapy on chronic pain disorders of the lower back and upper limbs. In phase 1, we will investigate the feasibility, safety, and side effects related to this treatment by assessing simulator sickness. In phase 2, which in contingent on successful completion of phase 1, we will assess symptoms of pain specific to the region treated, fear and avoidance behavior, and depression symptoms before and after 8 sessions of treatment with Virtual Embodiment Therapy in order to assess efficacy. This study will be single-blinded, because the participation of the clinician is necessary to ensure proper administration of the therapy, as well as to monitor in the event of adverse reactions.
Read the detailed description
This multi-site study aims to investigate the feasibility, safety, and efficacy of using embodied virtual reality graded motor imagery software to treat adults with diagnosed chronic central pain conditions in two bodily regions: chronic pain in the lower back and in the upper limbs. The research will be conducted in two phases, the second of which is contingent upon successful completion of the first. The first phase will involve piloting a novel virtual reality treatment for chronic pain to investigate feasibility and safety with a smaller number of patients (N=30 for each condition). The second phase of the research will investigate efficacy using a single-blinded randomized control study design with sham control. Chronic pain conditions of the lower back and upper limbs will be investigated separately, and power analyses have been conducted to determine optimal study size, which is N=200 for each portion.
Central pain is defined as pain that originates in the central nervous system, and is not immediately due to injury, but is possibly a delayed reaction to injury. Example conditions eligible for this study include chronic lower back pain, as well as phantom limb pain, complex regional pain syndrome, carpal tunnel syndrome, post-stroke limb pain, and repetitive strain injuries of the shoulder, arm or hand. In the pilot phase of the study, 30 subjects with chronic lower back pain and 30 subjects with chronic upper limb pain will receive 8 sessions of graded motor imagery virtual reality therapy. Contingent on the success of the pilot, defined as completion of 8 session with no adverse events, and trends indicating improvement of range of motion, pain, fear/avoidance, and depression symptoms, the randomized control trial phase of the research will proceed. In the randomized phase, subjects will be randomized into active or control conditions. Active condition subjects will receive 8 sessions of graded motor imagery in virtual reality, and control condition subjects will receive a non-embodied sham virtual reality experience. This study will investigate the safety and feasibility of this approach, as well as its effects on pain symptoms.
This product is considered a non-significant risk device, as is explained in the accompanying letter from the sponsor, Karuna Labs Inc. A request for feedback from the presubmission program of the U.S. Food and Drug Administration has additionally been submitted.
- Conditions
- Chronic Pain, Low Back Pain, Fibromyalgia, Upper Extremity Dysfunction, Complex Regional Pain Syndromes, Phantom Limb Pain
- Being tested
- Karuna Labs Virtual Reality Software
- Medical subject headings
- Chronic Pain, Low Back Pain, Fibromyalgia, Complex Regional Pain Syndromes, Phantom Limb, Arthritis, Rheumatoid, Carpal Tunnel Syndrome, Cumulative Trauma Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Karuna Labs Virtual Reality SoftwareDevice
The subjects will engage in the three therapeutic modules: laterality, motor imagery, and 'mirroring.' The decision of which module to employ will be based on the subject's readiness and comfort on a case-by-case basis. A subject visit can be expected to last 40 minutes, with enough time to complete PHQ-9, and to accustom to the virtual reality setup by playing in a non-therapeutic virtual environment should they choose to do so. Time in the virtual reality is expected to last approximately 20 minutes per session.
| Study group | Role | What they receive |
|---|---|---|
| Feasibility group | First phase group will involve piloting a novel virtual reality treatment for chronic pain to investigate feasibility and safety with a smaller number of patients Receives: Device: Karuna Labs Virtual Reality Software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Safety and feasibility
Measured: 1-2 months
Simulator Sickness Questionnaire
The questionnaire asks participants to score 16 symptoms on a four point scale (0-3). The scale measures susceptibility to nausea, general discomfort, stomach awareness, sweating, increased salivation, vertigo, burping, dizziness with eyes open, fullness of head, dizziness with eyes closed, difficulty focusing, headache, blurred vision, fatigue, and eye strain
Measured: 1-2 months
Visual Analogue Scale (VAS)
The pain Visual Analogue Scale is a unidimensional measure of pain intensity. Patients are asked to rate the intensity of their pain using a horizontal line 10 centimeters (100 mm) in length. For pain intensity, the scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale])
Measured: 1-2 months
Secondary outcomes (4)
Fear and Avoidance Beliefs Questionnaire
The Fear and Avoidance Beliefs Questionnaire is a questionnaire based on the Fear-Avoidance Model of Exaggerated Pain Perception. The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear-avoidance beliefs. There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24)
Measured: 1-2 months
OSWESTRY Disability Index Questionnaire
A patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those with low back pain. Questionnaire examines perceived level of disability in 10 everyday activities of daily living concerning the intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel.
Measured: 1-2months
Pain Catastrophizing Scale
The Pain Catastrophizing Scale is a 13 item scale, with each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time). The PCS is broken into three subscales being magnification, rumination, and helplessness. The scale was developed as a self-report measurement tool that provided a valid index of catastrophizing in clinical and non-clinical populations
Measured: 1-2 months
Patient Health Questionnaire
The Patient Health Questionnaire is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The PHQ-9 consists of 9 items of DSM-IV criteria as "0" (not at all) to "3" (nearly every day)
Measured: 1-2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start21 Sep 2017
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karuna Labs Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Trujillo, PhD, Principal investigator, Vice President of Clinical Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060875
- Sponsor's protocol ID
- SAIRB-17-0063
- Status last verified
- Jun 2021
- First submitted
- 29 Jul 2019
- Last updated
- 11 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Saby A, Alvarez A, Smolins D, Petros J, Nguyen L, Trujillo M, Aygun O. Effects of Embodiment in Virtual Reality for Treatment of Chronic Pain: Pilot Open-Label Study. JMIR Form Res. 2024 Feb 16;8:e34162. doi: 10.2196/34162.
PubMed 38363591
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Protocol for Karuna Labs Inc.: Safety and Efficacy of Virtual Reality Graded Motor Imagery for Chronic Pain
- ClinicalTrials.gov ID
- NCT04060875
- Acronym / sponsor ID
- SAIRB-17-0063
- Conditions
- Chronic Pain, Low Back Pain, Fibromyalgia, Upper Extremity Dysfunction, Complex Regional Pain Syndromes, Phantom Limb Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Karuna Labs Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 19 Aug 2019 (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.
The purpose of this study is to investigate, in two phases: (1) the feasibility and safety of Virtual Embodiment Therapy in treating chronic pain of lower back and upper limbs and (2) the efficacy of Virtual Embodiment Therapy on chronic pain disorders of the lower back and upper limbs. In phase 1, we will investigate the feasibility, safety, and side effects related to this treatment by assessing simulator sickness. In phase 2, which in contingent on successful completion of phase 1, we will assess symptoms of pain specific to the region treated, fear and avoidance behavior, and depression symptoms before and after 8 sessions of treatment with Virtual Embodiment Therapy in order to assess efficacy. This study will be single-blinded, because the participation of the clinician is necessary to ensure proper administration of the therapy, as well as to monitor in the event of adverse reactions.
Detailed description
This multi-site study aims to investigate the feasibility, safety, and efficacy of using embodied virtual reality graded motor imagery software to treat adults with diagnosed chronic central pain conditions in two bodily regions: chronic pain in the lower back and in the upper limbs. The research will be conducted in two phases, the second of which is contingent upon successful completion of the first. The first phase will involve piloting a novel virtual reality treatment for chronic pain to investigate feasibility and safety with a smaller number of patients (N=30 for each condition). The second phase of the research will investigate efficacy using a single-blinded randomized control study design with sham control. Chronic pain conditions of the lower back and upper limbs will be investigated separately, and power analyses have been conducted to determine optimal study size, which is N=200 for each portion.
Central pain is defined as pain that originates in the central nervous system, and is not immediately due to injury, but is possibly a delayed reaction to injury. Example conditions eligible for this study include chronic lower back pain, as well as phantom limb pain, complex regional pain syndrome, carpal tunnel syndrome, post-stroke limb pain, and repetitive strain injuries of the shoulder, arm or hand. In the pilot phase of the study, 30 subjects with chronic lower back pain and 30 subjects with chronic upper limb pain will receive 8 sessions of graded motor imagery virtual reality therapy. Contingent on the success of the pilot, defined as completion of 8 session with no adverse events, and trends indicating improvement of range of motion, pain, fear/avoidance, and depression symptoms, the randomized control trial phase of the research will proceed. In the randomized phase, subjects will be randomized into active or control conditions. Active condition subjects will receive 8 sessions of graded motor imagery in virtual reality, and control condition subjects will receive a non-embodied sham virtual reality experience. This study will investigate the safety and feasibility of this approach, as well as its effects on pain symptoms.
This product is considered a non-significant risk device, as is explained in the accompanying letter from the sponsor, Karuna Labs Inc. A request for feedback from the presubmission program of the U.S. Food and Drug Administration has additionally been submitted.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Feasibility group | – | Device: Karuna Labs Virtual Reality SoftwareFirst phase group will involve piloting a novel virtual reality treatment for chronic pain to investigate feasibility and safety with a smaller number of patients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People diagnosed with chronic pain disorders of the lower back or upper limbs with a continual duration of at least 6 months
Key inclusion criteria (4 listed)
- Able to understand the English language
- Have had a chronic central pain of the lower back or upper limbs diagnosis for 3 months or longer
- Can attend sessions at the study center twice a week for 4 weeks
- Able to wear a VR HMD (head-mounted display) and move head in cervical rotation, extension, and flexion
Key exclusion criteria (3 listed)
- Individuals with a history of Severe Mental Illness, including schizophrenia, bipolar disorder I or II, or PTSD
- History of susceptibility to seizures per subject's reporting
- Pregnant woman
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 |
|---|---|---|
| Karuna Labs Virtual Reality SoftwareThe subjects will engage in the three therapeutic modules: laterality, motor imagery, and 'mirroring.' The decision of which module to employ will be based on the subject's readiness and comfort on a case-by-case basis. A subject visit can be expected to last 40 minutes, with enough time to complete PHQ-9, and to accustom to the virtual reality setup by playing in a non-therapeutic virtual environment should they choose to do so. Time in the virtual reality is expected to last approximately 20 minutes per session. | Device | Feasibility group |
Primary outcome
Adverse events
Time frame: 1-2 months
Safety and feasibility
Simulator Sickness Questionnaire
Time frame: 1-2 months
The questionnaire asks participants to score 16 symptoms on a four point scale (0-3). The scale measures susceptibility to nausea, general discomfort, stomach awareness, sweating, increased salivation, vertigo, burping, dizziness with eyes open, fullness of head, dizziness with eyes closed, difficulty focusing, headache, blurred vision, fatigue, and eye strain
Visual Analogue Scale (VAS)
Time frame: 1-2 months
The pain Visual Analogue Scale is a unidimensional measure of pain intensity. Patients are asked to rate the intensity of their pain using a horizontal line 10 centimeters (100 mm) in length. For pain intensity, the scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale])
4 secondary outcomes
Fear and Avoidance Beliefs Questionnaire
Time frame: 1-2 months
OSWESTRY Disability Index Questionnaire
Time frame: 1-2months
Pain Catastrophizing Scale
Time frame: 1-2 months
Patient Health Questionnaire
Time frame: 1-2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Derived from this study: PubMed 38363591Saby A, Alvarez A, Smolins D, Petros J, Nguyen L, Trujillo M, Aygun O. Effects of Embodiment in Virtual Reality for Treatment of Chronic Pain: Pilot Open-Label Study. JMIR Form Res. 2024 Feb 16;8:e34162. doi: 10.2196/34162.
- Individual participant dataSharing planned: Undecided
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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 Trujillo, PhD principal investigator
Vice President of Clinical Affairs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Low Back Pain, run by Karuna Labs Inc. 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 11 Jun 2021. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse events (time frame: 1-2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04060875, which also lists 1 linked publication.
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 11 Jun 2021.