Chronic Low-back PainAVR_HEORNCT05263037
EaseVRx-8w+ for the Treatment of Chronic Lower Back Pain
A study testing EaseVRx in people with Chronic Low-back Pain and Anxiety, run by AppliedVR Inc. at 1 site in United States.
Trial summary
The aim of this randomized controlled trial (RCT) is to assess outcomes for virtual reality therapy (including pain intensity, pain interference, anxiety, depression, physical function, sleep, behavioral skills development, health outcomes and satisfaction) along with healthcare utilization and costs in participants… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Low-back Pain, Anxiety, Depression
- What is being tested?
- EaseVRx
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,093 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2022to Jun 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female adults aged 18-85.
- Self-reported chronic low back pain that will be confirmed with claims data when available.
- Pain duration of at least three months.
- Average pain intensity score of ≥ 4 and average pain interference score of ≥ 4 on the 0-10 Brief Pain Inventory (BPI) Pain Scale for the past month at screening.
- Fluency in English.
- Willing and able to comply with all study procedures including all required restrictions for the duration of study participation.
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- Able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study.
- Access to Internet for the duration of their study participation (24 months).
- Access to a smartphone or computer for the duration of the study.
- Availability of a physical mailing address that is not a PO box address for receipt of the device.
- Completed the Baseline Survey plus at least two of the five sets of participant surveys that are administered during the 10-day pretreatment assessment period.
- Able to provide photo ID
Who cannot join
- Unable to understand the goals of the study due to cognitive difficulty.
- Any medical condition that may prevent the use of virtual reality (e.g., current, or prior diagnosis of epilepsy, seizure disorder, hypersensitivity to flashing light or motion, migraines, any medical condition predisposing participant to nausea or dizziness, dementia, absence of stereoscopic vision or severe hearing impairment).
- Injury to eyes, face, or neck that prevents comfortable use of VR.
- Index back pain is linked to a cancer-related diagnosis.
- Possible suicidal ideation as indicated by the 9th item of the Participant Health Questionnaire-9 (PHQ-9).
- Previous participation in the 2020 AVR EaseVRx pivotal study.
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- Receiving worker's compensation and/or involved in any active litigation related to an injury.
- Current or recent participation (i.e., within the last 2 months) in any other research study involving a drug, device, vaccine, or other interventional treatment product; or plans to participate in another research study over the next 24 months.
- Participation of two or more members in one household
- Recent or future medical procedures scheduled related to any current diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Decentralized, Randomized, Controlled Trial to Study Health Outcomes of EaseVRx-8w+ for the Treatment of Chronic Lower Back Pain
The aim of this randomized controlled trial (RCT) is to assess outcomes for virtual reality therapy (including pain intensity, pain interference, anxiety, depression, physical function, sleep, behavioral skills development, health outcomes and satisfaction) along with healthcare utilization and costs in participants with Chronic Low Back Pain.
Read the detailed description
This is a decentralized, randomized controlled trial with four parallel study arms comparing change from pre-treatment to end-of-treatment to 12-months posttreatment in the EaseVRx-8w, EaseVRx-8w plus extended on-demand and Control groups. After consenting to join the study, participants will be randomized and allocated to one of four treatment programs. Study devices will be delivered to the participant's home with instructions for use via FedEx with complementary remote technical support.
- participants in the EaseVRx-8w arm will participate in an 8-week interventional program and continue to be followed for 24 months after completion of treatment
- participants in the EaseVRx-8w plus extended on-demand arm will enroll in an 8-week interventional program and be offered an extended 8-week ondemand period, and continue to be followed for 24 months after the completion of treatment.• participants in the first control arm will receive 2D Sham VR virtual reality content during the 8-week interventional program and continue to be followed for 24 months after the completion of treatment
- participants in the second control arm will receive 2D Sham VR virtual reality content during the 8-week interventional program and be offered an extended 8-week on-demand period, after which they will continue to be followed for 24 months after the completion of treatment All trial participants will be monitored for pain intensity and pain interference, physical function, behavioral skills development, health outcomes and satisfaction.
Additionally, to assess resource use associated with CLBP, participant data will be run through a secure Datavant matching process to be linked to their healthcare claims data if it is available in the Komodo data set. The claims will provide descriptive characterizations of resource use and healthcare costs associated with CLBP. For participant-level changes in resource use, and for comparisons between study arms, only the participants with complete claims files will be assessed. Claims matched data will capture all interactions with the healthcare system that generate an insurance claim record, which includes such things as physician visits, interventions such as steroid injections, surgery or physical therapy, emergent use of services, medications, and diagnostic procedures. Claims adjudication often lags a few months, so the most robust analyses of utilization will be performed about 6 months after the time point of interest. Health economic modeling will be performed after 1 year to assess the cost and economic outcomes of the EaseVRx intervention.
- Conditions
- Chronic Low-back Pain, Anxiety, Depression
- Being tested
- EaseVRx, Sham VR
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EaseVRxDevice
Also called Skills based EaseVR
VR software with interactive content
Sham VRDevice
VR with neutral non-interactive content
| Study group | Role | What they receive |
|---|---|---|
| 56-day skills-based VR program | Experimental | participants in the EaseVRx-8w arm will participate in an 8-week interventional program and continue to be followed for 24 months following completion of tx Receives: Device: EaseVRx |
| 56-day skills-based VR program followed by an extended 56-day on-demand period | Experimental | participants in the EaseVRx-8w plus extended on-demand arm will enroll in an 8-week interventional program and be offered an extended 8-week ondemand period, and continue to be followed for 24 months after the completion of treatment Receives: Device: EaseVRx |
| 56-day control (Sham VR) | Sham comparator | participants in the first control arm will receive 2D Sham VR virtual reality content during the 8-week interventional program and continue to be followed for 24 months after the completion of treatment. participants in the Sham VR group will receive the same Pico G2 4K headset as participants in the immersive VR groups, but rather than view 360-degree, 3D, interactive content specially selected for efficacy, they will only have access to 2D nature footage with neutral music layered on top that is selected to be neither overly relaxing nor distracting. The experience of Sham VR is similar to watching a large-screen TV, but it is not interactive. The advantage of Sham VR is that it controls for the novelty and immersion of the hardware and isolates the effect of VR skill-based training Receives: Device: Sham VR |
| • 56-day control (Sham VR plus 8w extended on-demand) | Sham comparator | participants in the second control arm will receive 2D Sham VR virtual reality content during the 8-week interventional program and be offered an extended 8-week on-demand period, after which they will continue to be followed for 24 months after the completion of treatment.Participants in the Sham VR group will receive the same Pico G2 4K headset as participants in the immersive VR groups, but rather than view 360-degree, 3D, interactive content specially selected for efficacy, they will only have access to 2D nature footage with neutral music layered on top that is selected to be neither overly relaxing nor distracting. Receives: Device: Sham VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory (BPI) Pain Intensity Questionnaire
The BPI pain intensity questionnaire is a validated instrument with good content validity, construct validity, and reliability in participants with chronic pain. The range of scores are from 0-10 with higher values implying greater pain intensity. The BPI pain intensity measure contains a single item related to pain intensity
Measured: Day 56 (end of treatment)
Secondary outcomes (4)
Oswestry Disability Index Score (ODI v2.1b)
The ODI questionnaire is a validated instrument with good content validity, construct validity, and reliability in participants with chronic pain. The metric includes 10 items that are summed with a score ranging from 0 - 100%. The higher the score the greater the impact of chronic pain on the participant.
Measured: The outcome measure is administered at baseline, day 56 (end of treatment), and 1, 2, 3, 6, 12, 18, 24 months post treatment. Anticipated reporting date June 2027
PROMIS Sleep Disturbance
The PROMIS Sleep disturbance questionnaire is a validated instrument with good content validity, construct validity, and reliability in participants with chronic pain. The metric includes 8 items that are summed with a raw score range from 0 - 40. The higher the score the worse sleep.
Measured: The outcome measure is administered at baseline, day 56 (end of treatment), and 1, 2, 3, 6, 12, 18, 24 months post treatment
PROMIS Depression
The PROMIS Depression questionnaire is a validated instrument with good content validity, construct validity, and reliability in participants with chronic pain. The metric includes 8 items that are summed with a raw score range from 0 - 40. The higher the score the worse depression.
Measured: The outcome measure is administered at baseline, day 56 (end of treatment), and 1, 2, 3, 6, 12, 18, 24 months post treatment
PROMIS Anxiety
The PROMIS Anxiety questionnaire is a validated instrument with good content validity, construct validity, and reliability in participants with chronic pain. The metric includes 7 items that are summed with a raw score range from 0 - 35. The higher the score the worse anxiety.
Measured: The outcome measure is administered at baseline, day 56 (end of treatment), and 1, 2, 3, 6, 12, 18, 24 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start31 Jan 2022
- Primary completion13 Oct 2022
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Enrolled participants will be randomized 1:1:1:1 and assigned to one of four treatment arms: * 56-day skills-based VR program (EaseVRx-8w) * 56-day skills-based VR program followed by an extended 56-day on-demand period (EaseVRx-8w plus extended on-demand) * 56-day control (Sham VR) * 56-day control followed by an extended 56-day on-demand period (Sham VR plus 8w extended on-demand)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,093 participants (actual)
Sponsor and investigators
- Lead sponsor
- AppliedVR Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Todd Maddox, AppliedVR Inc.
- Investigators
- Todd Maddox, Ph.D., Principal investigator, AppliedVR Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263037
- Sponsor's protocol ID
- EaseVRx HEOR 2021
- Acronym
- AVR_HEOR
- Status last verified
- Jan 2025
- First submitted
- 31 Jan 2022
- Last updated
- 29 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Maddox T, Oldstone L, Sackman J, Judge E, Maddox R, Adair T, Ffrench K, Sparks CY, Darnall BD. Sociodemographic Predictors of Clinical Effectiveness, Therapeutic Program Engagement, and Device Usability for an In-Home Virtual Reality Program for Chronic Low Back Pain: Secondary Analysis of a Randomized Controlled Trial. J Med Ext Real. 2024 Apr 18;1(1):65-72. doi: 10.1089/jmxr.2023.0013. eCollection 2024.
PubMed 42558092Maddox T, Sackman J, Judge E, Maddox R, Bonakdar R, Darnall BD. From randomized controlled trial to real world clinical evidence: effectiveness and engagement of in-home virtual reality pain treatment for chronic pain in older adults. Front Pain Res (Lausanne). 2025 Dec 10;6:1694007. doi: 10.3389/fpain.2025.1694007. eCollection 2025.
PubMed 41450975Maddox T, Oldstone L, Linde-Zwirble W, Bonakdar R, Maddox R, Sackman J, Adair T, Ffrench K, Sparks C, Darnall BD. Differential treatment response to virtual reality in high-impact chronic pain: secondary analysis of a randomized trial. Sci Rep. 2025 Apr 25;15(1):14430. doi: 10.1038/s41598-025-98716-3.
PubMed 40281004Maddox T, Oldstone L, Sparks CY, Sackman J, Oyao A, Garcia L, Maddox RU, Ffrench K, Garcia H, Adair T, Irvin A, Maislin D, Keenan B, Bonakdar R, Darnall BD. In-Home Virtual Reality Program for Chronic Lower Back Pain: A Randomized Sham-Controlled Effectiveness Trial in a Clinically Severe and Diverse Sample. Mayo Clin Proc Digit Health. 2023 Oct 24;1(4):563-573. doi: 10.1016/j.mcpdig.2023.09.003. eCollection 2023 Dec.
PubMed 40206316
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Decentralized, Randomized, Controlled Trial to Study Health Outcomes of EaseVRx-8w+ for the Treatment of Chronic Lower Back Pain
- ClinicalTrials.gov ID
- NCT05263037
- Acronym / sponsor ID
- AVR_HEOR / EaseVRx HEOR 2021
- Conditions
- Chronic Low-back Pain, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,093 participants (actual)
- Lead sponsor
- AppliedVR Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 13 Oct 2022 (actual)
- Study completion
- Jun 2026 (estimated)
- First posted
- 2 Mar 2022 (actual)
- Results
- Posted 20 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this randomized controlled trial (RCT) is to assess outcomes for virtual reality therapy (including pain intensity, pain interference, anxiety, depression, physical function, sleep, behavioral skills development, health outcomes and satisfaction) along with healthcare utilization and costs in participants with Chronic Low Back Pain.
Detailed description
This is a decentralized, randomized controlled trial with four parallel study arms comparing change from pre-treatment to end-of-treatment to 12-months posttreatment in the EaseVRx-8w, EaseVRx-8w plus extended on-demand and Control groups. After consenting to join the study, participants will be randomized and allocated to one of four treatment programs. Study devices will be delivered to the participant's home with instructions for use via FedEx with complementary remote technical support.
- participants in the EaseVRx-8w arm will participate in an 8-week interventional program and continue to be followed for 24 months after completion of treatment
- participants in the EaseVRx-8w plus extended on-demand arm will enroll in an 8-week interventional program and be offered an extended 8-week ondemand period, and continue to be followed for 24 months after the completion of treatment.• participants in the first control arm will receive 2D Sham VR virtual reality content during the 8-week interventional program and continue to be followed for 24 months after the completion of treatment
- participants in the second control arm will receive 2D Sham VR virtual reality content during the 8-week interventional program and be offered an extended 8-week on-demand period, after which they will continue to be followed for 24 months after the completion of treatment All trial participants will be monitored for pain intensity and pain interference, physical function, behavioral skills development, health outcomes and satisfaction.
Additionally, to assess resource use associated with CLBP, participant data will be run through a secure Datavant matching process to be linked to their healthcare claims data if it is available in the Komodo data set. The claims will provide descriptive characterizations of resource use and healthcare costs associated with CLBP. For participant-level changes in resource use, and for comparisons between study arms, only the participants with complete claims files will be assessed. Claims matched data will capture all interactions with the healthcare system that generate an insurance claim record, which includes such things as physician visits, interventions such as steroid injections, surgery or physical therapy, emergent use of services, medications, and diagnostic procedures. Claims adjudication often lags a few months, so the most robust analyses of utilization will be performed about 6 months after the time point of interest. Health economic modeling will be performed after 1 year to assess the cost and economic outcomes of the EaseVRx intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Enrolled participants will be randomized 1:1:1:1 and assigned to one of four treatment arms: * 56-day skills-based VR program (EaseVRx-8w) * 56-day skills-based VR program followed by an extended 56-day on-demand period (EaseVRx-8w plus extended on-demand) * 56-day control (Sham VR) * 56-day control followed by an extended 56-day on-demand period (Sham VR plus 8w extended on-demand)
| Arm | Type | Receives |
|---|---|---|
| 56-day skills-based VR program | Experimental | Device: EaseVRxparticipants in the EaseVRx-8w arm will participate in an 8-week interventional program and continue to be followed for 24 months following completion of tx |
| 56-day skills-based VR program followed by an extended 56-day on-demand period | Experimental | Device: EaseVRxparticipants in the EaseVRx-8w plus extended on-demand arm will enroll in an 8-week interventional program and be offered an extended 8-week ondemand period, and continue to be followed for 24 months after the completion of treatment |
| 56-day control (Sham VR) | Sham comparator | Device: Sham VRparticipants in the first control arm will receive 2D Sham VR virtual reality content during the 8-week interventional program and continue to be followed for 24 months after the completion of treatment. participants in the Sham VR group will receive the same Pico G2 4K headset as participants in the immersive VR groups, but rather than view 360-degree, 3D, interactive content specially selected for efficacy, they will only have access to 2D nature footage with neutral music layered on top that is selected to be neither overly relaxing nor distracting. The experience of Sham VR is similar to watching a large-screen TV, but it is not interactive. The advantage of Sham VR is that it controls for the novelty and immersion of the hardware and isolates the effect of VR skill-based training |
| • 56-day control (Sham VR plus 8w extended on-demand) | Sham comparator | Device: Sham VRparticipants in the second control arm will receive 2D Sham VR virtual reality content during the 8-week interventional program and be offered an extended 8-week on-demand period, after which they will continue to be followed for 24 months after the completion of treatment.Participants in the Sham VR group will receive the same Pico G2 4K headset as participants in the immersive VR groups, but rather than view 360-degree, 3D, interactive content specially selected for efficacy, they will only have access to 2D nature footage with neutral music layered on top that is selected to be neither overly relaxing nor distracting. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male and female adults aged 18-85.
- Self-reported chronic low back pain that will be confirmed with claims data when available.
- Pain duration of at least three months.
- Average pain intensity score of ≥ 4 and average pain interference score of ≥ 4 on the 0-10 Brief Pain Inventory (BPI) Pain Scale for the past month at screening.
- Fluency in English.
Key exclusion criteria (10 listed)
- Unable to understand the goals of the study due to cognitive difficulty.
- Any medical condition that may prevent the use of virtual reality (e.g., current, or prior diagnosis of epilepsy, seizure disorder, hypersensitivity to flashing light or motion, migraines, any medical condition predisposing participant to nausea or dizziness, dementia, absence of stereoscopic vision or severe hearing impairment).
- Injury to eyes, face, or neck that prevents comfortable use of VR.
- Index back pain is linked to a cancer-related diagnosis.
- Possible suicidal ideation as indicated by the 9th item of the Participant Health Questionnaire-9 (PHQ-9).
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 |
|---|---|---|
| EaseVRxAlso: Skills based EaseVRVR software with interactive content | Device | 56-day skills-based VR program, 56-day skills-based VR program followed by an extended 56-day on-demand period |
| Sham VRVR with neutral non-interactive content | Device | 56-day control (Sham VR), • 56-day control (Sham VR plus 8w extended on-demand) |
Primary outcome
Brief Pain Inventory (BPI) Pain Intensity Questionnaire
Time frame: Day 56 (end of treatment)
The BPI pain intensity questionnaire is a validated instrument with good content validity, construct validity, and reliability in participants with chronic pain. The range of scores are from 0-10 with higher values implying greater pain intensity. The BPI pain intensity measure contains a single item related to pain intensity
4 secondary outcomes
Oswestry Disability Index Score (ODI v2.1b)
Time frame: The outcome measure is administered at baseline, day 56 (end of treatment), and 1, 2, 3, 6, 12, 18, 24 months post treatment. Anticipated reporting date June 2027
PROMIS Sleep Disturbance
Time frame: The outcome measure is administered at baseline, day 56 (end of treatment), and 1, 2, 3, 6, 12, 18, 24 months post treatment
PROMIS Depression
Time frame: The outcome measure is administered at baseline, day 56 (end of treatment), and 1, 2, 3, 6, 12, 18, 24 months post treatment
PROMIS Anxiety
Time frame: The outcome measure is administered at baseline, day 56 (end of treatment), and 1, 2, 3, 6, 12, 18, 24 months post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42558092Maddox T, Oldstone L, Sackman J, Judge E, Maddox R, Adair T, Ffrench K, Sparks CY, Darnall BD. Sociodemographic Predictors of Clinical Effectiveness, Therapeutic Program Engagement, and Device Usability for an In-Home Virtual Reality Program for Chronic Low Back Pain: Secondary Analysis of a Randomized Controlled Trial. J Med Ext Real. 2024 Apr 18;1(1):65-72. doi: 10.1089/jmxr.2023.0013. eCollection 2024.
- Derived from this study: PubMed 41450975Maddox T, Sackman J, Judge E, Maddox R, Bonakdar R, Darnall BD. From randomized controlled trial to real world clinical evidence: effectiveness and engagement of in-home virtual reality pain treatment for chronic pain in older adults. Front Pain Res (Lausanne). 2025 Dec 10;6:1694007. doi: 10.3389/fpain.2025.1694007. eCollection 2025.
- Derived from this study: PubMed 40281004Maddox T, Oldstone L, Linde-Zwirble W, Bonakdar R, Maddox R, Sackman J, Adair T, Ffrench K, Sparks C, Darnall BD. Differential treatment response to virtual reality in high-impact chronic pain: secondary analysis of a randomized trial. Sci Rep. 2025 Apr 25;15(1):14430. doi: 10.1038/s41598-025-98716-3.
- Derived from this study: PubMed 40206316Maddox T, Oldstone L, Sparks CY, Sackman J, Oyao A, Garcia L, Maddox RU, Ffrench K, Garcia H, Adair T, Irvin A, Maislin D, Keenan B, Bonakdar R, Darnall BD. In-Home Virtual Reality Program for Chronic Lower Back Pain: A Randomized Sham-Controlled Effectiveness Trial in a Clinically Severe and Diverse Sample. Mayo Clin Proc Digit Health. 2023 Oct 24;1(4):563-573. doi: 10.1016/j.mcpdig.2023.09.003. eCollection 2023 Dec.
- Individual participant dataSharing planned: No
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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.
Todd Maddox, Ph.D. principal investigator
AppliedVR Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EaseVRx in people with Chronic Low-back Pain and Anxiety, run by AppliedVR 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 12 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 29 Jan 2025. 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?
Yes. Results are posted in the registry (first posted 20 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Brief Pain Inventory (BPI) Pain Intensity Questionnaire (time frame: Day 56 (end of treatment)). 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 NCT05263037, which also lists 4 linked publications.
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 29 Jan 2025.