Pain, ChronicPROGRESSNCT05612750
Comparative Effectiveness of Online 8-session CBT vs. 1-Session Empowered Relief for Chronic Pain - The PROGRESS Study
A study testing Cognitive Behavioral Therapy (CBT) and Empowered Relief in people with Pain, Chronic and Lupus, run by Stanford University at 5 sites in United States.
Trial summary
The purpose of this study is to conduct a pragmatic clinical trial comparing the effectiveness of: (1) 8-week cognitive behavioral therapy for chronic pain (pain-CBT; sixteen hours total treatment time); and (2) a 1-session pain relief skills intervention for chronic pain (Empowered Relief; two hours total treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic, Lupus, Pelvic Pain
- What is being tested?
- Cognitive Behavioral Therapy (CBT) and Empowered Relief
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,650 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Jan 2023to 1 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- At least 18 years of age or older of either sex (and all genders).
- Chronic pain (pain that occurs on at least half of the days of 3 months or more).
- Past-month average pain intensity score of at least 3/10.
- Ability to adhere to and complete study protocols.
Who cannot join
- Inability to provide informed consent.
- Cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material and/or full participation in the study including group treatment.
- Active suicidality documented in medical records.
- Study staff may exclude individuals with a known history of disruptive behavior to minimize contamination of the learning environment for an entire treatment cohort.
- Receipt of either study treatment in the past 3 months.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
Elizabeth Heggan, BS, elizabeth_a.heggan@lvhn.org
Steve Denton, LCSW
- Recruiting
SCAN Health Plan
Long Beach, California, 90806
Gabby Riazi, MPH, (562) 308-5880 ext. 5880, g.riazi@scanhealthplan.com
Gabrielle Riazi, MPH
- Not yet recruiting
Humana
Louisville, Kentucky, 40202
Arayam Hailu, BS, 650-887-4497, arayamyh@stanford.edu
Jackie Miefert, MS
- Not yet recruiting
Phoenix VA Health Care System
Phoenix, Arizona, 85012
Ken Cook, CCRC, 602.277.5551 ext. 2451, arthur.cook@va.gov
Aram Mardian, MD
- Recruiting
Intermountain Healthcare
Salt Lake City, Utah, 84103
Anne Haroldsen
Joel Porter, MD
About this study
Official title: Comparative Effectiveness of Online Cognitive Behavioral Therapy vs. An Online Single-Session Pain Relief Skills Class for Chronic Pain - The PROGRESS Study
The purpose of this study is to conduct a pragmatic clinical trial comparing the effectiveness of: (1) 8-week cognitive behavioral therapy for chronic pain (pain-CBT; sixteen hours total treatment time); and (2) a 1-session pain relief skills intervention for chronic pain (Empowered Relief; two hours total treatment time).
Read the detailed description
The purpose of this study is to conduct a pragmatic clinical trial comparing the effectiveness: (1) 8-session cognitive behavioral therapy for chronic pain (pain-CBT); and (2) a 1-session pain relief skills intervention for chronic pain (Empowered Relief). The investigators aim to understand for patients which treatment works best.
Online evidence-based behavioral treatment for pain will greatly expand access to patients across the U.S. living with diverse chronic pain conditions. Results from this study will fill several critical gaps in evidence that are preventing patients and physicians from making informed decisions about their pain care.
This study will provide a low-cost, relatively low-risk, widely available and feasible protocol that directly addresses the needs of millions of community-based outpatients and their physicians.
- Conditions
- Pain, Chronic, Lupus, Pelvic Pain
- Being tested
- Cognitive Behavioral Therapy (CBT), Empowered Relief
- Keywords
- Young adult, Lupus, Pelvic Pain, Behavioral Health
- Medical subject headings
- Chronic Pain, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy (CBT)Behavioural
A trained psychologist delivers 8 sessions of low-literacy CBT (the LAMP protocol) to groups of patients who were randomized to this treatment arm.
Empowered ReliefBehavioural
A certified instructor delivers 1 session of pain relief skills intervention (Empowered Relief) to groups of patients who were randomized to this treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| Lupus Chronic Pain Cohort | Experimental | 150 participants with Lupus and Chronic Pain Receives: Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Empowered Relief |
| Chronic Pelvic Pain | Experimental | 150 participants with Chronic Pelvic Pain Receives: Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Empowered Relief |
| Young Adult (18-23) Chronic Pain | Experimental | 150 participants ages 18-23 with Chronic Pain Receives: Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Empowered Relief |
| PRIME Sample | Experimental | 1200 participants with chronic pain Receives: Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Empowered Relief |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)
Measured: 1 months
Pain Intensity
Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)
Measured: 2 months
Pain Intensity
Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)
Measured: 3 months
Pain Intensity
Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)
Measured: 6 months
Pain Interference
Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)
Measured: 1 month
Pain Interference
Compare study treatments for primary outcomes post-treatment with the PROMIS Pain Interference 6-item scale.
Measured: 2 months
Pain Interference
Compare study treatments for primary outcomes post-treatment with the PROMIS Pain Interference 6-item scale.
Measured: 3 months
Pain Interference
Compare study treatments for primary outcomes post-treatment with the PROMIS Pain Interference 6-item scale.
Measured: 6 months
Secondary outcomes (36)
Sleep Disturbance
Compare treatment groups on the PROMIS Sleep Disturbance 6-item
Measured: 1 month
Sleep Disturbance
Compare treatment groups on the PROMIS Sleep Disturbance 6-item
Measured: 2 months
Sleep Disturbance
Compare treatment groups on the PROMIS Sleep Disturbance 6-item
Measured: 3 months
Sleep Disturbance
Compare treatment groups on the PROMIS Sleep Disturbance 6-item
Measured: 6 months
Pain Bothersomeness
Compare treatment groups for Pain Bothersomeness on a Numeric Rating Scale (0-10)
Measured: 1 month
Pain Bothersomeness
Compare treatment groups for Pain Bothersomeness on a Numeric Rating Scale (0-10)
Measured: 2 months
Pain Bothersomeness
Compare treatment groups for Pain Bothersomeness on a Numeric Rating Scale (0-10)
Measured: 3 months
Pain Bothersomeness
Compare treatment groups for Pain Bothersomeness on a Numeric Rating Scale (0-10)
Measured: 6 months
Pain Catastrophizing
Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing.
Measured: 1 months
Pain Catastrophizing
Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing.
Measured: 2 months
Pain Catastrophizing
Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing. We aim to obtain >30% reduction in PCS scores after the intervention
Measured: 3 months
Pain Catastrophizing
Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing.
Measured: 6 months
Anxiety
Compare treatment groups for anxiety using the PROMIS Anxiety 6-item
Measured: 1 month
Anxiety
Compare treatment groups for anxiety using the PROMIS Anxiety 6-item
Measured: 2 months
Anxiety
Compare treatment groups for anxiety using the PROMIS Anxiety 6-item
Measured: 3 months
Anxiety
Compare treatment groups for anxiety using the PROMIS Anxiety 6-item
Measured: 6 months
Satisfaction with Social Roles/Responsibilities
Compare treatment groups for PROMIS 6 item Satisfaction with Social Roles/Responsibilities
Measured: 1 month
Satisfaction with Social Roles/Responsibilities
Compare treatment groups for PROMIS 6 item Satisfaction with Social Roles/Responsibilities
Measured: 2 months
Satisfaction with Social Roles/Responsibilities
Compare treatment groups for PROMIS 6 item Satisfaction with Social Roles/Responsibilities
Measured: 3 months
Satisfaction with Social Roles/Responsibilities
Compare treatment groups for PROMIS 6 item Satisfaction with Social Roles/Responsibilities
Measured: 6 months
Patient Global Impression of Change
Compare treatment groups for PROMISE 1 item Global Impression of Change scale
Measured: 1months
Patient Global Impression of Change
Compare treatment groups for PROMISE 1 item Global Impression of Change scale
Measured: 2 month
Patient Global Impression of Change
Compare treatment groups for PROMISE 1 item Global Impression of Change scale
Measured: 3 months
Patient Global Impression of Change
Compare treatment groups for PROMISE 1 item Global Impression of Change scale
Measured: 6 months
Depression
Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Depression scale.
Measured: 1 month
Depression
Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Depression scale.
Measured: 2 months
Depression
Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Depression scale.
Measured: 3 months
Depression
Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Depression scale.
Measured: 6 months
Fatigue
Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Fatigue scale.
Measured: 1 month
Fatigue
Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Fatigue scale.
Measured: 2 months
Fatigue
Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Fatigue scale.
Measured: 3 months
Fatigue
Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Fatigue scale.
Measured: 6 months
Anger
Compare study treatments for primary outcomes post-treatment with the PROMIS 5 item Anger scale.
Measured: 1 month
Anger
Compare study treatments for primary outcomes post-treatment with the PROMIS 5 item Anger scale.
Measured: 2 months
Anger
Compare study treatments for primary outcomes post-treatment with the PROMIS 5 item Anger scale.
Measured: 3 months
Anger
Compare study treatments for primary outcomes post-treatment with the PROMIS 5 item Anger scale.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start1 Jan 2023
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pragmatic clinical trial randomizing to one of two (standard of care) online group behavioral treatments: (1) 8-session cognitive behavioral therapy for chronic pain (pain-CBT); and (2) single-session pain relief skills intervention for chronic pain (Empowered Relief).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Beth Darnall, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612750
- Sponsor's protocol ID
- IRB-65439
- Acronym
- PROGRESS
- Status last verified
- Apr 2026
- First submitted
- 5 Aug 2022
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Falasinnu T, Hailu AY, Monson EA, Clifton J, Torres C, Dildine TC, Dorsonne B, Heggan E, Riazi G, Slater K, Poupore-King H, Perez L, Hellewell J, Tian L, Denton S, DeVries A, Miefert J, Mackey SC, Cheung M, Darnall BD. Empowered Relief vs Cognitive Behavioral Therapy for Patients With Systemic Lupus Erythematosus and Chronic Pain: Study Protocol for a National, Randomized, Noninferiority Trial. JMIR Res Protoc. 2026 Aug 25;15:e100104. doi: 10.2196/100104.
PubMed 42641149Adair Monson E, Mardian A, Saxena K, Dorsonne B, Hailu AY, Heggan E, Riazi G, Slater K, Poupore-King H, Clifton J, Perez L, Tian L, Porter J, Denton S, Hanson ER, Miefert J, Thorn BE, Mackey SC, Cheung M, Darnall BD. Randomized comparative effectiveness study of 1-session vs 8-session online behavioral treatment for chronic pain: protocol for the national PROGRESS study. Pain Med. 2026 Jul 1;27(7):839-850. doi: 10.1093/pm/pnag027.
PubMed 41712512
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Online Cognitive Behavioral Therapy vs. An Online Single-Session Pain Relief Skills Class for Chronic Pain - The PROGRESS Study
- ClinicalTrials.gov ID
- NCT05612750
- Acronym / sponsor ID
- PROGRESS / IRB-65439
- Conditions
- Pain, Chronic, Lupus, Pelvic Pain
- Keywords
- Young adult, Lupus, Pelvic Pain, Behavioral Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,650 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 10 Nov 2022 (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 conduct a pragmatic clinical trial comparing the effectiveness of: (1) 8-week cognitive behavioral therapy for chronic pain (pain-CBT; sixteen hours total treatment time); and (2) a 1-session pain relief skills intervention for chronic pain (Empowered Relief; two hours total treatment time).
Detailed description
The purpose of this study is to conduct a pragmatic clinical trial comparing the effectiveness: (1) 8-session cognitive behavioral therapy for chronic pain (pain-CBT); and (2) a 1-session pain relief skills intervention for chronic pain (Empowered Relief). The investigators aim to understand for patients which treatment works best.
Online evidence-based behavioral treatment for pain will greatly expand access to patients across the U.S. living with diverse chronic pain conditions. Results from this study will fill several critical gaps in evidence that are preventing patients and physicians from making informed decisions about their pain care.
This study will provide a low-cost, relatively low-risk, widely available and feasible protocol that directly addresses the needs of millions of community-based outpatients and their physicians.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- A pragmatic clinical trial randomizing to one of two (standard of care) online group behavioral treatments: (1) 8-session cognitive behavioral therapy for chronic pain (pain-CBT); and (2) single-session pain relief skills intervention for chronic pain (Empowered Relief).
| Arm | Type | Receives |
|---|---|---|
| Lupus Chronic Pain Cohort | Experimental | Behavioral: Cognitive Behavioral Therapy (CBT), Behavioral: Empowered Relief150 participants with Lupus and Chronic Pain |
| Chronic Pelvic Pain | Experimental | Behavioral: Cognitive Behavioral Therapy (CBT), Behavioral: Empowered Relief150 participants with Chronic Pelvic Pain |
| Young Adult (18-23) Chronic Pain | Experimental | Behavioral: Cognitive Behavioral Therapy (CBT), Behavioral: Empowered Relief150 participants ages 18-23 with Chronic Pain |
| PRIME Sample | Experimental | Behavioral: Cognitive Behavioral Therapy (CBT), Behavioral: Empowered Relief1200 participants with chronic pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years of age or older of either sex (and all genders).
- Chronic pain (pain that occurs on at least half of the days of 3 months or more).
- Past-month average pain intensity score of at least 3/10.
- Ability to adhere to and complete study protocols.
Key exclusion criteria (5 listed)
- Inability to provide informed consent.
- Cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material and/or full participation in the study including group treatment.
- Active suicidality documented in medical records.
- Study staff may exclude individuals with a known history of disruptive behavior to minimize contamination of the learning environment for an entire treatment cohort.
- Receipt of either study treatment in the past 3 months.
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 |
|---|---|---|
| Cognitive Behavioral Therapy (CBT)A trained psychologist delivers 8 sessions of low-literacy CBT (the LAMP protocol) to groups of patients who were randomized to this treatment arm. | Behavioural | Chronic Pelvic Pain, Lupus Chronic Pain Cohort, PRIME Sample, Young Adult (18-23) Chronic Pain |
| Empowered ReliefA certified instructor delivers 1 session of pain relief skills intervention (Empowered Relief) to groups of patients who were randomized to this treatment arm. | Behavioural | Chronic Pelvic Pain, Lupus Chronic Pain Cohort, PRIME Sample, Young Adult (18-23) Chronic Pain |
Primary outcome
Pain Intensity
Time frame: 1 months
Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)
Pain Intensity
Time frame: 2 months
Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)
Pain Intensity
Time frame: 3 months
Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)
Pain Intensity
Time frame: 6 months
Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)
Pain Interference
Time frame: 1 month
Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)
Pain Interference
Time frame: 2 months
Compare study treatments for primary outcomes post-treatment with the PROMIS Pain Interference 6-item scale.
Pain Interference
Time frame: 3 months
Compare study treatments for primary outcomes post-treatment with the PROMIS Pain Interference 6-item scale.
Pain Interference
Time frame: 6 months
Compare study treatments for primary outcomes post-treatment with the PROMIS Pain Interference 6-item scale.
36 secondary outcomes
Sleep Disturbance
Time frame: 1 month
Sleep Disturbance
Time frame: 2 months
Sleep Disturbance
Time frame: 3 months
Sleep Disturbance
Time frame: 6 months
Pain Bothersomeness
Time frame: 1 month
Pain Bothersomeness
Time frame: 2 months
Pain Bothersomeness
Time frame: 3 months
Pain Bothersomeness
Time frame: 6 months
Pain Catastrophizing
Time frame: 1 months
Pain Catastrophizing
Time frame: 2 months
Pain Catastrophizing
Time frame: 3 months
Pain Catastrophizing
Time frame: 6 months
Anxiety
Time frame: 1 month
Anxiety
Time frame: 2 months
Anxiety
Time frame: 3 months
Anxiety
Time frame: 6 months
Satisfaction with Social Roles/Responsibilities
Time frame: 1 month
Satisfaction with Social Roles/Responsibilities
Time frame: 2 months
Satisfaction with Social Roles/Responsibilities
Time frame: 3 months
Satisfaction with Social Roles/Responsibilities
Time frame: 6 months
Patient Global Impression of Change
Time frame: 1months
Patient Global Impression of Change
Time frame: 2 month
Patient Global Impression of Change
Time frame: 3 months
Patient Global Impression of Change
Time frame: 6 months
Depression
Time frame: 1 month
Depression
Time frame: 2 months
Depression
Time frame: 3 months
Depression
Time frame: 6 months
Fatigue
Time frame: 1 month
Fatigue
Time frame: 2 months
Fatigue
Time frame: 3 months
Fatigue
Time frame: 6 months
Anger
Time frame: 1 month
Anger
Time frame: 2 months
Anger
Time frame: 3 months
Anger
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Derived from this study: PubMed 42641149Falasinnu T, Hailu AY, Monson EA, Clifton J, Torres C, Dildine TC, Dorsonne B, Heggan E, Riazi G, Slater K, Poupore-King H, Perez L, Hellewell J, Tian L, Denton S, DeVries A, Miefert J, Mackey SC, Cheung M, Darnall BD. Empowered Relief vs Cognitive Behavioral Therapy for Patients With Systemic Lupus Erythematosus and Chronic Pain: Study Protocol for a National, Randomized, Noninferiority Trial. JMIR Res Protoc. 2026 Aug 25;15:e100104. doi: 10.2196/100104.
- Derived from this study: PubMed 41712512Adair Monson E, Mardian A, Saxena K, Dorsonne B, Hailu AY, Heggan E, Riazi G, Slater K, Poupore-King H, Clifton J, Perez L, Tian L, Porter J, Denton S, Hanson ER, Miefert J, Thorn BE, Mackey SC, Cheung M, Darnall BD. Randomized comparative effectiveness study of 1-session vs 8-session online behavioral treatment for chronic pain: protocol for the national PROGRESS study. Pain Med. 2026 Jul 1;27(7):839-850. doi: 10.1093/pm/pnag027.
- 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy (CBT) and Empowered Relief in people with Pain, Chronic and Lupus, run by Stanford University at 5 sites 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 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: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma A Adair, BS (6097448937, eadair@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: 1 months). The study lists 8 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 NCT05612750, which also lists 2 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 11 May 2026.