Chronic PainP4PNCT06696352
Partners4Pain & Wellbeing: A Randomized Trial of Community Supported Complementary and Integrative Health Self-management for Back Pain
A study testing Partners4Pain and Keys to Wellbeing in people with Chronic Pain and Back Pain, run by University of Minnesota at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn how well two community-based self-management programs work in people with chronic back or neck pain. The main question it aims to answer is: How well does a community-based self-management program teaching mind-body skills such as mindfulness and cognitive behavioral… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Back Pain, Neck Pain
- What is being tested?
- Partners4Pain and Keys to Wellbeing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2025to Aug 2027
- 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
- 18 years of age or older
- Self-reported chronic back pain (defined as pain in the low or mid back, or neck pain) which has lasted for 3 months or longer
- Score of 3 or higher on the self-reported Pain, Enjoyment of Life and General Activity scale (PEG scale - 0-10)
- Member of one or more of the following populations: American Indian/Alaska Native; Asian; Black/African American; Hispanic/Latino; Native Hawaiian/Pacific Islanders; Socioeconomically disadvantaged (annual household income less than $50,000)
- Reside within the Minneapolis/St. Paul metro region
Who cannot join
- Severe unmanaged mental illness
- Self-reported cancer with active treatment involving radiation or chemotherapy.
- Dementia - Mini Mental State Exam score of 23 or lower for those with suspicion of cognitive impairment
- Self-reported pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Partners for Pain & Wellbeing: A Randomized Trial of Community Supported Complementary and Integrative Health Self Management for Back Pain
The goal of this clinical trial is to learn how well two community-based self-management programs work in people with chronic back or neck pain. The main question it aims to answer is:
How well does a community-based self-management program teaching mind-body skills such as mindfulness and cognitive behavioral approaches (Partners4Pain) work for reducing pain intensity and interference with general activities and enjoyment of life compared to a community-based self-management program focused on general health and wellbeing (Keys to Wellbeing)?
Read more
Participants will be asked to do the following:
- Attend 2 screening visits to learn about the study and see if they meet the requirements to participate.
- Be randomly assigned to one of the two community-based self-management programs.
- Attend 9 weekly self-management program sessions (90 minutes each)
- Complete surveys about their pain and overall health at 2 months (after the programs end), 4 months, and 6 months.
Funding for the project is provided through the National Center for Complementary and Integrative Health (NCCIH) and the National Institute of Neurological Disorders and Stroke (NINDS) through the NIH HEAL Initiative (https://heal.nih.gov/), R33AT012309.
Read the detailed description
This project is a full-scale, multi-level randomized hybrid effectiveness implementation trial (n=376) of 'Partners4Pain', a community supported self-management program for individuals with back or neck pain. Partners4Pain will be compared to an active control, Keys to Wellbeing. Both programs were optimized and feasibility tested in an earlier R61 pilot study of 51 individuals (NCT05786508).
Aims for the hybrid effectiveness implementation trial are:
AIM 1. To assess the relative effectiveness of Partners4Pain versus Keys to Wellbeing in terms of:
- Primary effectiveness outcomes of pain intensity and interference over 6 months using bi-monthly assessments.
- Secondary effectiveness outcomes of pain impact, self-efficacy and other HEAL outcomes.
AIM 2. To assess the impact of health factors on the effectiveness of Partners4Pain for primary and secondary outcomes through subgroup analyses which account for potential complexities between factors.
AIM 3. To describe important implementation related measures that can impact and inform sustained translation of the program with community partner organizations.
- Conditions
- Chronic Pain, Back Pain, Neck Pain, Self-management, Complementary Therapies
- Being tested
- Partners4Pain, Keys to Wellbeing
- Keywords
- Self-Management, Chronic Pain, Neck Pain, Low Back Pain, Complementary Therapies, Back Pain
- Medical subject headings
- Chronic Pain, Back Pain, Neck Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partners4PainBehavioural
This is a group program that will teach participants about different things they can do to manage their pain. They will watch educational videos and do workbook activities. They will learn and practice different exercises and mind-body strategies for pain including back and neck exercises (like strengthening and stretching), mind-body exercises (like meditation, relaxed breathing, guided imagery, and muscle relaxation), problem solving, and how to communicate with others about your pain. They will also have an opportunity to take part in discussions with other group members. The program will be delivered via weekly 90 minute sessions over 9 weeks and will be offered in-person or via videoconference.
Keys to WellbeingBehavioural
This is a group program that will teach participants about different things they can do to improve their health and wellbeing. Participants will watch educational videos and do workbook activities. They will learn different back and neck exercises (like strengthening and stretching) and be introduced to different health-related topics including information and tips about health, pain and wellbeing; keeping active and well; the importance of rest and relaxation; and working with meaning and purpose in your life. They will also have an opportunity to take part in discussions with other group members. The program will be delivered in weekly 90 minute sessions over 9 weeks and will be offered in-person or via videoconference.
| Study group | Role | What they receive |
|---|---|---|
| Partners4Pain | Experimental | Community-based program that focuses on evidence based mind-body tools (mindfulness, cognitive behavioral approaches) for pain self-management in addition to pain education and physical exercises. Receives: Behavioral: Partners4Pain |
| Keys to Wellbeing | Active comparator | Community-based program that focuses on general health and well-being education for pain self-management in addition to pain education and physical exercises. Receives: Behavioral: Keys to Wellbeing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain, Interference with Enjoyment of Life and General Activity
Measured using the Pain, Enjoyment of Life and General Activity (PEG) scale that measures average pain intensity, interference with enjoyment of life, and interference with general activity in the past week. Each item is measured on a 0 (no pain/does not interfere) to 10 numeric rating scale (pain as bad as you can imagine/completely interferes).
Measured: Baseline, 2, 4, 6 months
Secondary outcomes (20)
Graded Chronic Pain Scale
Measured using the Graded Chronic Pain Scale-Revised (GCPS-R), a six item scale developed to differentiate mild, bothersome, and high-impact chronic pain. Two questions to identify chronic pain and high impact chronic pain; frequency of pain during the prior 3 months and frequency of limitation in activities in the prior 3 months.
Measured: Baseline, 2, 6 months
Self-efficacy for Managing Chronic Conditions
Measured using the PROMIS 4-item short forms for 1) managing daily activities; 2) managing symptoms; 3) managing emotions; and 4) managing social interactions. All Items are scored on a 5-point Likert scale (1=I am not confident at all to 5=I am very confident).
Measured: Baseline, 2, 4, 6 months
Domain Specific Life Satisfaction
Domain-Specific Life Satisfaction is a 13-item PROMIS measure of satisfaction with various aspects of life (e.g. education, housing, family life, health, neighborhood). Agreement with statements of satisfaction for each domain are measured on a 5-point scale ranging from Not at all to Very much.
Measured: Baseline, 2, 4, 6 months
Quality of Life and Health Satisfaction
Measured using the World Health Organizations 2-item measure which measures quality of life and satisfaction with health on a 1 to 5 scale.
Measured: Baseline, 2, 4, 6 months
Physical Functioning
The PROMIS Physical functioning 6-item short form v2.0 which measures difficulty doing household activities and agreement with statements on health limitations in physical activities on a 1 to 5 scale.
Measured: Baseline, 2, 4, 6 months
Pain Catastrophizing
Assessed using the Pain Catastrophizing Scale (PCS), a 6-item self-reported measure to indicate the degree to which a person may ruminate, magnify, and feel helpless about their pain. The PCS-6 measures a person's thoughts and feelings when they are experiencing pain using the 0 (not at all) to 4 (all the time) scale.
Measured: Baseline, 2, 4, 6 months
Interoceptive Awareness
Measured using the Multidimensional Assessment of Interoceptive Awareness (MAIA) survey instrument (V2) using the 1) noticing; 2) attention regulation; 3) emotional awareness; and 4) self-regulation subscales.
Measured: Baseline, 2, 4, 6 months
Overall Improvement
Overall improvement will be assessed with the Patient Global Impression of Change (PGIC) which has participants rate their overall change from very much worse to very much improved on a 7-point scale.
Measured: Months 2, 4, 6
Intervention Satisfaction
Assessed using a question that has participants rate their overall satisfaction ranging from completely satisfied to completely dissatisfied on a 7-point scale.
Measured: Months 2, 4, 6
Social Isolation
Measured using the PROMIS 4-item short form v2.0 which measures frequency of different feelings of social isolation on a 1 (Never) to 5 (Always) scale.
Measured: Baseline, 2, 4, 6 months
Healthcare Use
Participant self report of provider visits, emergency department visits, diagnostic imaging scans, hospitalizations, injections and surgical procedures for neck and back pain.
Measured: Baseline, 2, 4, 6 months
Medication Use
Participant self-report of over the counter and prescription medication use for back or neck pain.
Measured: Baseline, 2, 4, 6 months
Complementary Integrative Health Self-Management Use
Includes self-reported complementary and integrative therapy use such as but not limited to massage, acupuncture, acupressure, chiropractic, mind-body therapies (e.g. Reiki), guided imagery, and others.
Measured: Baseline, 2, 4, 6 months
Adverse Events
Participant self-report of any new or worsening health issue while participating in the study. Participants will also be asked to report potential side effects by choosing from a list of known potential risks of exercise and mindfulness interventions.
Measured: 2, 4, 6, months
Sleep Disturbance
Sleep disturbance will be measured using the PROMIS 6-item short form v1.0 which measures sleep quality on a 1 to 5 scale from very poor to very good in addition to agreement with statements on sleep quality on a 1 to 5 scale.
Measured: Baseline, 2, 6 months
Sleep Duration
Participant's will self-report their average amount of sleep per night in the past month in hours and minutes.
Measured: Baseline, 2, 6 months
Anxiety
Anxiety will be measured using the Generalized Anxiety Disorder-2 survey (GAD-2) which includes 2 questions that are summed for a total score that can range from 0 to 6.
Measured: Baseline, 2, 6 months
Depression
Depression will be measured using the Patient Health Questionnaire-2 (PHQ-2) which includes 2 questions that are summed for a total score that can range from 0 to 6.
Measured: Baseline, 2, 6 months
Participation in Social Roles and Activities
Measured using the PROMIS 4-item short form v2.0 which measures frequency of trouble doing activities for leisure, work, or with family or friends on a 1 to 5 scale.
Measured: Baseline, 2, 6 months
Substance Use
Measured using the Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) survey. The TAPS is comprised of a 4-item screen for substance use.
Measured: Baseline, 2, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start6 Jan 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Investigator
- Enrolment
- 376 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Roni L Evans, DC, MS, PhD, Principal investigator, University of MinnesotaBrent Leininger, DC, MS, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696352
- Sponsor's protocol ID
- R33AT012309
- Other IDs
- R33AT012309, STUDY00017917
- Acronym
- P4P
- Status last verified
- May 2026
- First submitted
- 5 Nov 2024
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study data will be submitted to a generalist repository that is participating in the NIH Generalist Repository Ecosystem Initiative. Demographic and clinical outcome measures will be collected and shared using common data elements (CDEs ) from the NIH / HEAL CDE repository. Variable naming and permissible response values will be harmonized according to CDEs data dictionary specifications. Documentation to be made publicly available to the research community and will include: 1. The study protocol; 2. informed consent form; 3. data collection forms/case report forms; 4. data dictionary.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partners for Pain & Wellbeing: A Randomized Trial of Community Supported Complementary and Integrative Health Self Management for Back Pain
- ClinicalTrials.gov ID
- NCT06696352
- Acronym / sponsor ID
- P4P / R33AT012309
- Conditions
- Chronic Pain, Back Pain, Neck Pain, Self-management, Complementary Therapies
- Keywords
- Self-Management, Chronic Pain, Neck Pain, Low Back Pain, Complementary Therapies, Back Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 376 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 20 Nov 2024 (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 goal of this clinical trial is to learn how well two community-based self-management programs work in people with chronic back or neck pain. The main question it aims to answer is:
How well does a community-based self-management program teaching mind-body skills such as mindfulness and cognitive behavioral approaches (Partners4Pain) work for reducing pain intensity and interference with general activities and enjoyment of life compared to a community-based self-management program focused on general health and wellbeing (Keys to Wellbeing)?
Participants will be asked to do the following:
- Attend 2 screening visits to learn about the study and see if they meet the requirements to participate.
- Be randomly assigned to one of the two community-based self-management programs.
- Attend 9 weekly self-management program sessions (90 minutes each)
- Complete surveys about their pain and overall health at 2 months (after the programs end), 4 months, and 6 months.
Funding for the project is provided through the National Center for Complementary and Integrative Health (NCCIH) and the National Institute of Neurological Disorders and Stroke (NINDS) through the NIH HEAL Initiative (https://heal.nih.gov/), R33AT012309.
Detailed description
This project is a full-scale, multi-level randomized hybrid effectiveness implementation trial (n=376) of 'Partners4Pain', a community supported self-management program for individuals with back or neck pain. Partners4Pain will be compared to an active control, Keys to Wellbeing. Both programs were optimized and feasibility tested in an earlier R61 pilot study of 51 individuals (NCT05786508).
Aims for the hybrid effectiveness implementation trial are:
AIM 1. To assess the relative effectiveness of Partners4Pain versus Keys to Wellbeing in terms of:
- Primary effectiveness outcomes of pain intensity and interference over 6 months using bi-monthly assessments.
- Secondary effectiveness outcomes of pain impact, self-efficacy and other HEAL outcomes.
AIM 2. To assess the impact of health factors on the effectiveness of Partners4Pain for primary and secondary outcomes through subgroup analyses which account for potential complexities between factors.
AIM 3. To describe important implementation related measures that can impact and inform sustained translation of the program with community partner organizations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partners4Pain | Experimental | Behavioral: Partners4PainCommunity-based program that focuses on evidence based mind-body tools (mindfulness, cognitive behavioral approaches) for pain self-management in addition to pain education and physical exercises. |
| Keys to Wellbeing | Active comparator | Behavioral: Keys to WellbeingCommunity-based program that focuses on general health and well-being education for pain self-management in addition to pain education and physical exercises. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- Self-reported chronic back pain (defined as pain in the low or mid back, or neck pain) which has lasted for 3 months or longer
- Score of 3 or higher on the self-reported Pain, Enjoyment of Life and General Activity scale (PEG scale - 0-10)
- Member of one or more of the following populations: American Indian/Alaska Native; Asian; Black/African American; Hispanic/Latino; Native Hawaiian/Pacific Islanders; Socioeconomically disadvantaged (annual household income less than $50,000)
- Reside within the Minneapolis/St. Paul metro region
Key exclusion criteria (4 listed)
- Severe unmanaged mental illness
- Self-reported cancer with active treatment involving radiation or chemotherapy.
- Dementia - Mini Mental State Exam score of 23 or lower for those with suspicion of cognitive impairment
- Self-reported pregnancy
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 |
|---|---|---|
| Partners4PainThis is a group program that will teach participants about different things they can do to manage their pain. They will watch educational videos and do workbook activities. They will learn and practice different exercises and mind-body strategies for pain including back and neck exercises (like strengthening and stretching), mind-body exercises (like meditation, relaxed breathing, guided imagery, and muscle relaxation), problem solving, and how to communicate with others about your pain. They will also have an opportunity to take part in discussions with other group members. The program will be delivered via weekly 90 minute sessions over 9 weeks and will be offered in-person or via videoconference. | Behavioural | Partners4Pain |
| Keys to WellbeingThis is a group program that will teach participants about different things they can do to improve their health and wellbeing. Participants will watch educational videos and do workbook activities. They will learn different back and neck exercises (like strengthening and stretching) and be introduced to different health-related topics including information and tips about health, pain and wellbeing; keeping active and well; the importance of rest and relaxation; and working with meaning and purpose in your life. They will also have an opportunity to take part in discussions with other group members. The program will be delivered in weekly 90 minute sessions over 9 weeks and will be offered in-person or via videoconference. | Behavioural | Keys to Wellbeing |
Primary outcome
Pain, Interference with Enjoyment of Life and General Activity
Time frame: Baseline, 2, 4, 6 months
Measured using the Pain, Enjoyment of Life and General Activity (PEG) scale that measures average pain intensity, interference with enjoyment of life, and interference with general activity in the past week. Each item is measured on a 0 (no pain/does not interfere) to 10 numeric rating scale (pain as bad as you can imagine/completely interferes).
20 secondary outcomes
Graded Chronic Pain Scale
Time frame: Baseline, 2, 6 months
Self-efficacy for Managing Chronic Conditions
Time frame: Baseline, 2, 4, 6 months
Domain Specific Life Satisfaction
Time frame: Baseline, 2, 4, 6 months
Quality of Life and Health Satisfaction
Time frame: Baseline, 2, 4, 6 months
Physical Functioning
Time frame: Baseline, 2, 4, 6 months
Pain Catastrophizing
Time frame: Baseline, 2, 4, 6 months
Interoceptive Awareness
Time frame: Baseline, 2, 4, 6 months
Overall Improvement
Time frame: Months 2, 4, 6
Intervention Satisfaction
Time frame: Months 2, 4, 6
Social Isolation
Time frame: Baseline, 2, 4, 6 months
Healthcare Use
Time frame: Baseline, 2, 4, 6 months
Medication Use
Time frame: Baseline, 2, 4, 6 months
Complementary Integrative Health Self-Management Use
Time frame: Baseline, 2, 4, 6 months
Adverse Events
Time frame: 2, 4, 6, months
Sleep Disturbance
Time frame: Baseline, 2, 6 months
Sleep Duration
Time frame: Baseline, 2, 6 months
Anxiety
Time frame: Baseline, 2, 6 months
Depression
Time frame: Baseline, 2, 6 months
Participation in Social Roles and Activities
Time frame: Baseline, 2, 6 months
Substance Use
Time frame: Baseline, 2, 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 12 May 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The study data will be submitted to a generalist repository that is participating in the NIH Generalist Repository Ecosystem Initiative. Demographic and clinical outcome measures will be collected and shared using common data elements (CDEs ) from the NIH / HEAL CDE repository. Variable naming and permissible response values will be harmonized according to CDEs data dictionary specifications. Documentation to be made publicly available to the research community and will include: 1. The study protocol; 2. informed consent form; 3. data collection forms/case report forms; 4. data dictionary.
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
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.
Roni L Evans, DC, MS, PhD principal investigator
University of Minnesota
Brent Leininger, DC, MS, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partners4Pain and Keys to Wellbeing in people with Chronic Pain and Back Pain, run by University of Minnesota 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 4 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 12 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 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?
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?
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?
Pain, Interference with Enjoyment of Life and General Activity (time frame: Baseline, 2, 4, 6 months). 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 12 May 2026.