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Lumbosacral RadiculopathyMove-MORENCT07125027

A Multicomponent Intervention for Patients With Lumbosacral Radiculopathy: Move-MORE

A study testing Move-MORE in people with Lumbosacral Radiculopathy and Sciatica, run by National University of Natural Medicine at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The Move-MORE study is designed to evaluate a multicomponent mindfulness and movement program for patients with lumbosacral radiculopathy. The program brings together mindfulness training to help participants develop awareness of their body and manage pain-related stress, gentle movement practice to improve comfort… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Move-MORE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
15 Aug 2025to Nov 2026
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults age 18-75 years at the time of enrollment
  • Ability to stand for 10 minutes
  • Presence of lumbosacral radicular pain within the past week that extends below the knee (i.e., pain radiating from the low back into the leg in a nerve root distribution) with or without accompanying low back pain, of at least 12 weeks' duration, AND
  • Tampa Scale of Kinesiophobia score ≥ 23. If TSK < 23, the participant must endorse at least two of the following experiences in the past month on a structured cognitive interview:
  • Avoids movement due to fear of injury
  • Believes pain indicates harm/damage
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  • Believes that movement is unsafe despite clinician reassurance
  • Reports limiting or modifying activity because of fear (not just pain)
  • At least one positive physical examination finding consistent with lumbosacral radiculopathy, including at least one of the following:
  • Positive straight leg raise test (eliciting radicular pain below the knee at ≤70 degrees of elevation);
  • Positive Valsalva maneuver (eliciting radiculcar pain below the knee);
  • Positive slump test;
  • Neurological deficit in a lumbar nerve root distribution, including at least one of the following:
  • Dermatomal sensory loss,
  • Myotomal weakness, or
  • Reduced or absent deep tendon reflexes (e.g., patellar or Achilles reflex) corresponding to the affected nerve root.
  • Daily access to the internet via cell phone, tablet, or computer
  • Willing to engage with Move-MORE 4-5 times per week on your own
  • Willing to attend a two-hour-long virtual Zoom meeting once per week for eight weeks
  • Willing to attend two in-person study visits and a follow-up visit
  • Willing to complete 18 questionnaires pertaining to your pain symptoms, quality of life, psychosocial experiences, and your experiences in the trial
  • Willing to wear an actigraphy device all day, every day, and while sleeping, for the duration of study participation and willing to keep it charged
  • Willing to respond to a daily online survey for the duration of study participation
  • Able to speak, read, and understand the English language
  • Able to provide written informed consent
  • Moderately motivated to participate as reported on a numeric rating scale (≥ 4/10)

Who cannot join

  • Participants will be excluded if they have clinical signs or symptoms of lumbosacral radiculopathy with progressive neurologic deficits (loss of motor or sensory function) or intolerable pain.
  • o Participants with lumbosacral radiculopathy with progressive neurologic deficits will be referred for immediate medical attention, and are not eligible for participation in this study.
  • Participants will be excluded if they have clinical signs or symptoms suggestive of cauda equina syndrome, including any of the following:
  • New-onset urinary retention or overflow incontinence not attributable to other known causes;
  • Fecal incontinence;
  • New onset of saddle anesthesia (loss of sensation in the buttocks, perineum, and inner thighs);
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  • Severe or progressive bilateral lower extremity weakness; ▪ Participants with suspected cauda equina syndrome will be referred for immediate medical attention, and are not eligible for participation in this study.
  • Presence of moderate to severe foot drop, defined as noticeable weakness in ankle dorsiflexion that interferes with walking or requires the use of an assistive device (e.g., ankle-foot orthosis). Participants with suspected or worsening foot drop will be referred for further evaluation and are not eligible for study participation.
  • Current use of a spinal cord stimulator. Individuals with an implanted spinal cord stimulator may be eligible if the device has been deactivated for at least 4 weeks prior to enrollment and the participant agrees to keep the device deactivated for the duration of study enrollment, unless reactivation is medically necessary. Individuals who reactivate spinal cord stimulation during the intervention period may be withdrawn from the study.
  • Have received a lumbosacral nerve ablation in the prior 3 months
  • Have received epidural steroid injection in the prior 3 months
  • Have received a surgical intervention for low back pain or lumbosacral radiculopathy in the previous 6 months
  • Current regular mindfulness meditation practice, defined as formal seated, lying, or walking meditation practiced at least once per week for the past 4 weeks or longer, and/or a history of substantial formal mindfulness or meditation training (e.g., completion of a structured mindfulness-based program, meditation retreat, or equivalent training). Casual awareness of breathing, brief relaxation exercises, prayer, yoga without meditation, general stress-management strategies, or mindful awareness during routine activities do not meet this exclusion criterion unless they are part of a regular formal mindfulness meditation practice.
  • Active malignancy requiring ongoing systemic treatment (e.g., chemotherapy, immunotherapy, targeted therapy, or radiation therapy), or malignancy that, in the judgment of the Principal Investigator or Clinical Investigator, may interfere with study participation, increase participant risk, or plausibly explain the participant's lumbosacral radicular pain. Participants with a history of cancer that has been treated and is currently stable, in remission, or under routine surveillance are eligible. Localized non-melanoma skin cancers (e.g., basal cell carcinoma or squamous cell carcinoma) do not meet this exclusion criterion unless they are expected to interfere with study participation.
  • Current unmanaged or uncontrolled mental illness known to cause psychosis: schizophrenia, schizotypal disorders, bipolar I disorder with psychosis, major depressive disorder with psychosis
  • Diagnosis of Borderline Personality Disorder or score >6 on the McLean Screening Instrument for Borderline Personality Disorder
  • Initiation of or changes to an exercise regimen within 2 weeks prior to screening and/or enrollment
  • Major medical or surgical event requiring hospitalization (for any reason other than a minor scheduled medical procedure) within 3 months prior to screening; or, scheduled or will be scheduled to occur within the 20 weeks (i.e., five months) after enrollment
  • Currently participating in another interventional research study or participated in another interventional study within 2 weeks prior to screening
  • Any reason the Clinical Investigator or Principal Investigator believes confers increased risk to the potential participant, if they were to enroll in the study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ryan S Wexler, ND, MS contact

503-552-1741

morestudy@nunm.edu

Study Coordinator contact

503-552-1752

morestudy@nunm.edu

United States1 site, 1 recruiting

  • National University of Natural Medicine

    Portland, Oregon, 97201

    Study Coordinator, MA, 503-552-1752, morestudy@nunm.edu

    Recruiting

Other trials in United States

About this study

The Move-MORE study is designed to evaluate a multicomponent mindfulness and movement program for patients with lumbosacral radiculopathy. The program brings together mindfulness training to help participants develop awareness of their body and manage pain-related stress, gentle movement practice to improve comfort with physical activity and support function, and motivational interviewing to strengthen motivation, confidence, and the ability to make healthy changes.

The main objectives are to determine whether it is feasible for participants to use each component of the program when delivered online, to assess how acceptable and engaging each component is, and to evaluate the impact on pain, physical function, and daily activity levels. The study intervention will be conducted entirely remotely. Participants will complete online surveys, brief daily check-ins on their phone, and wear a small activity monitor on the hip to measure movement. They will also undergo quantitative sensory testing to evaluate pain sensitivity. At the end of the program, participants will share feedback about their experiences via qualitative interviews.

The findings will help identify which parts of the program provide the greatest benefit, with the ultimate goal of developing a more targeted and effective digital program for people with this condition.

Read the detailed description

Lumbosacral radiculopathy (LR) is a spinal pathology that manifests as pain, weakness, and numbness in the lower extremity. Commonly referred to as "sciatica", LR has a lifetime prevalence up to 43%, and can often become an intractable condition with long-term outcomes unimproved by conventional biomedical treatments such as surgery. Thus, we seek to develop a non-invasive and non-pharmacologic treatment for LR patients

This study aims to 1) develop a multicomponent intervention that integrates Mindfulness-Oriented Recovery Enhancement and physical activity for patients with LR, 2) assess the feasibility and acceptability of this multicomponent intervention, and 3) evaluate preliminary efficacy of the intervention via self-report measures of pain, disability, kinesiophobia, and other psychosocial factors related to chronic pain. In addition, this study will use quantitative sensory testing (i.e., pressure and heat pain thresholds) as an objective measure of pain.

The multicomponent intervention will be developed (AIM 1) using qualitative data from focus groups of LR patients and semi-structured interviews from a multidisciplinary sample of physicians who treat LR. This data will be analyzed using a thematic approach to assess barriers and facilitators to participation, patients' perspectives on non-pharmacologic interventions, and physicians' views of medically necessary considerations. Qualitative findings will be presented to a team of expert mindfulness instructors to support program design. In a single arm trial designed to assess feasibility, acceptability, and preliminary efficacy of the intervention (AIMS 2 and 3), we will administer the multicomponent program developed in Aim 1. Data will be collected from participants at three time points: baseline, midpoint, post-intervention, 3-month follow-up. In addition, ratings of pain intensity will be captured daily via ecologic momentary assessment.

During the intervention period, participants will be asked to attend virtual classes once a week. Between weekly sessions, participants will also be asked to track their home practice, daily levels of pain, and any adverse events via a daily survey. At the end of the study, participants will be asked to participate in a semi-structured exit interview which will inquire about their experience in the intervention.

This study seeks to shift the current research paradigm by being the first to develop and test a novel non-invasive, non-pharmacologic, multicomponent intervention for LR. As such, the proposed research contributes much needed scientific knowledge toward identifying efficacious treatments for a highly prevalent, costly, and intractable condition.

Being tested
Move-MORE
Keywords
Mindfulness, Physical Activity, Motivational Interviewing, Meditation, Tai Chi/Qi Gong, Movement, Mindfulness-Oriented Recovery Enhancement, Mindfulness-Based Interventions, Radiculopathy, Lumbosacral Radiculopathy, Lumbar Radiculopathy, Chronic low back pain, Low back pain, Back Pain
Medical subject headings
Sciatica, Chronic Pain, Motor Activity, Radiculopathy, Low Back Pain, Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Move-MOREBehavioural

    Move-MORE is a multicomponent intervention which combines mindfulness training, physical activity, and motivational interviewing informed by the principles of self-determination theory. The version of Move-MORE being used in this study is specifically designed for use in patients with lumbosacral radiculopathy.

Study groups in NCT07125027
Study groupRoleWhat they receive
TreatmentExperimentalParticipants will go through the multicomponent Move-MORE program. Move-MORE is an integrated mind-body intervention which combines mindfulness, physical activity, and motivational interviewing informed by the principles of self-determination theory
Receives: Behavioral: Move-MORE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment Proportion

    The proportion of patients contacted who consent to screening

    Measured: End of study

  2. Retention

    Retention will be assessed by tracking the percentage of participants who complete their primary endpoint visit

    Measured: End of study

  3. Client Satisfaction Questionnaire

    Intervention Satisfaction. Min = 8, Max = 32. Higher score = greater satisfaction.

    Measured: Week 4, Week 8, Week 20

  4. Adherence

    The proportion of participants completing at least 5 intervention sessions

    Measured: End of study

  5. Adverse Events

    The frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring during the study.

    Measured: End of study

  6. Intervention Satisfaction

    Satisfaction will be measured using the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is a self-report measure designed to assess satisfaction with health services.

    Measured: Week 4, Week 8

Secondary outcomes (25)

  1. Oswestry Disability Index

    Activities of daily living. Min = 0%, Max = 100%. Higher score = worse outcomes.

    Measured: Week 0, Week 4, Week 8, Week 20

  2. painDETECT Questionnaire

    Neuropathic Pain. Min = -1, Max = 38. Higher score = worse outcomes.

    Measured: Week 0, Week 4, Week 8, Week 20

  3. Visual Analog Scale

    Pain Intensity. Min = 0, Max = 10. Higher score = worse pain

    Measured: Daily

  4. Complex Medical Symptoms Inventory

    A questionnaire to assess pain hypersensitivity and allodynia. The CMSI inquires about participants' pain experiences specifically related to hypersensitivity and allodynia to discern whether an individual may experience central sensitization. Currently, no direct measures of self-reported nociplastic pain exist, thus measures of central sensitization can be used as surrogate measures for this construct. The CSI has previously been shown to have strong test-retest reliability in chronic pain patients.

    Measured: Week 0, Week 4, Week 8, Week 20

  5. Nociplastic Pain Questionnaire

    The NPQ is a screening tool designed to identify characteristics of nociplastic pain, which arises from altered nociception without clear evidence of tissue damage or somatosensory system disease. The NPQ assesses symptoms such as widespread pain, fatigue, sleep disturbance, and cognitive difficulties, helping to differentiate nociplastic pain from nociceptive and neuropathic pain mechanisms.

    Measured: Week 0, Week 4, Week 8, Week 20

  6. Patient Global Impression of Change

    The PGIC is a single-item, patient-reported outcome measure that captures a participant's overall perception of improvement or decline in health status since the start of an intervention. Rated on a 7-point Likert scale ranging from "very much improved" to "very much worse," the PGIC provides a global assessment of treatment effectiveness from the patient's perspective.

    Measured: Week 0, Week 4, Week 8, Week 20

  7. Healthcare Utilization Changes

    This questionnaire will assess whether participants have changed their use or plans for use of pain medication, injection, nerve ablation, or surgery as a result of participation in the study.

    Measured: Week 4, Week 8, Week 20

  8. The Pain, Enjoyment of Life and General Activity (PEG-3)

    The PEG-3 is a brief, 3-item measure derived from the Brief Pain Inventory that assesses pain intensity and its impact on enjoyment of life and general activity. Each item is rated on a 0-10 scale, with higher scores indicating greater pain-related interference. The PEG-3 is a validated tool commonly used in both clinical and research settings to monitor pain outcomes efficiently.

    Measured: Week 0, Week 4, Week 8, Week 20

  9. Tampa Scale of Kinesiophobia (TSK-11)

    A questionnaire to assess fear of movement. The TSK-11 is designed to assess the presence of fear of movement. This measure has previously been validated in populations of patients with chronic non-specific low back pain and shown to have good reliability.

    Measured: Week 0, Week 4, Week 8, Week 20

  10. Pain Catastrophizing Scale (PCS)

    A questionnaire to assess pain catastrophizing and rumination. The PCS is ubiquitously used to assess pain catastrophizing via its subscales: helplessness, rumination, and magnification. It has primarily been used and validated in patients with low back pain.

    Measured: Week 0, Week 4, Week 8, Week 20

  11. PROMIS Self-Efficacy for Managing Symptoms 8a

    The PROMIS Self-Efficacy for Managing Symptoms 8a is an 8-item patient-reported measure assessing an individual's confidence in managing symptoms related to their health conditions. It evaluates domains such as controlling symptoms, performing tasks despite symptoms, and coping with the impact of symptoms on daily life. Higher scores indicate greater self-efficacy in symptom management. This tool helps capture patients' perceived ability to handle their health challenges and is useful for tailoring interventions and tracking progress in clinical research.

    Measured: Week 0, Week 4, Week 8, Week 20

  12. PROMIS Ability to Participate in Social Roles

    A questionnaire to assess social participation. The ability to participate in social roles questionnaire is a PROMIS measure designed to evaluate the impact of a condition on social engagement. It has previously been validated with an additional questionnaire, satisfaction with participation in social activities.

    Measured: Week 0, Week 4, Week 8, Week 20

  13. PROMIS Sleep Disturbance 6a + Sleep Duration Question

    This is a validated patient-reported outcome measure assessing perceived sleep quality and disturbances over the past 7 days. The 6-item Sleep Disturbance short form (6a) evaluates aspects such as difficulty falling asleep, staying asleep, and overall sleep satisfaction, while an additional question captures average sleep duration. Scores provide insight into sleep problems that may affect health and functioning.

    Measured: Week 0, Week 4, Week 8, Week 20

  14. Whole Person Health Index (WPHI)

    The WPHI is a simple self-report survey tool that provides a comprehensive snapshot of a person's health. The WPHI can serve as an anchor or reference point for connecting diverse health data, all while keeping the individual's personal health perspective at its core. The WPHI is based on nine questions developed and validated through a collaboration between the National Center for Complementary and Integrative Health (NCCIH) and the National Center for Health Statistics/Centers for Disease Control and Prevention.

    Measured: Week 0, Week 4, Week 8, Week 20

  15. Patients Endorsement of a Biopsychosocial Model of Chronic Pain Scale (PEB)

    A questionnaire to assess participant agreement with the biopsychosocial model of pain. The PEB is designed to assess patient beliefs about the biopsychosocial model of chronic pain. It has been previously shown to have good internal consistency and reliability and it has been recommended for use in longitudinal study designs for assessing patients' attitudes towards long-term pain management.

    Measured: Week 0, Week 4, Week 8, Week 20

  16. World Health Organization Quality of Life Questionnaire - 2 (WHOQOL-2)

    The WHOQOL-2 is a brief, validated instrument developed by the WHO to assess an individual's perceived quality of life across multiple domains, including physical health, psychological well-being, social relationships, and environment. It provides a global measure of overall life satisfaction and well-being.

    Measured: Week 0, Week 4, Week 8, Week 20

  17. Patient Health Questionnaire - 8 (PHQ-8)

    The PHQ-9 is a widely used self-report instrument for assessing the presence and severity of depressive symptoms over the past two weeks. The PHQ-8 excludes the item on suicidal ideation found in the PHQ-9, making it suitable for general population surveys and clinical research where suicide risk assessment is conducted separately.

    Measured: Week 0, Week 4, Week 8, Week 20

  18. Generalized Anxiety Questionnaire-7 (GAD-7)

    The GAD-7 is a brief, validated self-report questionnaire used to screen for and assess the severity of generalized anxiety disorder symptoms. It consists of seven items asking respondents how often they have been bothered by anxiety-related problems over the past two weeks. Scores help categorize anxiety severity from minimal to severe and assist clinicians and researchers in monitoring anxiety symptoms and treatment response. The GAD-7 is widely used in both clinical and research settings for its reliability and ease of administration.

    Measured: Week 0, Week 4, Week 8, Week 20

  19. Treatment Self-Regulation Questionnaire (TSRQ)

    The TSRQ is a validated self-report measure designed to assess individuals' motivation behind engaging in health-related behaviors. It evaluates the degree to which behavior change is driven by autonomous (intrinsic) versus controlled (extrinsic) motivation, grounded in Self-Determination Theory. The TSRQ helps identify the reasons patients choose to adhere to or modify treatments, providing insights into their internalization of health goals. It is commonly used in research to understand motivational factors influencing treatment adherence and lifestyle changes.

    Measured: Week 0, Week 4, Week 8, Week 20

  20. International Physical Activity Questionnaire (IPAQ)

    The IPAQ is a 12-question validated tool designed to capture information about a range of physical activity frequency, intensity, time, and type. The IPAQ has been shown to have high repeatability, with 75% of the Spearman correlation coefficients observed in a 12-country validation study to be above 0.65 and ranging from 0.88 to 0.32. The IPAQ also demonstrated high criterion validity ranging from 0.14 to 0.53, with a median of about 0.30. Reliability and validity have also been assessed in other languages and populations both healthy and unhealthy.

    Measured: Week 0, Week 4, Week 8, Week 20

  21. Five Facet Mindfulness Questionnaire (FFMQ)

    A questionnaire to assess participants trait mindfulness. The FFMQ is a self-report questionnaire that assesses trait mindfulness using five categories of mindfulness: Observing, Describing, Acting with Awareness, Nonjudging of inner experience, and Nonreactivity to inner experience. The FFMQ has demonstrated good construct, discriminant, and predictive validity, as well as its internal consistency.

    Measured: Week 0, Week 4, Week 8, Week 20

  22. Mindful Reappraisal of Pain Scale (MRPS)

    A questionnaire to assess participants pain reappraisal. The MRPS is a self-report questionnaire designed to quantify mindful reappraisal of pain. This survey is measured on a scale from 0, "never do that," to 6, "always do that". It was found to have good convergent and discriminant validity with various other mindfulness questionnaires and be sensitive to change in participants undergoing mindfulness interventions.

    Measured: Week 0, Week 4, Week 8, Week 20

  23. Multidimensional Assessment of Interceptive Awareness - Version 2 (MAIA-2)

    A questionnaire to assess interoception. The MAIA-2 is designed as a tool to assess interoceptive awareness. It is made up of eight subscales including: noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trust. It has been previously evaluated with internal consistency, validity, and reliability.

    Measured: Week 0, Week 4, Week 8, Week 20

  24. Purpose in Life Scale

    The Purpose in Life Scale is a self-report instrument designed to assess an individual's sense of meaning, purpose, and direction in life. It measures the extent to which a person feels their life has meaning and goals that give motivation and fulfillment. This scale is commonly used in psychological and health research to evaluate well-being, resilience, and overall mental health. Higher scores indicate a stronger sense of life purpose, which is associated with better psychological outcomes and coping abilities.

    Measured: Week 0, Week 4, Week 8, Week 20

  25. PROMIS Physical Functioning Short Form 6b

    The PROMIS Physical Functioning Short Form 6b is a brief, validated patient-reported outcome measure that assesses an individual's ability to perform everyday physical activities. It includes six items focused on mobility, self-care, and upper extremity function, capturing the impact of health conditions on physical functioning. Scores provide a standardized assessment of physical capabilities, with higher scores indicating better physical function. This tool is widely used in clinical and research settings to monitor physical health status and track changes over time.

    Measured: Week 0, Week 4, Week 8, Week 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2025
  2. Study start15 Aug 2025
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07125027
Sponsor's protocol ID
RW6625
Other IDs
K12NS130673
Acronym
Move-MORE
Status last verified
Nov 2025
First submitted
9 Aug 2025
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data that support the findings of this study are available from the corresponding author, R.S.W., upon reasonable request.

Questions about this trial

What is this clinical trial studying?

A study testing Move-MORE in people with Lumbosacral Radiculopathy and Sciatica, run by National University of Natural Medicine 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 26 inclusion and 20 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 26 Aug 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?

Contact Ryan S Wexler, ND, MS (503-552-1741, morestudy@nunm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment Proportion (time frame: End of study). The study lists 6 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 NCT07125027.

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 26 Aug 2026.

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