Chronic PainNCT06994988
ARPA-H Smart Band-Aid to Measure Chronic Pain in Women
An observational study of Chronic Pain, run by Northwestern University at 2 sites in United States.
Trial summary
The goal of this clinical trial is to test whether a minimally invasive microneedle patch, called the A-Band (Smart Band-aid), worn on the arm (monitoring key biomarkers in interstitial fluid) and a commercial smartwatch can accurately correlate with self-reported pain in women with chronic pain. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- A-Band (Smart Band-Aid), Empatica Smartwatch and Questionnaires: Hospital Anxiety & Depression Scale, Central Sensitization Inventory, Pain Catastrophizing Scale, Somatic Symptom Scale-8, Pain Self-Efficacy Questionnaire-10, Athens Insomnia Scale
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 115 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Jul 2026to 23 Apr 2027
- Phase
- Observational
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Biological females with chronic pain and biological females without chronic pain
Who may be able to join
- For chronic pain group:
- Female, 18 years or older.
- Diagnosis of chronic pain condition (e.g., fibromyalgia, chronic lower back pain) as determined by the Principal Investigator.
- Ability to provide informed consent.
- For healthy controls:
- Female, 18 years or older.
Show all 10Show fewer
- No history of chronic pain.
- No significant or poorly controlled medical conditions as determined by the Principal Investigator and exclusion criteria.
- No significant active, poorly controlled psychological conditions as determined by the Principal Investigator and exclusion criteria.
- Ability to provide informed consent.
Who cannot join
- Pregnant or breastfeeding women.
- Substance abuse or psychiatric disorders that interfere with study participation.
- Major medical conditions (such as severe cardiovascular, neurological, cancer or autoimmune diseases) or psychological conditions (e.g., active, poorly-controlled depression, anxiety disorder, PTSD, substance use disorder) that interfere with study participation.
- Possibility of secondary financial gain from participation
- Interventional pain treatment(s) within 6 weeks of baseline (injection, epidural, etc.)
- Current opioid usage or usage within 2 weeks of baseline
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Walter Reed National Military Medical Center
Bethesda, Maryland, 20814
Miana Atkins, MPH, 240-688-1745, miana.atkins.ctr@usuhs.edu
- Recruiting
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Jordan Wood, BS, 312-695-0915, jordan.wood1@northwestern.edu
About this study
Official title: Multi-modal Smart Band-Aid for AI-based Quantification of Pain
The goal of this clinical trial is to test whether a minimally invasive microneedle patch, called the A-Band (Smart Band-aid), worn on the arm (monitoring key biomarkers in interstitial fluid) and a commercial smartwatch can accurately correlate with self-reported pain in women with chronic pain. A secondary purpose of the study is to identify demographic and clinical variables impacting pain measurement.
The main questions that this study aims to answer are:
Read more
- What is the correlation between AI-adjusted pain scores, based on biomarkers and validated tools, and self-reported pain scores?
- What influence do demographic and clinical information have in the correlation of these pain scores?
Researchers will compare data from these tools with self-reported pain scores in women with chronic pain and healthy women.
Participants will:
- Be a part of the study for approximately 8 days
- Attend 2-3 in-person visits at the applicable clinical center over approximately one week
- Wear a Smart Band-Aid (A-Band) at least twice per day for a week, with each application lasting up to 90 minutes
- Complete questionnaires regarding medical history, pain information, mental health, sleep, and demographic data
- Record daily pain scores
- Wear a smartwatch for one week which will collect biophysical data (heart rate, skin response, etc.)
- Collect daily saliva samples
- Have blood drawn by medical staff at 2 in-person visits
Read the detailed description
This study proposes the collection of interstitial fluid (ISF) from participants using a microneedle patch. ISF is a natural fluid found between your cells that can inform us on your bodily readings and health. A microneedle patch is a safe alternative to standard fluid collection which uses tiny needles to collect the ISF. The patches consist of single-use, sterile (clean) microneedles created from biocompatible materials. These microneedles penetrate the outermost skin layer without causing significant discomfort, pain, or bleeding.
The A-Band is an investigational device and has not been approved for use by the Food and Drug Administration (FDA).
- Conditions
- Chronic Pain
- Being tested
- A-Band (Smart Band-Aid), Empatica Smartwatch, Questionnaires: Hospital Anxiety & Depression Scale, Central Sensitization Inventory, Pain Catastrophizing Scale, Somatic Symptom Scale-8, Pain Self-Efficacy Questionnaire-10, Athens Insomnia Scale
- Keywords
- Smart Band-Aid, A-Band, Chronic Pain, ARPA-H, AI and Chronic Pain, Objective measure, Biomarker
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-Band (Smart Band-Aid)Device
The A-Band is a smart band-aid placed on the forearm or other designated site that collects interstitial fluid (ISF) from participants using a microneedle patch. ISF is a natural fluid found between your cells that can inform us on your bodily readings and health. A microneedle patch is a safe alternative to standard fluid collection which uses tiny needles to collect the ISF. The patches consist of single-use, sterile (clean) microneedles created from biocompatible materials. These microneedles penetrate the outermost skin layer without causing significant discomfort, pain, or bleeding.
Empatica SmartwatchCombination product
A commercial smart band will be worn by participants for 22+ hours a day for approximately 7 days. The smart band collects biophysical data from the participant. This includes data on biomarkers, heart rate and heart rate variability, galvanic skin response, step count, and temperature fluctuations, among other biophysical data.
Questionnaires: Hospital Anxiety & Depression Scale, Central Sensitization Inventory, Pain Catastrophizing Scale, Somatic Symptom Scale-8, Pain Self-Efficacy Questionnaire-10, Athens Insomnia ScaleBehavioural
HADS- measures anxiety and depression (0-21, higher scores signify greater pathology); CSI- measures central sensitization (0-100, higher scores signify greater central sensitization, PCS- measures catastrophizing (0-52, higher scores signify greater catastrophization), SSS-8- measures somatization (0-32, higher scores signify greater somatization), PSEQ-10- measures self-efficacy (0-60, with lower scores signifying low self-efficacy), AIS- measures sleep (0-28, with higher scores signifying greater sleep dysfunction)
| Study group | Role | What they receive |
|---|---|---|
| Chronic pain patients | 85 female patients with chronic pain > 3 months duration Receives: Device: A-Band (Smart Band-Aid); Combination Product: Empatica Smartwatch; Behavioral: Questionnaires: Hospital Anxiety & Depression Scale, Central Sensitization Inventory, Pain Catastrophizing Scale, Somatic Symptom Scale-8, Pain Self-Efficacy Questionnaire-10, Athens Insomnia Scale | |
| Healthy control patients | 35 healthy control patients Receives: Device: A-Band (Smart Band-Aid); Combination Product: Empatica Smartwatch; Behavioral: Questionnaires: Hospital Anxiety & Depression Scale, Central Sensitization Inventory, Pain Catastrophizing Scale, Somatic Symptom Scale-8, Pain Self-Efficacy Questionnaire-10, Athens Insomnia Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between patient-reported pain score and objective pain score as calculated by AI
We will measure the difference between the patient-reported pain scores and AI-generated objective pain score in subgroups of chronic pain patients (e.g., nociplastic pain, neuropathic pain, nociceptive pain, mixed pain) and healthy controls (if they have acute pain).
Measured: Days 0 thru 7, for 8 total days
Secondary outcomes (2)
Pain Scores from Biochemical and Biophysical Measurements & Instruments Measured from Questionnaires (affective-motivational and cognitive components)
Biomarker readings from interstitial fluid, blood serum, and a commercial smart band will be inserted into an AI machine learning algorithm and combined with the scores on the instruments measuring the affective and cognitive pain components to develop an "objective" pain score. The affective-motivational component will be determined by scores on the Hospital Anxiety \& Depression Scale, Somatic Symptom Scale-8 \& Athens Insomnia Scale. The cognitive-evaluative component will be determined by scores on the Pain Catastrophizing Scale, Pain Self-Efficacy Questionnaire-10 and Somatic Symptom Scale-8.
Measured: From Day 0 thru Day 7, for 8 total days
Patient-reported pain score
Patient-reported pain scale on a 0-10 pain scale (Defense and Veterans Pain Rating Scale), recorded at least twice per day upon patch application.
Measured: Days 0 thru 7, for 8 total days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start6 Jul 2026
- Primary completion23 Apr 2027 (estimated)
- Study completion23 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Tufts University, Advanced Research Projects Agency for Health (ARPA-H), Walter Reed National Military Medical Center, Uniformed Services University of the Health Sciences, Henry M. Jackson Foundation for the Advancement of Military Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994988
- Sponsor's protocol ID
- STU00223452
- Other IDs
- FP00008853
- Status last verified
- Sep 2026
- First submitted
- 20 May 2025
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: IPD will be shared upon request with IRB approval.
Publications
Guo LL, Pfohl SR, Fries J, Johnson AEW, Posada J, Aftandilian C, Shah N, Sung L. Evaluation of domain generalization and adaptation on improving model robustness to temporal dataset shift in clinical medicine. Sci Rep. 2022 Feb 17;12(1):2726. doi: 10.1038/s41598-022-06484-1.
PubMed 35177653Wu Z, Yao H, Liebovitz D, Sun J. An iterative self-learning framework for medical domain generalization. Advances in Neural Information Processing Systems. 2024 Feb 13;36.
Strawbridge R, Young AH, Cleare AJ. Biomarkers for depression: recent insights, current challenges and future prospects. Neuropsychiatr Dis Treat. 2017 May 10;13:1245-1262. doi: 10.2147/NDT.S114542. eCollection 2017.
PubMed 28546750Yang J, Luo R, Yang L, Wang X, Huang Y. Microneedle-Integrated Sensors for Extraction of Skin Interstitial Fluid and Metabolic Analysis. Int J Mol Sci. 2023 Jun 8;24(12):9882. doi: 10.3390/ijms24129882.
PubMed 37373027Diaz MM, Caylor J, Strigo I, Lerman I, Henry B, Lopez E, Wallace MS, Ellis RJ, Simmons AN, Keltner JR. Toward Composite Pain Biomarkers of Neuropathic Pain-Focus on Peripheral Neuropathic Pain. Front Pain Res (Lausanne). 2022 May 11;3:869215. doi: 10.3389/fpain.2022.869215. eCollection 2022.
PubMed 35634449Telli H, Ozdemir C. Is nociplastic pain, a new pain category, associated with biochemical, hematological, and inflammatory parameters? Curr Med Res Opin. 2024 Mar;40(3):469-481. doi: 10.1080/03007995.2024.2304106. Epub 2024 Jan 22.
PubMed 38204412Eldabe S, Obara I, Panwar C, Caraway D. Biomarkers for Chronic Pain: Significance and Summary of Recent Advances. Pain Res Manag. 2022 Nov 7;2022:1940906. doi: 10.1155/2022/1940906. eCollection 2022.
PubMed 36385904Tracey I, Woolf CJ, Andrews NA. Composite Pain Biomarker Signatures for Objective Assessment and Effective Treatment. Neuron. 2019 Mar 6;101(5):783-800. doi: 10.1016/j.neuron.2019.02.019.
PubMed 30844399
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-modal Smart Band-Aid for AI-based Quantification of Pain
- ClinicalTrials.gov ID
- NCT06994988
- Acronym / sponsor ID
- STU00223452
- Conditions
- Chronic Pain
- Keywords
- Smart Band-Aid, A-Band, Chronic Pain, ARPA-H, AI and Chronic Pain, Objective measure, Biomarker
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Tufts University, Advanced Research Projects Agency for Health (ARPA-H), Walter Reed National Military Medical Center, Uniformed Services University of the Health Sciences, Henry M. Jackson Foundation for the Advancement of Military Medicine
- Study start
- 6 Jul 2026 (actual)
- Primary completion
- 23 Apr 2027 (estimated)
- Study completion
- 23 Apr 2027 (estimated)
- First posted
- 29 May 2025 (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 test whether a minimally invasive microneedle patch, called the A-Band (Smart Band-aid), worn on the arm (monitoring key biomarkers in interstitial fluid) and a commercial smartwatch can accurately correlate with self-reported pain in women with chronic pain. A secondary purpose of the study is to identify demographic and clinical variables impacting pain measurement.
The main questions that this study aims to answer are:
- What is the correlation between AI-adjusted pain scores, based on biomarkers and validated tools, and self-reported pain scores?
- What influence do demographic and clinical information have in the correlation of these pain scores?
Researchers will compare data from these tools with self-reported pain scores in women with chronic pain and healthy women.
Participants will:
- Be a part of the study for approximately 8 days
- Attend 2-3 in-person visits at the applicable clinical center over approximately one week
- Wear a Smart Band-Aid (A-Band) at least twice per day for a week, with each application lasting up to 90 minutes
- Complete questionnaires regarding medical history, pain information, mental health, sleep, and demographic data
- Record daily pain scores
- Wear a smartwatch for one week which will collect biophysical data (heart rate, skin response, etc.)
- Collect daily saliva samples
- Have blood drawn by medical staff at 2 in-person visits
Detailed description
This study proposes the collection of interstitial fluid (ISF) from participants using a microneedle patch. ISF is a natural fluid found between your cells that can inform us on your bodily readings and health. A microneedle patch is a safe alternative to standard fluid collection which uses tiny needles to collect the ISF. The patches consist of single-use, sterile (clean) microneedles created from biocompatible materials. These microneedles penetrate the outermost skin layer without causing significant discomfort, pain, or bleeding.
The A-Band is an investigational device and has not been approved for use by the Food and Drug Administration (FDA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic pain patients | – | Device: A-Band (Smart Band-Aid), Combination Product: Empatica Smartwatch, Behavioral: Questionnaires: Hospital Anxiety & Depression Scale, Central Sensitization Inventory, Pain Catastrophizing Scale, Somatic Symptom Scale-8, Pain Self-Efficacy Questionnaire-10, Athens Insomnia Scale85 female patients with chronic pain > 3 months duration |
| Healthy control patients | – | Device: A-Band (Smart Band-Aid), Combination Product: Empatica Smartwatch, Behavioral: Questionnaires: Hospital Anxiety & Depression Scale, Central Sensitization Inventory, Pain Catastrophizing Scale, Somatic Symptom Scale-8, Pain Self-Efficacy Questionnaire-10, Athens Insomnia Scale35 healthy control patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Biological females with chronic pain and biological females without chronic pain
Key inclusion criteria (10 listed)
- Female, 18 years or older.
- Diagnosis of chronic pain condition (e.g., fibromyalgia, chronic lower back pain) as determined by the Principal Investigator.
- Ability to provide informed consent.
- Female, 18 years or older.
- No history of chronic pain.
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| A-Band (Smart Band-Aid)The A-Band is a smart band-aid placed on the forearm or other designated site that collects interstitial fluid (ISF) from participants using a microneedle patch. ISF is a natural fluid found between your cells that can inform us on your bodily readings and health. A microneedle patch is a safe alternative to standard fluid collection which uses tiny needles to collect the ISF. The patches consist of single-use, sterile (clean) microneedles created from biocompatible materials. These microneedles penetrate the outermost skin layer without causing significant discomfort, pain, or bleeding. | Device | Chronic pain patients, Healthy control patients |
| Empatica SmartwatchA commercial smart band will be worn by participants for 22+ hours a day for approximately 7 days. The smart band collects biophysical data from the participant. This includes data on biomarkers, heart rate and heart rate variability, galvanic skin response, step count, and temperature fluctuations, among other biophysical data. | Combination product | Chronic pain patients, Healthy control patients |
| Questionnaires: Hospital Anxiety & Depression Scale, Central Sensitization Inventory, Pain Catastrophizing Scale, Somatic Symptom Scale-8, Pain Self-Efficacy Questionnaire-10, Athens Insomnia ScaleHADS- measures anxiety and depression (0-21, higher scores signify greater pathology); CSI- measures central sensitization (0-100, higher scores signify greater central sensitization, PCS- measures catastrophizing (0-52, higher scores signify greater catastrophization), SSS-8- measures somatization (0-32, higher scores signify greater somatization), PSEQ-10- measures self-efficacy (0-60, with lower scores signifying low self-efficacy), AIS- measures sleep (0-28, with higher scores signifying greater sleep dysfunction) | Behavioural | Chronic pain patients, Healthy control patients |
Primary outcome
Difference between patient-reported pain score and objective pain score as calculated by AI
Time frame: Days 0 thru 7, for 8 total days
We will measure the difference between the patient-reported pain scores and AI-generated objective pain score in subgroups of chronic pain patients (e.g., nociplastic pain, neuropathic pain, nociceptive pain, mixed pain) and healthy controls (if they have acute pain).
2 secondary outcomes
Pain Scores from Biochemical and Biophysical Measurements & Instruments Measured from Questionnaires (affective-motivational and cognitive components)
Time frame: From Day 0 thru Day 7, for 8 total days
Patient-reported pain score
Time frame: Days 0 thru 7, for 8 total days
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 14 Sep 2026.
- Background: PubMed 35177653Guo LL, Pfohl SR, Fries J, Johnson AEW, Posada J, Aftandilian C, Shah N, Sung L. Evaluation of domain generalization and adaptation on improving model robustness to temporal dataset shift in clinical medicine. Sci Rep. 2022 Feb 17;12(1):2726. doi: 10.1038/s41598-022-06484-1.
- BackgroundWu Z, Yao H, Liebovitz D, Sun J. An iterative self-learning framework for medical domain generalization. Advances in Neural Information Processing Systems. 2024 Feb 13;36.
- Background: PubMed 28546750Strawbridge R, Young AH, Cleare AJ. Biomarkers for depression: recent insights, current challenges and future prospects. Neuropsychiatr Dis Treat. 2017 May 10;13:1245-1262. doi: 10.2147/NDT.S114542. eCollection 2017.
- Background: PubMed 37373027Yang J, Luo R, Yang L, Wang X, Huang Y. Microneedle-Integrated Sensors for Extraction of Skin Interstitial Fluid and Metabolic Analysis. Int J Mol Sci. 2023 Jun 8;24(12):9882. doi: 10.3390/ijms24129882.
- Background: PubMed 35634449Diaz MM, Caylor J, Strigo I, Lerman I, Henry B, Lopez E, Wallace MS, Ellis RJ, Simmons AN, Keltner JR. Toward Composite Pain Biomarkers of Neuropathic Pain-Focus on Peripheral Neuropathic Pain. Front Pain Res (Lausanne). 2022 May 11;3:869215. doi: 10.3389/fpain.2022.869215. eCollection 2022.
- Background: PubMed 38204412Telli H, Ozdemir C. Is nociplastic pain, a new pain category, associated with biochemical, hematological, and inflammatory parameters? Curr Med Res Opin. 2024 Mar;40(3):469-481. doi: 10.1080/03007995.2024.2304106. Epub 2024 Jan 22.
- Background: PubMed 36385904Eldabe S, Obara I, Panwar C, Caraway D. Biomarkers for Chronic Pain: Significance and Summary of Recent Advances. Pain Res Manag. 2022 Nov 7;2022:1940906. doi: 10.1155/2022/1940906. eCollection 2022.
- Background: PubMed 30844399Tracey I, Woolf CJ, Andrews NA. Composite Pain Biomarker Signatures for Objective Assessment and Effective Treatment. Neuron. 2019 Mar 6;101(5):783-800. doi: 10.1016/j.neuron.2019.02.019.
- Individual participant dataSharing planned: Yes. IPD will be shared upon request with IRB approval.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Northwestern University at 2 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 10 inclusion and 6 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 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Jordan Wood, BS (312-695-0915, jordan.wood1@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between patient-reported pain score and objective pain score as calculated by AI (time frame: Days 0 thru 7, for 8 total days). 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 NCT06994988, which also lists 8 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 14 Sep 2026.