Spinal DiseaseNCT07543692
Safety and Effectiveness of Ultrasound-guided Pharmacopuncture for Spinal Diseases
An observational study of Spinal Disease and Neck Pain, run by Jaseng Medical Foundation at 6 sites in South Korea.
Trial summary
This multi-center registry study aims to evaluate the safety and effectiveness of ultrasound-guided pharmacopuncture for patients diagnosed with spinal diseases. A total of 600 patients, aged 19 to under 70 years, will be enrolled across six Korean medicine hospitals. Read more about this study
- Who is it for?
- Ages 19 to 69 years
- Conditions the study is for
- Spinal Disease, Neck Pain, Low Back Pain
- What is being tested?
- Ultrasound-guided Pharmacopuncture
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 600 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 29 Apr 2026to 31 Dec 2027
- How long will I take part?
- 8 Weeks
- 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 19 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult outpatients and inpatients (aged 19 to under 70) diagnosed with spinal diseases presenting with significant neck or low back pain (NRS ≥ 5). These patients are recruited from the clinical settings of six participating Korean medicine hospitals. They are individuals who are already scheduled to receive ultrasound-guided pharmacopuncture as part of their routine care plan, determined solely by the treating clinician's medical judgment.
Who may be able to join
- Patients diagnosed with spinal diseases (KCD codes M and S).
- Patients whose Numeric Rating Scale (NRS) score for the most predominant pain (neck pain with upper limb radiating pain OR low back pain with lower limb radiating pain) caused by spinal diseases is 5 or higher.
- Outpatients or inpatients scheduled to utilize an ultrasound scan during pharmacopuncture (the decision to perform ultrasound-guided pharmacopuncture is made according to the clinician's routine medical judgment, not for research purposes).
- Patients who voluntarily agree to participate in the clinical study and sign the informed consent form.
Who cannot join
- Patients who have difficulty completing the written informed consent form.
- Women who are pregnant, planning to become pregnant, or breastfeeding.
- Patients deemed inappropriate for study participation by the investigator due to severe underlying diseases (e.g., cancer or other malignant neoplasms) that may interfere with treatment effects or result interpretation.
- Individuals who are deemed unsuitable for participation in the clinical study by the researcher.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
South Korea6 sites, 6 recruiting
- Recruiting
Bucheon Jaseng Hospital of Korean Medicine
Bucheon-si, GGyeonggi-do, 14598
Jung-Hoon Han, KMD, +82-1577-0007, livercu17@jaseng.org
- Recruiting
Daejeon Jaseng Hospital of Korean Medicine
Daejeon, Daejeon, 35262
Sujin Kim, KMD, +82-1577-0007, naldo15@jaseng.org
- Recruiting
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-gu, 06110
Nam-Woo Lee, KMD, +82-1577-0007, kaktus0831@jaseng.co.kr
- Recruiting
Kyung Hee University Korean Medicine Hospital
Seoul, 02447
Jae-Heung Cho, KMD, +82-2-958-8114, vetkong95@hanmail.net
- Recruiting
Kyung Hee University Hospital at Gangdong
Seoul
Byung-Kwan Seo, KMD, +82-2-1577-5800, seohbk@hanmail.net
- Recruiting
School of Korean Medicine, Pusan National University
Yangsan
In Heo, +82-2-2222-2740, drheoin@pusan.ac.kr
About this study
Official title: Safety and Effectiveness of Ultrasound-guided Pharmacopuncture for Spinal Diseases: A Multi-center, Registry Study
This multi-center registry study aims to evaluate the safety and effectiveness of ultrasound-guided pharmacopuncture for patients diagnosed with spinal diseases. A total of 600 patients, aged 19 to under 70 years, will be enrolled across six Korean medicine hospitals. Eligible participants must have a pain Numeric Rating Scale (NRS) of 5 or higher for their most dominant spinal pain, which includes neck pain with upper extremity radiating pain, or low back pain with lower extremity radiating pain. As a non-interventional observational study, it will include patients who are already planned to receive ultrasound-guided pharmacopuncture as part of their routine clinical care. The primary outcome is the change in the most dominant spinal pain intensity measured by the NRS from baseline to 4 weeks. Secondary outcomes include functional disability evaluated using the Neck Disability Index (NDI) or Oswestry Disability Index (ODI), quality of life using the EQ-5D-5L, and patient satisfaction. Safety will be closely monitored by assessing all adverse events at every visit, evaluating their incidence, severity, and causality related to the procedure. Participants will be selected based on strict inclusion and exclusion criteria to ensure safety and consistency. Ethical standards including informed consent, data privacy, and ongoing safety monitoring will be rigorously upheld throughout the study.
Read the detailed description
This is a multi-center, non-interventional observational registry study designed to systematically collect and analyze real-world data on the safety and effectiveness of ultrasound-guided pharmacopuncture in clinical practice. The study will competitively recruit a total of 600 outpatients or inpatients from six participating institutions: Jaseng Hospital of Korean Medicine, Daejeon Jaseng Hospital of Korean Medicine, Bucheon Jaseng Hospital of Korean Medicine, Kyung Hee University Korean Medicine Hospital, Kyung Hee University Hospital at Gangdong, and Pusan National University Korean Medicine Hospital. Eligible participants must be adults aged 19 to under 70 years, diagnosed with a spinal disease corresponding to KCD M and S codes. Participants must report a dominant pain score of NRS 5 or higher for either neck pain and upper extremity radiating pain, or low back pain and lower extremity radiating pain. The decision to administer ultrasound-guided pharmacopuncture is made solely according to the clinician's routine judgment, not for the purpose of the study. Following enrollment, observational data will be collected at weeks 1, 2, 4, and 8. The primary effectiveness measure is the change in the NRS score for the dominant spinal pain from baseline (Week 0) to week 4. Secondary measures include changes in functional disability (assessed via NDI for neck pain or ODI for low back pain) and quality of life (EQ-5D-5L) evaluated at weeks 1, 2, 4, and 8. Additionally, a patient satisfaction survey regarding the treatment process, results, and preference will be conducted at week 4. To thoroughly assess the causality of any adverse events, details regarding the procedure method-such as pharmacopuncture type, target points, and maximum needle insertion length-along with concurrent treatments (acupuncture, herbal medicine, moxibustion, cupping, Chuna manual therapy, and physical therapy) will be meticulously recorded.
Safety is a primary focus of this registry; all adverse events occurring after the procedure will be assessed at every visit. These events will be documented including symptom details, onset dates, severity (using CTCAE), and causality with the procedure (using the WHO-UMC causality assessment system). Statistical analysis will utilize linear mixed models (LMM) to analyze changes in continuous outcomes over time, with adjustments made for covariates such as treatment frequency and the random effects of institutions and participants. Subgroup analyses will also be conducted based on the patients' primary symptoms. All ethical standards, including obtaining written informed consent, protecting data privacy, and securely storing case report forms, will be strictly maintained.
- Conditions
- Spinal Disease, Neck Pain, Low Back Pain, Radiculopathy
- Being tested
- Ultrasound-guided Pharmacopuncture
- Keywords
- Pharmacopuncture, Ultrasound-guided, Registry, Observational Study, Korean Medicine, Spinal Pain
- Medical subject headings
- Spinal Diseases, Neck Pain, Low Back Pain, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided PharmacopunctureProcedure or surgery
This is a procedure in which a Korean medicine doctor utilizes an ultrasound imaging device during pharmacopuncture injection for either of the following two purposes:
- Screening purpose: To pre-examine and identify the locations of high-risk structures, such as major nerves and blood vessels, prior to the injection.
- Guiding purpose: To observe the injection pathway and target tissues in real-time while administering the pharmacopuncture fluid into the acupoints and targets.
In this study, this intervention is not assigned for research purposes; rather, it is performed entirely according to the clinician's routine medical judgment and clinical care plan.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided Pharmacopuncture Cohort | This cohort consists of patients aged 19 to under 70 who have been diagnosed with spinal diseases (KCD codes M and S). Eligible participants must have a Numeric Rating Scale (NRS) score of 5 or higher for their most predominant pain, which may include neck pain with radiating pain to the upper limbs or low back pain with radiating pain to the lower limbs. These are patients who are already scheduled to receive ultrasound-guided pharmacopuncture as part of their routine clinical care plan. As this is a single-arm registry study, it comprises this single cohort without a separate control group. Receives: Procedure: Ultrasound-guided Pharmacopuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity : Numeric Rating Scale (NRS)
The NRS will evaluate the intensity of the most predominant pain (neck pain and upper limb radiating pain OR low back pain and lower limb radiating pain) caused by spinal diseases over the past 3 days. Patients select a number from 0 to 10, where 0 is 'no pain' and 10 is 'the worst pain imaginable'. Higher scores indicate a more severe level of pain (a worse outcome). The primary efficacy endpoint will compare the change in the NRS score from baseline to Week 4.
Measured: Baseline to Week 4
Secondary outcomes (6)
Change in Pain Intensity : Numeric Rating Scale (NRS) (Other Time Points)
The NRS will evaluate the intensity of the most predominant pain caused by spinal diseases over the past 3 days. Patients select a number from 0 to 10, where 0 is 'no pain' and 10 is 'the worst pain imaginable'. Higher scores indicate a more severe level of pain (a worse outcome).
Measured: Baseline, Week 1, Week 2, and Week 8
Change in Neck Disability Index (NDI)
The NDI is a 10-item questionnaire designed to assess the degree of disability in daily life. Each item is scored from 0 to 5, resulting in a total raw score ranging from a minimum of 0 to a maximum of 50. Higher scores indicate a more severe degree of disability (a worse outcome). This will be evaluated for patients whose primary symptom area is the cervical spine.
Measured: Baseline, Week 1, Week 2, Week 4, and Week 8
Change in Oswestry Disability Index (ODI)
The ODI is a 10-item questionnaire developed to evaluate the degree of disability for low back pain. Each question has 6 levels and is scored from 0 to 5, with the total score typically expressed as a percentage ranging from a minimum of 0% to a maximum of 100%. Higher scores indicate a more severe degree of disability (a worse outcome). This will be evaluated for patients whose primary symptom area is the lumbar spine.
Measured: Baseline, Week 1, Week 2, Week 4, and Week 8
Change in Quality of Life : EQ-5D-5L
The 5-Level EuroQol-5 Dimension (EQ-5D-5L) is a 5-item questionnaire evaluating mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It indirectly calculates the quality weight of a specific health state using pre-assigned preference scores. The calculated index value ranges from less than 0 (minimum) to 1.0 (maximum), where higher scores indicate a better health-related quality of life (a better outcome).
Measured: Baseline, Week 1, Week 2, Week 4, and Week 8
Patient Satisfaction Questionnaire
A 6-item survey to investigate patient satisfaction with the overall ultrasound-guided pharmacopuncture treatment process, results, preference compared to general pharmacopuncture, reasons for the choice, effects, and intention to recommend to others. The total score ranges from a minimum of 6 to a maximum of 30, where higher scores indicate greater patient satisfaction (a better outcome).
Measured: Week 4
Incidence of Adverse Events (AEs)
Safety will be evaluated by assessing and recording all adverse events that may occur after ultrasound-guided pharmacopuncture. The severity of adverse events will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE), which grades events on a severity scale from a minimum of 1 (mild) to a maximum of 5 (death). Higher grades indicate more severe adverse events (a worse outcome).
Measured: Every visit (from Baseline up to Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start29 Apr 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 8 Weeks
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- In-Hyuk Ha, Dr, Study director, Jaseng Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543692
- Sponsor's protocol ID
- JS-CT-2025-01
- Other IDs
- RS-2023-KH139336
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data collected during the study will be shared with other researchers, academic societies, and data processing institutions for secondary research purposes. This data sharing will be strictly limited to the data of participants who have provided separate, explicit written informed consent for the third-party provision and secondary utilization of their personal information. Furthermore, any provision of the anonymized data to a third party will only be conducted following formal review and approval by the Institutional Review Board (IRB).
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Ultrasound-guided Pharmacopuncture for Spinal Diseases: A Multi-center, Registry Study
- ClinicalTrials.gov ID
- NCT07543692
- Acronym / sponsor ID
- JS-CT-2025-01
- Conditions
- Spinal Disease, Neck Pain, Low Back Pain, Radiculopathy
- Keywords
- Pharmacopuncture, Ultrasound-guided, Registry, Observational Study, Korean Medicine, Spinal Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 29 Apr 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Apr 2026 (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.
This multi-center registry study aims to evaluate the safety and effectiveness of ultrasound-guided pharmacopuncture for patients diagnosed with spinal diseases. A total of 600 patients, aged 19 to under 70 years, will be enrolled across six Korean medicine hospitals. Eligible participants must have a pain Numeric Rating Scale (NRS) of 5 or higher for their most dominant spinal pain, which includes neck pain with upper extremity radiating pain, or low back pain with lower extremity radiating pain. As a non-interventional observational study, it will include patients who are already planned to receive ultrasound-guided pharmacopuncture as part of their routine clinical care. The primary outcome is the change in the most dominant spinal pain intensity measured by the NRS from baseline to 4 weeks. Secondary outcomes include functional disability evaluated using the Neck Disability Index (NDI) or Oswestry Disability Index (ODI), quality of life using the EQ-5D-5L, and patient satisfaction. Safety will be closely monitored by assessing all adverse events at every visit, evaluating their incidence, severity, and causality related to the procedure. Participants will be selected based on strict inclusion and exclusion criteria to ensure safety and consistency. Ethical standards including informed consent, data privacy, and ongoing safety monitoring will be rigorously upheld throughout the study.
Detailed description
This is a multi-center, non-interventional observational registry study designed to systematically collect and analyze real-world data on the safety and effectiveness of ultrasound-guided pharmacopuncture in clinical practice. The study will competitively recruit a total of 600 outpatients or inpatients from six participating institutions: Jaseng Hospital of Korean Medicine, Daejeon Jaseng Hospital of Korean Medicine, Bucheon Jaseng Hospital of Korean Medicine, Kyung Hee University Korean Medicine Hospital, Kyung Hee University Hospital at Gangdong, and Pusan National University Korean Medicine Hospital. Eligible participants must be adults aged 19 to under 70 years, diagnosed with a spinal disease corresponding to KCD M and S codes. Participants must report a dominant pain score of NRS 5 or higher for either neck pain and upper extremity radiating pain, or low back pain and lower extremity radiating pain. The decision to administer ultrasound-guided pharmacopuncture is made solely according to the clinician's routine judgment, not for the purpose of the study. Following enrollment, observational data will be collected at weeks 1, 2, 4, and 8. The primary effectiveness measure is the change in the NRS score for the dominant spinal pain from baseline (Week 0) to week 4. Secondary measures include changes in functional disability (assessed via NDI for neck pain or ODI for low back pain) and quality of life (EQ-5D-5L) evaluated at weeks 1, 2, 4, and 8. Additionally, a patient satisfaction survey regarding the treatment process, results, and preference will be conducted at week 4. To thoroughly assess the causality of any adverse events, details regarding the procedure method-such as pharmacopuncture type, target points, and maximum needle insertion length-along with concurrent treatments (acupuncture, herbal medicine, moxibustion, cupping, Chuna manual therapy, and physical therapy) will be meticulously recorded.
Safety is a primary focus of this registry; all adverse events occurring after the procedure will be assessed at every visit. These events will be documented including symptom details, onset dates, severity (using CTCAE), and causality with the procedure (using the WHO-UMC causality assessment system). Statistical analysis will utilize linear mixed models (LMM) to analyze changes in continuous outcomes over time, with adjustments made for covariates such as treatment frequency and the random effects of institutions and participants. Subgroup analyses will also be conducted based on the patients' primary symptoms. All ethical standards, including obtaining written informed consent, protecting data privacy, and securely storing case report forms, will be strictly maintained.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided Pharmacopuncture Cohort | – | Procedure: Ultrasound-guided PharmacopunctureThis cohort consists of patients aged 19 to under 70 who have been diagnosed with spinal diseases (KCD codes M and S). Eligible participants must have a Numeric Rating Scale (NRS) score of 5 or higher for their most predominant pain, which may include neck pain with radiating pain to the upper limbs or low back pain with radiating pain to the lower limbs. These are patients who are already scheduled to receive ultrasound-guided pharmacopuncture as part of their routine clinical care plan. As this is a single-arm registry study, it comprises this single cohort without a separate control group. |
Who may qualify
- Ages
- 19 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult outpatients and inpatients (aged 19 to under 70) diagnosed with spinal diseases presenting with significant neck or low back pain (NRS ≥ 5). These patients are recruited from the clinical settings of six participating Korean medicine hospitals. They are individuals who are already scheduled to receive ultrasound-guided pharmacopuncture as part of their routine care plan, determined solely by the treating clinician's medical judgment.
Key inclusion criteria (4 listed)
- Patients diagnosed with spinal diseases (KCD codes M and S).
- Patients whose Numeric Rating Scale (NRS) score for the most predominant pain (neck pain with upper limb radiating pain OR low back pain with lower limb radiating pain) caused by spinal diseases is 5 or higher.
- Outpatients or inpatients scheduled to utilize an ultrasound scan during pharmacopuncture (the decision to perform ultrasound-guided pharmacopuncture is made according to the clinician's routine medical judgment, not for research purposes).
- Patients who voluntarily agree to participate in the clinical study and sign the informed consent form.
Key exclusion criteria (4 listed)
- Patients who have difficulty completing the written informed consent form.
- Women who are pregnant, planning to become pregnant, or breastfeeding.
- Patients deemed inappropriate for study participation by the investigator due to severe underlying diseases (e.g., cancer or other malignant neoplasms) that may interfere with treatment effects or result interpretation.
- Individuals who are deemed unsuitable for participation in the clinical study by the researcher.
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 |
|---|---|---|
| Ultrasound-guided PharmacopunctureThis is a procedure in which a Korean medicine doctor utilizes an ultrasound imaging device during pharmacopuncture injection for either of the following two purposes: 1. Screening purpose: To pre-examine and identify the locations of high-risk structures, such as major nerves and blood vessels, prior to the injection. 2. Guiding purpose: To observe the injection pathway and target tissues in real-time while administering the pharmacopuncture fluid into the acupoints and targets. In this study, this intervention is not assigned for research purposes; rather, it is performed entirely according to the clinician's routine medical judgment and clinical care plan. | Procedure or surgery | Ultrasound-guided Pharmacopuncture Cohort |
Primary outcome
Change in Pain Intensity : Numeric Rating Scale (NRS)
Time frame: Baseline to Week 4
The NRS will evaluate the intensity of the most predominant pain (neck pain and upper limb radiating pain OR low back pain and lower limb radiating pain) caused by spinal diseases over the past 3 days. Patients select a number from 0 to 10, where 0 is 'no pain' and 10 is 'the worst pain imaginable'. Higher scores indicate a more severe level of pain (a worse outcome). The primary efficacy endpoint will compare the change in the NRS score from baseline to Week 4.
6 secondary outcomes
Change in Pain Intensity : Numeric Rating Scale (NRS) (Other Time Points)
Time frame: Baseline, Week 1, Week 2, and Week 8
Change in Neck Disability Index (NDI)
Time frame: Baseline, Week 1, Week 2, Week 4, and Week 8
Change in Oswestry Disability Index (ODI)
Time frame: Baseline, Week 1, Week 2, Week 4, and Week 8
Change in Quality of Life : EQ-5D-5L
Time frame: Baseline, Week 1, Week 2, Week 4, and Week 8
Patient Satisfaction Questionnaire
Time frame: Week 4
Incidence of Adverse Events (AEs)
Time frame: Every visit (from Baseline up to Week 8)
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 16 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data collected during the study will be shared with other researchers, academic societies, and data processing institutions for secondary research purposes. This data sharing will be strictly limited to the data of participants who have provided separate, explicit written informed consent for the third-party provision and secondary utilization of their personal information. Furthermore, any provision of the anonymized data to a third party will only be conducted following formal review and approval by the Institutional Review Board (IRB).
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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.
In-Hyuk Ha, Dr study director
Jaseng Medical Foundation
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Disease and Neck Pain, run by Jaseng Medical Foundation at 6 sites in South Korea.
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 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: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. 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 In-Hyuk Ha (+82-1577-0007, hanihata@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity : Numeric Rating Scale (NRS) (time frame: Baseline to Week 4). 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 16 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.