An observational study in Spinal Disease, Neck Pain and Low Back Pain, sponsored by Jaseng Medical Foundation. Recruiting at 6 sites in South Korea. Open to participants aged 19 Years to 69 Years. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Jaseng Medical Foundation · Observational
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.
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.
174 studies on the registry are indexed under Spinal Diseases; 39 are open to participants now.
This study's planned enrollment of 600 is above the median of 117 across 64 observational studies indexed under Spinal Diseases.
Browse Spinal Diseases studies →Jaseng Medical Foundation is the lead sponsor of 69 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Ultrasound-guided Pharmacopuncture
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: 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.
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.
Time frame: Baseline to Week 4
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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Every visit (from Baseline up to Week 8)
Plan to share: 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).
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: De-identified individual participant data (IPD) and supporting information will become available 6 months after the publication of the primary study results. The data will remain accessible for a period of 3 years from the date of publication.
Access criteria: Who can access: Researchers who provide a methodologically sound proposal for secondary research purposes. What will be available: De-identified individual participant data (IPD) of those who explicitly consented to data sharing, along with the study protocol, statistical analysis plan, and blank informed consent form. How to access: Proposals should be directed to the principal investigator or the corresponding author. To gain access, researchers must sign a data access agreement, and the data provision must be officially reviewed and approved by the Institutional Review Board (IRB) of the institution holding the data.
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Dec 2027, 20 months after the start.
Of 32 observational studies under Spinal Diseases, half reached primary completion within 82 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 112. This study's planned 20 months is below that.
How these figures are worked out, and which studies are left out of them.
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