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.

Inclusion Criteria:

1. Patients diagnosed with spinal diseases (KCD codes M and S).
2. 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.
3. 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).
4. Patients who voluntarily agree to participate in the clinical study and sign the informed consent form.

Exclusion Criteria:

1. Patients who have difficulty completing the written informed consent form.
2. Women who are pregnant, planning to become pregnant, or breastfeeding.
3. 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.
4. Individuals who are deemed unsuitable for participation in the clinical study by the researcher.

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.

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).

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.

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.