Safety and Effectiveness of Ultrasound-guided Pharmacopuncture for Spinal Diseases

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Low Back Pain; Neck Pain; Radiculopathy; Spinal Disease
• Intervention / Treatment: Procedure: Ultrasound-guided Pharmacopuncture

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 Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: In-Hyuk Ha; Phone Number: +82-1577-0007; Email: hanihata@gmail.com

Study Locations

• South Korea
  • Seoul, South Korea, 02447
    • Kyung Hee University Korean Medicine Hospital
    • Contact: Jae-Heung Cho, KMD; Phone Number: +82-2-958-8114; Email: vetkong95@hanmail.net
  • Seoul, South Korea
    • Kyung Hee University Hospital at Gangdong
    • Contact: Byung-Kwan Seo, KMD; Phone Number: +82-2-1577-5800; Email: seohbk@hanmail.net
  • Yangsan, South Korea
    • School of Korean Medicine, Pusan National University
    • Contact: In Heo; Phone Number: +82-2-2222-2740; Email: drheoin@pusan.ac.kr
  • Daejeon
    • Daejeon, Daejeon, South Korea, 35262
      • Daejeon Jaseng Hospital of Korean Medicine
      • Contact: Sujin Kim, KMD; Phone Number: +82-1577-0007; Email: naldo15@jaseng.org
  • GGyeonggi-do
    • Bucheon-si, GGyeonggi-do, South Korea, 14598
      • Bucheon Jaseng Hospital of Korean Medicine
      • Contact: Jung-Hoon Han, KMD; Phone Number: +82-1577-0007; Email: livercu17@jaseng.org
  • Gangnam-gu
    • Seoul, Gangnam-gu, South Korea, 06110
      • Jaseng Hospital of Korean Medicine
      • Contact: Nam-Woo Lee, KMD; Phone Number: +82-1577-0007; Email: kaktus0831@jaseng.co.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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).	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).	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).	Every visit (from Baseline up to Week 8)

Collaborators and Investigators

• Sponsor: Jaseng Medical Foundation
• Investigators: Study Director: In-Hyuk Ha, Dr, Jaseng Medical Foundation

Study record dates

Study Major Dates

• Study Start (Estimated): April 28, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Ultrasound-guided; Observational Study; Registry; Korean Medicine; Pharmacopuncture; Spinal Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Bone Diseases; Musculoskeletal Diseases; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Radiculopathy; Low Back Pain; Neck Pain; Spinal Diseases
• Other Study ID Numbers: JS-CT-2025-01; RS-2023-KH139336 (Other Grant/Funding Number: Korea Health Industry Development Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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).
• IPD Sharing 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.

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No