Safety and Effectiveness of Ultrasound-guided Pharmacopuncture for Spinal Diseases
2 other identifiers
observational
600
1 country
6
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2026
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2026
CompletedFirst Posted
Study publicly available on registry
April 22, 2026
CompletedStudy Start
First participant enrolled
April 28, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
May 1, 2026
April 1, 2026
1.7 years
April 15, 2026
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Change in Pain Intensity : Numeric Rating Scale (NRS) (Other Time Points)
Baseline, Week 1, Week 2, and Week 8
Change in Neck Disability Index (NDI)
Baseline, Week 1, Week 2, Week 4, and Week 8
Change in Oswestry Disability Index (ODI)
Baseline, Week 1, Week 2, Week 4, and Week 8
Change in Quality of Life : EQ-5D-5L
Baseline, Week 1, Week 2, Week 4, and Week 8
Patient Satisfaction Questionnaire
Week 4
- +1 more secondary outcomes
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Daejeon Jaseng Hospital of Korean Medicine
Daejeon, Daejeon, 35262, South Korea
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-gu, 06110, South Korea
Bucheon Jaseng Hospital of Korean Medicine
Bucheon-si, GGyeonggi-do, 14598, South Korea
Kyung Hee University Korean Medicine Hospital
Seoul, 02447, South Korea
Kyung Hee University Hospital at Gangdong
Seoul, South Korea
School of Korean Medicine, Pusan National University
Yangsan, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
In-Hyuk Ha, Dr
Jaseng Medical Foundation
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 8 Weeks
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2026
First Posted
April 22, 2026
Study Start
April 28, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- 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.
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).