Safety and Effectiveness of Ultrasound-guided Pharmacopuncture for Spinal Diseases

Sponsor
Jaseng Medical Foundation
Study ID
NCT07543692
Status
Recruiting
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Conditions

  • Low Back Pain
  • Neck Pain
  • Radiculopathy
  • Spinal Disease

Eligibility Criteria

Sex
ALL
Age
19 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

  • Ultrasound-guided Pharmacopuncture — PROCEDURE
    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.

Study Details

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.

Key Dates

First listed
Apr 22, 2026
Start date
Apr 29, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
600 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Change in Pain Intensity : Numeric Rating Scale (NRS) [ Time Frame: Baseline to Week 4 ]

Central Contacts

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