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NCT Number: NCT07543692

Safety and Effectiveness of Ultrasound-guided Pharmacopuncture for Spinal Diseases

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.

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Key information

Conditions

Spinal Disease Back Pain Bone Diseases Low Back Pain Musculoskeletal Diseases Neck Pain Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Radiculopathy Signs and Symptoms Spinal Diseases

Age range

19 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Daejeon Jaseng Hospital of Korean Medicine, Daejeon, South Korea

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About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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:

  • 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.

Primary outcomes

  1. Change in Pain Intensity : Numeric Rating Scale (NRS)

    Time frame: Baseline to Week 4

    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.

Secondary outcomes

  1. Change in Pain Intensity : Numeric Rating Scale (NRS) (Other Time Points)

    Time frame: Baseline, Week 1, Week 2, and Week 8

    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).

  2. Change in Neck Disability Index (NDI)

    Time frame: Baseline, Week 1, Week 2, Week 4, and Week 8

    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.

  3. Change in Oswestry Disability Index (ODI)

    Time frame: Baseline, Week 1, Week 2, Week 4, and Week 8

    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.

  4. Change in Quality of Life : EQ-5D-5L

    Time frame: Baseline, Week 1, Week 2, Week 4, and Week 8

    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).

  5. Patient Satisfaction Questionnaire

    Time frame: Week 4

    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).

  6. Incidence of Adverse Events (AEs)

    Time frame: Every visit (from Baseline up to Week 8)

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

In-Hyuk Ha

CONTACT

[email protected]

+82-1577-0007

Sponsors and collaborators

Lead sponsor

Jaseng Medical Foundation

Other

Registry information

Official study title

Safety and Effectiveness of Ultrasound-guided Pharmacopuncture for Spinal Diseases: A Multi-center, Registry Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 22, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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