Safety and Effectiveness of Ultrasound-guided Pharmacopuncture for Spinal Diseases

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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: 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

Первичные конечные точки

• Change in Pain Intensity : Numeric Rating Scale (NRS) [Срок оценки: Baseline to Week 4]

Вторичные конечные точки (6)

• Change in Pain Intensity : Numeric Rating Scale (NRS) (Other Time Points) [Срок оценки: Baseline, Week 1, Week 2, and Week 8]
• Change in Neck Disability Index (NDI) [Срок оценки: Baseline, Week 1, Week 2, Week 4, and Week 8]
• Change in Oswestry Disability Index (ODI) [Срок оценки: Baseline, Week 1, Week 2, Week 4, and Week 8]
• Change in Quality of Life : EQ-5D-5L [Срок оценки: Baseline, Week 1, Week 2, Week 4, and Week 8]
• Patient Satisfaction Questionnaire [Срок оценки: Week 4]
• Incidence of Adverse Events (AEs) [Срок оценки: Every visit (from Baseline up to Week 8)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

South Korea · 6 центров

• Daejeon Jaseng Hospital of Korean Medicine — Daejeon
• Jaseng Hospital of Korean Medicine — Seoul
• Bucheon Jaseng Hospital of Korean Medicine — Bucheon-si
• Kyung Hee University Korean Medicine Hospital — Seoul
• Kyung Hee University Hospital at Gangdong — Seoul
• School of Korean Medicine, Pusan National University — Yangsan

Идентификаторы

NCT: NCT07543692 · JS-CT-2025-01 · RS-2023-KH139336

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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