Effectiveness and Safety of Pharmacopuncture Therapy for Chronic Lumbar Radiculopathy: A Multicenter, Pragmatic, Randomized, Comparative Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 4
- 主要终点
- Leg pain Numeric Rating Scale, NRS
研究概览
简要总结
A pragmatic clinical study to compare the effectiveness of pharmacopuncture and physical therapy strategies in patients with chronic lumbar radiculopathy
详细描述
This multicenter, pragmatic, randomized, comparative clinical trial aims to evaluate the effectiveness and safety of pharmacopuncture in patients with chronic lumbar radiculopathy. A total of 92 participants with chronic lumbar radiculopathy will be recruited from four traditional Korean medicine hospitals: Recruitment will follow a competitive enrollment scheme. Participants will be randomly assigned to one of two treatment strategy groups: a pharmacopuncture group (n = 46) and a physical therapy group (n = 46). As a pragmatic trial, the specific methods of pharmacopuncture and physical therapy will not be predetermined. Instead, treatment methods will be determined by the clinical judgment of the Korean medicine doctor according to each patient's individual condition. All administered treatments will be recorded in the patients' medical records and the Case Report Form (CRF) for later comparison.
The primary objective of this study is to assess the comparative effectiveness of pharmacopuncture against physical therapy in managing chronic lumbar radiculopathy symptoms in a real-world clinical setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Inclusion Criteria:
- •Persistent sciatica symptoms lasting for more than 3 months.
- •Presence of at least one of the following signs in one or both lower extremities: Muscle weakness / Dermatomal sensory disturbance (hypoesthesia, dysesthesia, tingling, or pain) / Decreased reflexes / Radiating pain aggravated by the Straight Leg Raising (SLR) test
- •Numeric Rating Scale (NRS) score of 4 or higher for leg pain.
- •Aged between 19 and 70 years.
- •Provided written informed consent to participate in the clinical trial.
排除标准
- •Diagnosed with serious conditions that may cause lower limb radiating pain (e.g., spinal metastasis of cancer, acute vertebral fracture, or dislocation).
- •Presence of progressive neurological deficits or severe neurological symptoms.
- •Pain originating from non-spinal soft tissue disorders (e.g., tumors, fibromyalgia, rheumatoid arthritis, gout).
- •Presence of chronic diseases that may interfere with treatment outcomes or interpretation (e.g., stroke, myocardial infarction, renal disease, diabetic neuropathy, dementia, epilepsy).
- •Current use of steroids, immunosuppressants, psychiatric medications, or other drugs that may affect study outcomes.
- •Inappropriate or unsafe conditions for pharmacopuncture, including bleeding disorders, anticoagulant therapy, or severe diabetes with high infection risk.
- •Use of analgesic medications such as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), or receipt of acupuncture, pharmacopuncture, or physical therapy within the past 7 days.
- •Pregnant, planning to become pregnant, or currently breastfeeding.
- •Within 3 months post-lumbar spine surgery.
- •Participation in another clinical trial within the past month, or planned participation in another clinical trial (including follow-up period) within 6 months from the screening date.
- •Difficulty in completing the informed consent process.
- •Any other condition that the investigator deems inappropriate for participation in the clinical trial.
研究组 & 干预措施
Pharmacopuncture group
- Acupoints:
The selection of acupoints, needling depth, and other procedural details will be determined based on the clinical judgment of the Korean medicine doctor, taking into account the patient's symptoms, diagnostic imaging findings, and progress. All selected acupoints used for the treatment of chronic lumbar radiculopathy will be documented, and only those listed by the World Health Organization (WHO) will be used. 2. Pharmacopuncture Solution:
The type of pharmacopuncture solution and the dosage administered will be selected at the discretion of the practitioner performing the pharmacopuncture, based on their clinical judgment. The type and total volume (in milliliters) of the pharmacopuncture solution used will be recorded for retrospective chart review. The dosage will range from 0.1 cc to 10.0 cc, depending on the clinician's decision. The selection of pharmacopuncture solutions will be limited to those already in clinical use at each participating institution.
干预措施: Pharmacopuncture (Procedure)
Physical Therapy Group
As this is a pragmatic clinical trial, the choice of physical therapy modality, treatment area, and treatment duration will be determined based on the clinical judgment of the physician, taking into account the patient's symptoms, imaging findings, and clinical progress. All types, frequencies, and sites of physical therapy prescribed and administered will be recorded. To improve symptoms and conditions related to lumbar radiculopathy, any mechanical physical therapy modality currently used in actual clinical practice will be permitted. Examples include Interference Current Therapy (ICT) and Transcutaneous Electrical Nerve Stimulation (TENS).
干预措施: Physical Therapy (Procedure)
结局指标
主要结局
Leg pain Numeric Rating Scale, NRS
时间窗: Week 7
Change from baseline to Week 7 on the Numeric Rating Scale of Leg pain
次要结局
- Leg and low back pain Numeric Rating Scale(Week 1,2,3,4,5,6,7,13)
- Leg and low back pain Visual Analogue Scale(Week 1,2,3,4,5,6,7)
- Oswestry Disability Index(Week 1,7,13)
- Roland-Morris Disability Questionnaire(Week 1,7,13)
- Patient Global Impression of Change(Week 7,13)
- Health-related Quality of Life Instrument with 8 Items(Week 1,7,13)
- 5-Level EuroQol-5 Dimension(Week 1,7,13)
- Adverse events(Week 1,2,3,4,5,6,7,13)