Clinical Research of Comparative Effectiveness of Pharmacopuncture Therapy and Acupuncture Therapy for Chronic Neck Pain: A Pragmatic Randomized Strategy Comparative Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 6
- 主要终点
- Neck pain Numeric Rating Scale, NRS
研究概览
简要总结
A pragmatic clinical study to compare the effectiveness of pharmacopuncture and acupuncture treatment strategies in patients with chronic neck pain
详细描述
This study aims to confirm the comparative effectiveness of pharmacopuncture by conducting a pragmatic randomized controlled clinical trial with 128 patients suffering from chronic neck pain. The trial will compare patients treated with a pharmacopuncture-based strategy (64 patients) to those treated with an acupuncture-based strategy (64 patients). As this is a pragmatic clinical trial, participants will be randomly assigned to either the pharmacopuncture or acupuncture groups. However, the specific methods of pharmacopuncture and acupuncture to be used will not be predetermined. Instead, they will be determined based on the clinical judgment of the traditional Korean medicine doctor according to the patient's condition. All methods used will be recorded in the CRF (Case Report Form).
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
- •Patients with neck pain persisting for more than 3 months
- •Patients with a Numeric Rating Scale (NRS) score of 5 or higher for neck pain
- •Patients aged between 19 and 70 years
- •Patients who agree to participate in the clinical study and provide a written informed consent form
排除标准
- •Patients diagnosed with serious specific diseases that could be the cause of neck pain (e.g., spinal metastasis of tumors, acute fractures, and spinal dislocations)
- •Patients exhibiting progressive neurological deficits or severe neurological symptoms
- •Patients whose pain originates from soft tissue disorders rather than the spine (e.g., tumors, fibromyalgia, rheumatoid arthritis, gout)
- •Patients with other chronic diseases that could interfere with the interpretation of treatment effects or outcomes (e.g., stroke, myocardial infarction, kidney disease, diabetic neuropathy, dementia, epilepsy)
- •Patients currently taking steroids, immunosuppressants, psychiatric medications, or other drugs that could affect the study results
- •Patients for whom pharmacopuncture treatment is inappropriate or unsafe: those with bleeding disorders, those undergoing anticoagulant therapy, and severe diabetic patients with infection risks
- •Patients who have taken medications that could affect pain (e.g., Non-Steroidal Anti-Inflammatory Drugs, NSAIDs) or received pharmacopuncture, acupuncture, or physical therapy within the past week
- •Pregnant women, those planning to become pregnant, or those currently breastfeeding
- •Patients who have undergone cervical spine surgery within the past 3 months
- •Patients who have not completed participation in another clinical study within the past month or plan to participate in another clinical study during the study participation and follow-up period within 6 months from the date of selection
- •Patients who find it difficult to provide informed consent for participation
- •Other cases where the researcher deems participation in the clinical study to be difficult
研究组 & 干预措施
Pharmacopuncture group
- Acupoints: The selection of acupoints, depth of insertion, and other procedural details are determined based on the clinical judgment of the physicians according to the participant's symptoms, diagnostic imaging, and degree of improvement. Acupoints may include GB20, GB21, BL11, and EX-B2. However, these acupoints are not restrictive; any acupoints used for the treatment of chronic neck pain will be documented.
- Pharmacopuncture: The type and dosage of the pharmacopuncture solution used during treatment will be selected based on the clinical judgment of the physicians performing the pharmacopuncture. The types of pharmacopuncture solutions and the total amount administered will be recorded. The choice will be based on the participant's symptoms and the clinical judgment within the range of pharmacopuncture solutions currently used in clinical practice at the trial institution, without adding new solutions specifically for this study.
干预措施: Pharmacopuncture (Procedure)
Acupuncture group
The selection of acupoints, depth of insertion, and other procedural details are to be determined based on the clinical judgment of the physicians according to the participant's symptoms, diagnostic imaging, and degree of improvement. Acupoints may include sites such as GB21, SI9, GB20, GV14, and distal points like SI3. The number of needles used can range from 5 to 30. All acupoints treated during the procedure are to be documented.
干预措施: Acupuncture (Procedure)
结局指标
主要结局
Neck pain Numeric Rating Scale, NRS
时间窗: Week 5
Change from baseline to Week 5 on the Numeric Rating Scale of neck pain
次要结局
- Neck and arm pain Visual Analogue Scale(Week 1,2,3,4,5)
- Patient Global Impression of Change(Week 5,8,12)
- Northwick Park Questionnaire(Week 1,5,8,12)
- Neck and arm pain Numeric Rating Scale(Week 1,2,3,4,5,8,12)
- Neck disability index(Week 1,5,8,12)
- Health-related Quality of Life Instrument with 8 Items(Week 1,5,8,12)
- 5-Level EuroQol-5 Dimension(Week 1,5,8,12)
- Adverse events(Week 1,2,3,4,5,8,12)