The Clinical Efficacy of Shengyu Decoction Combined With Lijin Manipulation in the Treatment of Knee Osteoarthritis Was Observed Based on Three-dimensional Gait Analysis System
试验速览
- 阶段
- 早期 1 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- The western Ontario and McMaster universities osteoarthritis index
研究概览
简要总结
Detailed Description Avoid duplicating information that will be entered or uploaded elsewhere in the record.
详细描述
This study aims to explore the efficacy of the Shengyu Decoction combined with manual therapy for the treatment of knee osteoarthritis (OA) using a clinical randomized controlled trial design. Additionally, based on three-dimensional gait analysis technology, the investigators will delve into the biomechanical mechanisms underlying the onset of knee OA and elucidate the mechanism of action of the Shengyu Decoction combined with manual therapy. This will further validate the clinical superiority of the Shengyu Decoction combined with manual therapy in the treatment of knee OA, providing strong support for reducing pain and improving knee function in patients with knee OA.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnostic criteria of Western medicine: Knee pain for at least 1 month, X-ray showing osteophyte formation, age ≥50 years, morning stiffness ≤30 min, and bone fricative sound.
- •TCM diagnostic criteria: Dull pain in the knee joint, flexion and extension limitations, pitching and side rotation unfavorability, slight activities slightly relieve pain, climate change aggravates symptoms, and repeated middle-aged and elderly patients, hidden onset, slow onset, slight local swelling of the knee joint, friction or clicking sound when moving, and severe cases may show muscle atrophy and joint deformity.
- •Radiographs showing joint space narrowing, bone hyperplasia, subchondral osteosclerosis, and osteophyte formation.
- •Patients who are between 45 and 85 years old.
- •Patients who can understand and provide informed consent.
- •Patients who are willing and able to undergo manual treatment for 1 course of treatment and cooperate with the doctor to complete the study.
排除标准
- •Patients who do not meet the diagnostic criteria for knee osteoarthritis established by the rheumatology society.
- •Severe knee pain with surgical indications (or X-ray grading standards reached level 4).
- •Pregnant or planning to become pregnant.
- •Patients who have participated in or are participating in other clinical trials within the last 3 months.
- •Patients who have received or are receiving other treatment methods such as drugs that affect the evaluation of efficacy within the past 3 months.
- •Patients with fractures, dislocation, skin damage, and severe infectious skin diseases within three weeks.
- •Patients with severe primary diseases such as liver, kidney, hematopoietic system, endocrine system, cardiovascular and cerebrovascular, nervous system, tuberculosis, joint malformations, tumors, and psychiatric patients and postoperative patients.
- •Patients who are unable to accurately evaluate the effectiveness and safety of treatment due to their medical condition.
研究组 & 干预措施
Combined treatment group
Traditional Chinese medicine combined with manipulation treatment：the Shengyu Decoction, which consists of the following herbs:
- Shu Di Huang 20 grams
- Bai Shao 15 grams
- Dang Gui 15 grams
- Chuan Xiong 8 grams
- Ren Shen 20 grams
- Huang Qi 18 grams One dose is taken per day, and a course of treatment consists of five weeks.
干预措施: Traditional Chinese medicine combined with manipulation treatment (Other)
Control group
Oral control group medication： Oral Celecoxib Capsules, 200mg per dose, once daily after lunch.
干预措施: Celecoxib capsule (Drug)
结局指标
主要结局
The western Ontario and McMaster universities osteoarthritis index
时间窗: up to 13 weeks
The WOMAC consists of a series of questions that capture the patient's perception of pain, stiffness, and physical function over the past week. It is scored on a numerical scale, with higher scores indicating greater impairment. The index is often used in clinical trials and epidemiological studies to measure changes in osteoarthritis symptoms and to assess the effectiveness of treatments.
次要结局
- Measurement of Gait Dynamics Parameters in Patients with Knee Osteoarthritis(up to 13 weeks)
- Gait Speed in meters per second(up to 13 weeks)
研究者
Liang Qiao
Clinical Professor
Xuhui Central Hospital, Shanghai