Comparison of the Efficacy of Ultrasound-Guided Injections of Saline, High-Concentration Dextrose, and Ligament Repair Agents for the Treatment of Medial Collateral Ligament Pathology in Degenerative Knee Osteoarthritis: A Randomized Double-Blind Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 51
- 主要终点
- Pain Reduction Using WOMAC Osteoarthritis Index
研究概览
简要总结
The goal of this clinical trial is to evaluate the effectiveness of STABHA, high-concentration glucose water, and saline injections in treating knee osteoarthritis with medial collateral ligament lesions. This prospective, double-blind, randomized trial will recruit 51 patients from the Shin Kong Hospital Rehabilitation Department.
The main questions it aims to answer are:
- Do STABHA or high-concentration glucose water injections provide better pain relief and improved knee function compared to saline?
- What side effects do participants experience with these treatments?
Participants will be randomly divided into three groups: STABHA, high-concentration glucose water, and saline. In addition to routine intra-articular hyaluronic acid injections, each group will receive two ultrasound-guided injections of their assigned treatment into the medial collateral ligament of the knee, with a two-week interval. All participants will also undergo a 4-week physical therapy program.
Participants will:
- Receive two ultrasound-guided injections over two weeks.
- Undergo 4 weeks of physical therapy.
- Return for follow-up assessments at 1 and 3 months, including the WOMAC osteoarthritis index, pain score, KOOS knee outcome score, knee range of motion, and knee ultrasound examination.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients should fulfill the following criteria:
- •Age between 45 to 80 years old.
- •Meet at least three of the six American College of Rheumatology (ACR) criteria, including age over 50 years, morning stiffness less than 30 minutes, crepitus in passive knee movements, bony tenderness, bony enlargement, and no palpable warmth.
- •Radiologic grading of 2 or 3 according to Kellgren-Lawrence criteria.
- •Evidence of medial collateral ligament (MCL) pathology with incomplete injuries (grade I or II).
- •Willing to receive prolotherapy treatment.
- •Willing and able to complete all follow-ups and assessments in the randomized double-blind trial.
排除标准
- •The exclusion criteria are:
- •Severe systemic disorders including cancer, uncontrolled diabetes mellitus, sepsis, or cardiopulmonary diseases.
- •History of anticoagulation therapy, knee injection over the past three months.
- •History of knee surgery or candidates for knee arthroplasty.
- •History of intolerance to prolotherapy.
- •Infectious arthritis, inflammatory joint diseases, joint dysplasia.
- •Body Mass Index (BMI) greater than 35 kg/m
- •Complete tear of medial collateral ligament under ultrasound.
- •Fracture or other causes of knee pain instead of osteoarthritis.
研究组 & 干预措施
Saline Injection
Participants will receive two ultrasound-guided saline injections into the medial collateral ligament of the knee at a 2-week interval.
干预措施: Saline Injection (Other)
STABHA Injection
Participants will receive two ultrasound-guided STABHA injections into the medial collateral ligament of the knee at a 2-week interval.
干预措施: STABHA Injection (Biological)
High-Concentration Glucose Water Injection
Participants will receive two ultrasound-guided high-concentration glucose water injections into the medial collateral ligament of the knee at a 2-week interval.
干预措施: High-Concentration Glucose Water Injection (Other)
结局指标
主要结局
Pain Reduction Using WOMAC Osteoarthritis Index
时间窗: Baseline, 1 month, and 3 months post-intervention
The primary outcome will assess the change in pain scores using the WOMAC Osteoarthritis Index at baseline, 1 month, and 3 months after the treatment intervention
次要结局
- Knee Range of Motion(Baseline, 1 month, and 3 months post-intervention)
- KOOS Knee Outcome Score(Baseline, 1 month, and 3 months post-intervention)
研究者
Chen Ting-an
Attending Physician
Shin Kong Wu Ho-Su Memorial Hospital