Biomechanically Based Fu's Subcutaneous Needling Treatment for Senile Keen Osteoarthritis: Protocol For a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Change from Baseline in the visual analogue scale (VAS) (0-100 mm) at the 14th day after receiving treatment.
研究概览
简要总结
The goal of this clinical trial is to compare FSN with oral Nonsteroidal Antiinflammatory Drugs (NSAIDs) in pain relief and improvement in knee function among elder people, the main questions it aims to answer are:
Q1: Compared with the positive drug (celecoxib), whether FSN is more or at least as effective for pain relief and improvement in knee function in elder people with knee arthritis.
Q2: From the biomechanical point of view, what is the mechanism by which FSN plays a therapeutic role in knee osteoarthritis (KOA)?
Participants will:
- Will be randomly assigned to 2 groups. There will be 30 participants in each group.
- A group of patients will receive FSN monotherapy, while the other group will receive oral celecoxib and pantoprazole. Each patient will receive a 2-week course of treatment.
- Visual analogue scale (VAS), WOMAC, knee range of motion (ROM), gait analysis, and musculoskeletal ultrasonography (US) of lower extremity muscles will be assessed during treatment and in the follow-up.
Researchers will compare FSN and celecoxib to see if FSN has better, or at least equivalent, efficacy than celecoxib, which is commonly used in clinical practice.
详细描述
This study was a randomised, parallel-controlled, single-center prospective clinical study, which included 60 participants, with an FSN group (n=30) and a drug group (n=30). All patients will give informed consent before participation and the trial is initiated after approval. The Fu's subcutaneous needling(FSN) group underwent FSN treatment 3 times a week for 2 weeks, while the drug group received oral celecoxib 0.2 g/day for 2 weeks, with a follow-up period of 2 weeks after the completion of treatment. The primary outcome will be the visual analog scale（VAS）after two weeks of treatment. The secondary outcomes will be self-reported knee stiffness using the WOMAC Index, joint active range of motion test, three-dimensional gait analysis, and Shear wave elastic imaging technology analysis in lower limb muscles. The results of this trial will be disseminated through publication in peer-reviewed journals.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 60-80 years old.
- •Clinical diagnosis of knee osteoarthritis.
- •Kellgren-Lawrence grade 1-
- •Knee pain score > 3 on an 10-point numerical rating scale (VAS).
- •Having no obvious deformity.
- •Having not taken other medication and other modalities of treatment in the last 3 months.
- •Voluntary and capable of signing the informed consent form.
排除标准
- •Non-primary knee osteoarthritis, such as gouty arthritis and hemophilic arthritis, is caused by serious violence and the structure of the knee joint is damaged.
- •Patients with other diseases that may cause lower limb pain, such as lumbar disc herniation and lumbar spinal stenosis.
- •Patients with lower extremity vascular disease.
- •Having a history of knee surgery in the past 6 months.
- •Receiving drugs related to knee osteoarthritis or the internal and external treatment of traditional Chinese Medicine in the past 3 months.
- •Severe systemic or lower limb local skin disease.
- •Contraindications to NSAIDs, such as after coronary artery bypass grafting, active peptic ulcer, severe heart failure, etc.
- •With any unstable medical or psychiatric illness.
研究组 & 干预措施
FSN group
Fu's subcutaneous needling (FSN) is a new type of acupuncture. Patients in the FSN Group only received FSN treatment, without other interventions such as oral drugs or topical drugs.
干预措施: Fu's Subcutaneous Needling (Device)
Drug Group
Celecoxib is a member of Nonsteroidal Antiinflammatory Drugs (NSAIDs) and the most commonly used treatment for knee osteoarthritis. Patients in the drug group received only oral celecoxib, no other oral or topical drugs, and no other physical therapies.
干预措施: Celecoxib (Drug)
结局指标
主要结局
Change from Baseline in the visual analogue scale (VAS) (0-100 mm) at the 14th day after receiving treatment.
时间窗: Baseline and the 14th day after the start of treatment
Visual analogue scale (VAS) is used to assess pain. A "0" indicates no pain or no limitation of function and gets worse as the value increases, and a "10" indicates severe pain (refractory to analgesic medication) or extreme limitation of function
次要结局
- Change from Baseline in The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at the 7th day, the 14th day, the 28th day and 42th day after the start of treatment.(Baseline and the 7th day, the 14th day, the 28th day and the 42th day after the start of treatment.)
- Change from Baseline in the visual analogue scale (VAS) (0-100 mm) at the 7th day, the 28th day and 42th day after the start of treatment.(Baseline and the 7th day, the 28th day and the 42th day after the start of treatment)
- Change from Baseline in the active range of motion (ROM) of the knee at the 7th day,the 14th day,the 28th day and 42th day after the start of treatment.(Baseline and the 7th day, the 14th day, the 28th day and the 42th day after the start of treatment)
研究者
Jian Sun
Vice Dean of College
Guangdong Provincial Hospital of Traditional Chinese Medicine