Clinical Eficacy of Extracorporeal Shock Wave Therapy on Patellar Tendon Combined With Center of Coordination Point in the Fascial Manipulation for Patellar Tendinitis:A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- the change in pain intensity over a follow-up period of 3 months after treatment
研究概览
简要总结
This study is a randomized controlled trial. Patients diagnosed with patellar tendinitis and meeting the criteria for shockwave therapy were included. Relevant clinical data and assessments were collected upon enrollment and after obtaining informed consent. Randomization was performed using a random number table: the experimental and control groups. Based on the group assignments, the experimental group received either patellar tendon combined with fascial therapy coordinated centre point shock wave treatment, while the control group received only shockwave therapy for the patellar tendon. The treatments were performed by a rehabilitation therapist with extensive clinical experience. Data on participant pain and knee joint function were collected using the Visual Analogue Scale (VAS) and the Lysholm Knee Scoring System at baseline and on the day following completion of all treatments. Data on the thickness of the patellar tendon on the affected side of the knee were collected using a portable musculoskeletal ultrasound imaging system. Follow-up assessments and data collection on pain and knee joint function were conducted using the VAS and Lysholm Knee Scoring Scale one month and three months after the completion of all treatments to compare changes before and after treatment and to evaluate whether patellar tendon combined with fascial therapy coordinated centre point shock wave therapy has superior short-term and medium-term maintenance efficacy for patellar tendinitis compared with simple patellar tendon shock wave therapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged between 18 and 45 yearsWillingness to sign an informed consent form and ability to cooperate with the treatment and follow-up aspects of this study.
- •Meeting the diagnostic criteria for patellar tendinitis as outlined in "Practical Sports Medicine" (2023 edition)
- •Knee joint pain with a VAS score of ≥3 and ≤7
- •No other orthopedic or neurological conditions that could affect lower limb strength or mobility
- •Willingness to sign an informed consent form and ability to cooperate with the treatment and follow-up aspects of this study
排除标准
- •History of knee joint surgery within the past year
- •Presence of knee pain due to other causes, or conditions that affect the knee joint or impact its function (including but not limited to: transient synovitis, bone tuberculosis, bone tumors, acute traumatic arthritis, suppurative arthritis, rheumatoid arthritis, metabolic bone diseases, psoriatic arthritis, gouty arthritis, bone necrosis, ankylosing spondylitis, or active infections)
- •Presence of chronic knee pain caused by other reasons (such as post-herpetic neuralgia, osteoporosis, etc.)
- •Contraindications for shockwave therapy, such as deep venous thrombosis in the lower extremities, bleeding disorders or coagulation dysfunction, pregnancy, cognitive dysfunction, etc.
- •Presence of cancerous tumors, severe bronchiectasis, acute suppurative inflammation, high fever, active pulmonary tuberculosis, heart failure, severe anemia, cerebrovascular diseases, or the presence of a cardiac pacemaker implanted in the body
- •Inability to participate in the trial due to other health issues, such as sudden severe trauma, sudden severe infectious diseases, etc.
研究组 & 干预措施
Experimental Group
Extracorporeal shockwave therapy was performed not only on the patellar tendon but also at the coordination centre points marked after assessment by a fascia therapist .
干预措施: Extracorporeal Shock Wave Therapy on Patellar Tendon Combined with Center of Coordination Point (Procedure)
Control Group
Extracorporeal shockwave therapy was performed only on the patellar tendon .
干预措施: Extracorporeal Shock Wave Therapy only on Patellar Tendon (Procedure)
结局指标
主要结局
the change in pain intensity over a follow-up period of 3 months after treatment
时间窗: Baseline and Day 105
Determine the medium-term maintenance effect of pain relief before and after treatment. Use the Visual Analogue Scale (VAS) to quantitatively assess changes in pain intensity at the 3-month follow-up after treatment. At baseline and at 3 months after the completion of all treatments, the assessment is carried out using the Visual Analogue Scale by a trained therapist who is not involved in the intervention treatment or data analysis.
次要结局
- The changes in pain intensity measured both on the day following treatment and during the follow-up period of one month(Baseline, Day 15 and Day 45)
- the changes in the Lysholm knee scoring scale after treatment, as well as during follow-up visits after one and three months.(Baseline, Day 15, Day 45 and Day 105)
- the change in the thickness of the patellar tendon on the day following treatment(Baseline and Day 15)