A Randomized Controlled Trial Evaluating the Influence of Physical Therapy, Shockwave Therapy, Platelet Rich Plasma or Combined Treatment in the Management of Midportion Achilles Tendinopathy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Victorian Institute of Sport Assessment-Achilles (VISA-A)
研究概览
简要总结
Midportion Achilles tendinopathy is a common cause of pain and functional limitation in both athletes and the general population. Progressive tendon loading programs are considered first-line treatment but do not lead to satisfactory outcomes in all patients. Extracorporeal shockwave therapy (ESWT) and platelet-rich plasma (PRP) injections are commonly used interventions for refractory symptoms, yet evidence supporting their combined use is limited particularly in treating Achilles tendon disorders.
This randomized controlled trial will evaluate the effectiveness of a standardized exercise program alone or in combination with PRP injection, ESWT, or both therapies in active adults with midportion Achilles tendinopathy. Participants will be randomized to one of four treatment groups and followed for six months. The primary outcome will assess changes in Achilles tendon symptoms and function using the Victorian Institute of Sport Assessment-Achilles (VISA-A) score. Secondary outcomes will include patient-reported outcomes, physical function testing, ultrasound tendon structure measures, and gait biomechanics.
详细描述
Midportion Achilles tendinopathy (Mid-AT) is characterized by pain, stiffness, and impaired function resulting from a failed tendon healing response. Progressive loading exercise programs such as the Silbernagel protocol represent the current standard treatment and provide meaningful improvement for many individuals. However, approximately 40% of patients continue to experience persistent symptoms despite rehabilitation.
Extracorporeal shockwave therapy (ESWT) and platelet-rich plasma (PRP) injections are increasingly used in clinical practice to address refractory symptoms. ESWT is proposed to stimulate tissue healing through mechanotransduction and has demonstrated improved outcomes when combined with exercise therapy in some studies. PRP contains concentrated autologous growth factors that may enhance tendon healing through stimulation of extracellular matrix production, angiogenesis, and collagen synthesis.
Despite increasing clinical use, there remains limited evidence evaluating the comparative or combined effects of PRP and ESWT in the treatment of Achilles tendinopathy. Furthermore, few trials have evaluated these therapies within a standardized rehabilitation framework.
The purpose of this randomized controlled trial is to evaluate the effectiveness of exercise therapy alone compared with exercise therapy combined with PRP injection, ESWT, or both interventions in individuals with chronic midportion Achilles tendinopathy. Participants will be randomized to one of four treatment groups: exercise with sham procedures (control), exercise plus PRP injection, exercise plus ESWT, or exercise combined with PRP and ESWT. Participants will be followed for six months to evaluate patient-reported outcomes, tendon structure using ultrasound, physical function testing, and gait biomechanics. This study aims to determine whether PRP, ESWT, or the combination of both treatments provide superior functional recovery compared with exercise-based rehabilitation alone.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years
- •Diagnosis of unilateral midportion Achilles tendinopathy
- •Symptoms present for more than 3 months
- •VISA-A score <80 at baseline
- •Pre-injury physical activity level ≥3 on the Physical Activity Scale
- •Ability to participate in rehabilitation program
排除标准
- •Symptoms present for less than 3 months
- •Prior PRP injection or ESWT treatment to the Achilles tendon within 3 months
- •Other lower extremity musculoskeletal injury affecting function
- •Symptomatic arthritis affecting the ankle or foot
- •Rheumatologic disease or connective tissue disorder
- •Coagulopathy or anticoagulant therapy affecting platelet function
- •Neuropathy affecting pain perception
- •Known cardiac condition contraindicating treatment
- •Poorly controlled diabetes (HbA1c >9.0)
- •Pregnancy
研究组 & 干预措施
Arm 4 - Exercise Therapy + Platelet-Rich Plasma + Extracorporeal Shockwave Therapy
PRP will be administered followed by three sessions of ESWT. Standard of care exercise program will be prescribed to participants with four stages to be performed during the study.
干预措施: Platelet Rich Plasma (Device)
Arm 4 - Exercise Therapy + Platelet-Rich Plasma + Extracorporeal Shockwave Therapy
PRP will be administered followed by three sessions of ESWT. Standard of care exercise program will be prescribed to participants with four stages to be performed during the study.
干预措施: Extracorporeal Shockwave Therapy (Device)
Arm 1 - Control Exercise Therapy + Sham PRP + Sham Shockwave
A sham PRP injection will be performed where the needle breaks the skin but does not fenestrate the tendon. The sham ESWT will include radial pressure waves and focused shockwaves delivered without the device turned on to deliver energy and audio recording. Standard of care exercise program will be prescribed to participants with four stages to be performed during the study.
干预措施: Sham PRP (Device)
Arm 1 - Control Exercise Therapy + Sham PRP + Sham Shockwave
A sham PRP injection will be performed where the needle breaks the skin but does not fenestrate the tendon. The sham ESWT will include radial pressure waves and focused shockwaves delivered without the device turned on to deliver energy and audio recording. Standard of care exercise program will be prescribed to participants with four stages to be performed during the study.
干预措施: Sham ESWT (Device)
Arm 3 - Exercise Therapy + Extracorporeal Shockwave Therapy (ESWT) + Sham PRP
Sham PRP will be delivered. Three sessions of ESWT will be delivered to the Achilles tendon. Standard of care exercise program will be prescribed to participants with four stages to be performed during the study.
干预措施: Extracorporeal Shockwave Therapy (Device)
Arm 3 - Exercise Therapy + Extracorporeal Shockwave Therapy (ESWT) + Sham PRP
Sham PRP will be delivered. Three sessions of ESWT will be delivered to the Achilles tendon. Standard of care exercise program will be prescribed to participants with four stages to be performed during the study.
干预措施: Sham PRP (Device)
Arm 2 - Exercise Therapy + Platelet-Rich Plasma (PRP) + Sham Shockwave
PRP will be delivered around the tendon, sham ESWT will be issued. Standard of care exercise program will be prescribed to participants with four stages to be performed during the study.
干预措施: Platelet Rich Plasma (Device)
Arm 2 - Exercise Therapy + Platelet-Rich Plasma (PRP) + Sham Shockwave
PRP will be delivered around the tendon, sham ESWT will be issued. Standard of care exercise program will be prescribed to participants with four stages to be performed during the study.
干预措施: Sham ESWT (Device)
结局指标
主要结局
Victorian Institute of Sport Assessment-Achilles (VISA-A)
时间窗: baseline, 8 weeks, 4 months, 6 months
The VISA-A is an eight item questionnaire measures Achilles tendon pain and function, with scores ranging from 0 to 100 (higher scores indicating better function).
次要结局
- PROMIS-29 Patient Reported Outcomes(Baseline, 8 weeks, 4 months, 6 months)
- University of Wisconsin Running Injury and Recovery Index (UWRI)(baseline, 8 weeks, 4 months, 6 months)
- Ultrasound Tendon Cross-Sectional Area(baseline, 6 months)
- Heel Rise Test Endurance(baseline, 6 months)
- Hop Test Pain(baseline, 6 months)
- Gait Biomechanics(baseline, 6 months)
研究者
Adam Tenforde
Associate Professor, Harvard Medical School
Spaulding Rehabilitation Hospital