Treatment of Post Traumatic Knee Osteoarthritis With Extracorporeal Shockwave Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Knee Injury and Osteoarthritis Outcome Score (KOOS)
研究概览
简要总结
This study is recruiting current or former athletes who had ACL reconstruction surgery over a year ago and have been diagnosed with knee osteoarthritis (OA). We are doing the research to investigate the effects of extracorporeal shockwave therapy (ESWT) on pain, function, biomechanics, knee range of motion and strength, inflammation, and joint structure and integrity of the knee.
详细描述
The goal of this study is to characterize redox homeostasis in post-traumatic osteoarthritis (PTOA), with the goal of examining the impact of extracorporeal shockwave therapy (ESWT). We will explore the following aims:
Specific Aim 1: Investigate the effects of ESWT treatment on participant-reported functional outcomes and quality of life in individuals with PTOA of the knee. We hypothesize that those in ESWT group will report greater improvements in pain level, function and quality of life compared to those individuals in the sham group.
Specific Aim 2: Determine if ESWT influences gait biomechanics of participants with PTOA. We hypothesize that those in ESWT group will display biomechanics during gait that more closely resemble the biomechanics of a healthy individual. We anticipate that this aim will identify if a more favorable inflammation burden will reduce abnormal biomechanics, or if further interventions will be necessary.
Specific Aim 3: Investigate the influence of ESWT on joint conductivity and inflammation of the knee using bioimpedance spectroscopy (BIS). This has yet to be explored in the PTOA population and thus our objective is to explore knee-site tissue changes in PTOA following ESWT. Thermal pattern has been used to identify active inflammation in the osteoarthritic knee with respect to a healthy knee. We hypothesize that there will be improvements in tissue changes and thermal pattern in the knee measured by BIS and thermal camera following ESWT.
Specific Aim 4: Evaluate baseline values of knee range of motion, lower extremity strength, and bone health and determine if ESWT may influence these measures. We will collect measures of knee range of motion, quadriceps isometric strength and rate of torque development with handheld dynamometry, and measurements of bone density with DXA scans. We hypothesize that knee range of motion, quadriceps strength and rate of torque development will yield greater improvements following ESWT compared to sham treatment.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous ACL reconstruction using an autograft or allograft in the knee with PTOA
- •Minimum of one year following ACL reconstruction surgery
- •Between ages of 18 and 55
- •No clear contraindication to complete protocol including mechanical symptoms which would limit ability to complete the study
- •Score on KOOS for 2 of 4 domains (pain, symptoms, activities of daily living (ADL), quality of life (QOL)) of 85 or lower
- •Primary pain is coming from the knee
- •Diagnosis of PTOA based on clinical diagnosis and confirmation with radiographic evidence by a medical professional prior to study enrollment. If individuals have suspected OA based on impairments such as pain, they must have a score on KOOS for 2 of 4 domains (pain, symptoms, activities of daily living (ADL), quality of life (QOL)) of 85 or lower to participate in the study.
排除标准
- •Have previously received injections to the knee joint within the past 3 months
- •Women who are pregnant or those who are planning to become pregnant. This is due to the fact that pregnancy will reduce participants activity after the treatment and the safety concerns related to shockwave treatment. - Participants with neuropathy affecting sensation to pain
- •Participants with a known underlying cardiac disease that could be affected by shockwave therapy
- •Chronic rheumatological conditions, immunodeficiency, severe asthma, connective tissue disorder (i.e. Ehlers-Danlos Syndrome), or other medical conditions (ex. active malignancy, severe asthma) outside of PTOA that are known to impact inflammatory state or requiring chronic use of oral or intravenous immune modulatory medications. Asthma requiring use of inhalers only is not an exclusion criteria
- •Neuropathy diagnosis that can affect response to pain
- •No active use of oral steroids or anti-inflammatories at the time of enrollment
- •Have bilateral ACL injury or reconstruction surgery, or have had ACL revision surgery
- •No active malignancy and at least five years in remission
- •Previous ESWT treatment using study treatment devices for management of knee osteoarthritis
- •Have a pacemaker, bone screws, or any other metal implants that would prohibit participation in an MRI scan or EWST
- •Non-English speaking individuals
结局指标
主要结局
Knee Injury and Osteoarthritis Outcome Score (KOOS)
时间窗: From baseline to 4-month follow up with intermediate measure at 8 weeks
The KOOS is is a 42-item survey with 5 subscales designed to measure patient health, symptoms, and functionality of the knee. It is scored from 0-100, with higher score correlated with better function.
次要结局
- Biomarkers of oxidative stress and inflammation(Baseline, at each of the three treatment sessions and at 4 months)
- Biomechanics(Baseline and 4 months)
- Knee range of motion(Baseline and 4 months)
- Quadriceps strength and power(Baseline and 4 months)
- Quantitative Sensory Testing (Pain Pressure Threshold)(Baseline and 4 months)
- Non-contrast MRI(Baseline and 4 months)
- Thermal Imaging(Baseline and 4 months)
- Bioimpedance(Baseline and 4 months)
- Knee X-rays(Baseline)
- Bone Mineral Density Scan by DEXA(Baseline)
- Height in meters(Baseline)
- Leg length in meters(Baseline)
- Weight in kg(Baseline)
- Patient-Reported Outcomes Measurement Information System (PROMIS-29)(From baseline to 4-month follow up with intermediate measure at 8 weeks)
- Single Assessment Numeric Evaluation (SANE)(From baseline to 4-month follow up with intermediate measure at 8 weeks)
- Patient Acceptable Symptom State (PASS)(From baseline to 4-month follow up with intermediate measure at 8 weeks)
- Visual Analog Scale (VAS)(From baseline to 4-month follow up with intermediate measure at 8 weeks)
- PainDETECT(From baseline to 4-month follow up with intermediate measure at 8 weeks)
- Lateral Preference Inventory (LPI)(Baseline)
研究者
Adam Tenforde
Physician
Spaulding Rehabilitation Hospital