The Comparison and Combination of Semiconductor Embedded Therapeutic Arm Sleeves and Platelet-Rich Plasma With Adipose Stem Cell (PRP+ASC) Injections for the Treatment of ECRB Tendinopathy (Lateral Epicondylitis): A Randomized, Double-Blinded, Placebo-Controlled Prospective Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change in patient elbow function and pain as determined by the Patient-Rated Tennis Elbow Evaluation (PRTEE).
研究概览
简要总结
This study seeks to identify patient reported and clinically measured outcomes for pain management and elbow function with application of semiconductor embedded fabric combined with PRP+ASC injections in the affected area.
详细描述
Extensor Carpi Radialis Brevis (ECRB) tendinopathy, also known as lateral epicondylitis or tennis elbow, is the most prevalent elbow soft tissue injury and affects 1-3% of the population. Repetitive overloading of the tendon and ligaments in the elbow lead to microtraumas, causing abnormal angiofibroblastic remodeling and increased pain. Microtearing occurs most commonly at the origin of the extensor carpi radialis brevis (ECRB) tendon. The main symptoms include a loss of grip strength, a burning sensation near the ECRB origin site, and pain during daily activities such as grasping objects or shaking hands. Both conditions present a significant injury and treatment burden on the population and effective treatment and pain management approaches with minimal side effects are needed.
Novel nonsurgical treatment approaches for ECRB tendinopathy include platelet-rich plasma (PRP) injections and stem cell therapy. Ultrasound-guided PRP and adipose-derived stem cells (ASCs) injections have shown to be an effective treatment option for patients with chronic ECRB tendinopathy.
The proposed study seeks to assess the effect of non-compressive semiconductor embedded arm sleeves in combination with PRP + ASC injections, throughout a 6-month rehabilitation course for patients with ECRB tendinopathy. Outcome measures will be collected at standardized intervals to evaluate and compare treatment groups.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with ECRB tendinopathy as determined by radiographic assessment or ultrasound imaging.
- •Patients age 18-65
- •Patients who are willing and able to adhere to follow-up schedule and protocol guidelines.
- •Patients who are willing and able to sign corresponding research subject consent form.
排除标准
- •Patient has a history of neurological conditions, including multiple sclerosis or Parkinson's disease
- •Patient has severe medical condition, including recent myocardial infarction, unstable angina, heart failure, severe anemia
- •Patient has had prior surgical treatment of the elbow in the last 5 years or injection treatment(s) in the last 2 years
- •Patient has complete tear of ECRB tendon or other surgical indication
- •Patient has chronic pain conditions unrelated to elbow condition
- •Patient has auto-immune or auto-inflammatory diseases
- •Patient has used tobacco within the last 90 days
- •Patient is not within the ages of 18-65
- •Patient has a history of metabolic disorders
- •Patient has an active infection (local or systemic)
- •Patient is unwilling or unable to sign the corresponding research subject consent form
- •Patient meets any other criteria or has any other condition that, in the opinion of the investigator, would prevent them from completing the study or that, in the opinion of the investigator, would confound study results.
研究组 & 干预措施
Incrediwear only
One group will receive active therapy (semiconductor embedded arm sleeve) "Incrediwear only"
干预措施: Semiconductor Embedded Therapeutic Arm Sleeves (Device)
Sham Incrediwear
One group will receive placebo therapy (arm sleeve absent of semiconductor thread) "Sham Incrediwear"
干预措施: Placebo Arm Sleeves (Device)
Incrediwear with PRP+ASC injections
One group will receive active therapy with SOC (standard of care) PRP+ASC injections (active semiconductor embedded arm sleeves after they have received PRP+ ASC injections as part of their routine care) "Incrediwear with SOC PRP+ASC injections"
干预措施: Semiconductor Embedded Therapeutic Arm Sleeves (Device)
Incrediwear with PRP+ASC injections
One group will receive active therapy with SOC (standard of care) PRP+ASC injections (active semiconductor embedded arm sleeves after they have received PRP+ ASC injections as part of their routine care) "Incrediwear with SOC PRP+ASC injections"
干预措施: Platelet-Rich Plasma with Adipose Stem Cell (PRP+ASC) Injections (Other)
Sham Incrediwear with PRP+ASC injections
One group will receive placebo therapy with SOC (standard of care) PRP+ASC injections (arm sleeve absent of semiconductor fabric after they have received PRP+ASC injections as part of their routine care) "Sham Incrediwear with SOC PRP+ASC injections"
干预措施: Placebo Arm Sleeves (Device)
Sham Incrediwear with PRP+ASC injections
One group will receive placebo therapy with SOC (standard of care) PRP+ASC injections (arm sleeve absent of semiconductor fabric after they have received PRP+ASC injections as part of their routine care) "Sham Incrediwear with SOC PRP+ASC injections"
干预措施: Platelet-Rich Plasma with Adipose Stem Cell (PRP+ASC) Injections (Other)
结局指标
主要结局
Change in patient elbow function and pain as determined by the Patient-Rated Tennis Elbow Evaluation (PRTEE).
时间窗: 6 months
The Patient-Rated Tennis Elbow Evaluation (PRTEE) is a self-administered questionnaire that assesses elbow pain and functional ability in patients with tennis elbow. The minimum number is zero meaning no pain and the maximum number is 10 meaning the worst imaginable pain. Lower scores are ideal while higher scores are indicative of the patient in a lot of pain and minimal functional ability
次要结局
- Change in pain as determined by the Visual Analog Scale (VAS).(6 months)
- Change in patient elbow function as determined by the Disabilities of the Arm, Shoulder, and Hand (DASH).(6 months)
- Change in grip strength as measured by a hand dynamometer(6 months)