The Effects of Platelet Rich Plasma Versus Prolotherapy on Pain and Function in Rotator Cuff Tendinopathy: A Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pain Reduction change from baseline
研究概览
简要总结
Rotator cuff tendinopathy is the common cause of shoulder pain in the working-age group and the elderly (1). The condition reported takes an average of 10 months or longer to recover. Treatment ranges from non-surgical therapy through exercise, physiotherapy, injections to surgery (2). Injection of steroid was used in many cases to reduce pain. However, steroid only provided short term pain relief and did not resolve the main pathology. Emerging of biologics agents such as platelet-rich plasma (PRP) and prolotherapy are alternative to the treatment (3). PRP is a concentrated platelet which contains a high concentration of protein that helps in the healing process (4). Prolotherapy with the commonly used substance dextrose works by attracting inflammatory substrate and stimulate own body healing process (5).
This study takes place at the University of Malaya Medical Centre. Participants diagnosed with rotator cuff tendinopathy are randomly divided into two groups- Platelet Rich Plasma (PRP) group and Prolotherapy group. All participants are screened by the researcher for the eligibility to join the study. Subsequently, the participants undergo baseline assessment on the clinical, functional, biomechanics and ultrasound. Blood is taken in all patient, to make the patient blind to the intervention they received. In the PRP group- the participants received 2ml of PRP, and in prolotherapy group, the participants received 2ml of 16.5% dextrose solution. A single injection is done by an experienced Sports Physician using ultrasound-guided into the injured area. The assessor at baseline, and follow up are blinded to the intervention. The participants need to come for follow up at 3 weeks, 6 weeks, 3 months and 6 months after injection.
Systematic reviews showed the benefit of biologics agent to treat tendon injuries, especially for lateral epicondylitis and patellar tendinitis (6). Many studies for soft tissue injury were on PRP compared to prolotherapy. This study hypothesized that both treatments result in significant improvement in pain and function after the intervention. PRP might provide more significant improvement compared to prolotherapy.
详细描述
Study design This study is a randomized, double-blind, controlled trial conducted at the University of Malaya Medical Centre, Kuala Lumpur, Malaysia.
Patients The patients will be recruited from the following clinics: Sports Medicine, orthopaedic, rheumatology, outpatient and staff health. Notice of study invitation in this study will be distributed to all the respective clinic. Patients with a confirm diagnosis of supraspinatus tendinopathy by ultrasound or MRI will be invited to participate in this study. Study screening will be carried out to ensure the inclusion and exclusion criteria are fulfilled by the research team in Sports Medicine Clinic.
Procedures
PRP group Patients under PRP group will receive a single 2 mL injection of PRP into the injury site under ultrasound guidance administered by a sports physician. The PRP will be prepared using a commercial kit, Y-Cell BioKit Systems.
Prolotherapy group Patients in the prolotherapy group will receive a single 2 mL injection of 16.5% dextrose solution administered under ultrasound guidance.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chronic shoulder pain more than 3 months
- •Diagnosis of supraspinatus tendinopathy by Sports Physician or Orthopaedic
- •Diagnosis by ultrasound or MRI
排除标准
- •Patients with the following medical condition: autoimmune rheumatology disease, blood disorder
- •Patients with the following shoulder conditions: referred pain from cervical, recent shoulder surgery, shoulder instability, complete rotator cuff tear, adhesive capsulitis
- •Patients with the following medications: anti-coagulant treatment, steroid injection in less than 6 months
结局指标
主要结局
Pain Reduction change from baseline
时间窗: 3 weeks, 6 weeks, 3 months and 6 months
Visual analog score (VAS) score will be used. The scale is between 0 to 10; 0 is no pain, 10 is the worst pain imaginable
Functional score change from baseline
时间窗: 3 weeks, 6 weeks, 3 months and 6 months
Shoulder Pain and Disability Index (SPADI) questionnaire Two subscales namely pain and disability. Pain scale is from 0 to 10; 0 is no pain, 10 is the worst pain imaginable Disability scale range from 0 to 10; 0 no difficulty, 10 is so difficult it requires help
次要结局
- Peri-scapular Muscle activity(6 weeks, 3 months and 6 months)
- Strength in kg(3 weeks, 6 weeks, 3 months and 6 months)
- Range of Movement(3 weeks, 6 weeks, 3 months and 6 months)
- Ultrasound findings The parameters will be on tendon thickness, neo-vascularaization and tear size(6 weeks, 3 months and 6 months)
研究者
Dr. Samihah Abdul Karim
Dr
University of Malaya