Phase 2/Phase 3 of the Randomized Control Trial to Evaluate the Efficacy of Autologous Blood Injection Versus Local Corticosteroid Injection for Treatment of Lateral Epicondylitis.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain(at 4 Weeks): Visual Analogue Scale
研究概览
简要总结
Lateral epicondylitis, is a common problem encountered in the orthopaedic practice. Histopathological reports have shown that lateral epicondylitis is not an inflammatory process but a degenerative condition termed 'tendinosis'. Beneficial effects of local corticosteroid infiltration have sound lack of scientific rationale, since surgical specimens show lack of any inflammatory process. Recently an injection of "autologous blood injection" has been reported to be effective for both intermediate and long term outcomes. It is hypothesized that blood contains platelet derived growth factor induce fibroblastic mitosis and chemotactic polypeptides such as transforming growth factor cause fibroblasts to migrate and specialize and have been found to induce healing cascade. The objective of the study is to evaluate the efficacy of autologous blood injection versus local corticosteroid injection in the management of lateral epicondylitis.
详细描述
Much controversy has been there over the pathophysiology and there is not enough scientific evidence to favour any particular type of treatment for acute lateral epicondylitis. Currently degeneration of the origin of the extensor carpi radialis brevis (ECRB), repeated micro trauma and incomplete healing response has been accepted as the cause of lateral epicondylitis by most of the researchers.
Histopathological reports have shown that lateral epicondylitis is not an inflammatory process but a degenerative condition termed 'tendinosis'. There are numerous treatment modalities for lateral epicondylitis both conservative and operative. Most conservative modalities such as local corticosteroid injection have focused on suppressing inflammatory process that does not actually exist. A recent review article concluded that for short term outcomes (6 weeks), statistically significant and clinically relevant differences were found on pain and global improvement with corticosteroid injection compared to placebo, local anaesthetic, or other conservative treatments. For intermediate (6 weeks to 6 months) and long term outcomes (more than 6 months), no statistically significant or clinically relevant results in favour of corticosteroid injections were found. So it is not possible to draw a firm conclusion on the effectiveness of corticosteroid injection.
Recently an injection of autologous blood has been reported to be effective for both intermediate and long term outcomes for the treatment of lateral epicondylitis. There was a significant decrease in pain. It is hypothesized that mitogens such as platelet derived growth factor induce fibroblastic mitosis and chemotactic polypeptides such as transforming growth factor cause fibroblasts to migrate and specialize and have been found to cause angiogenesis. A specific humoral mediator may promote the healing cascade in the treatment of tendinosis as well. These growth factors trigger stem cell recruitment, increase local vascularity and directly stimulate the production of collagen by tendon sheath fibroblasts.
Autologous blood was selected as the medium for injection because (1) its application is minimally traumatic, (2) it has a reduced risk for immune-mediated rejection, devoid of potential complications such as hypoglycemia, skin atrophy, tendon tears associated with corticosteroid injection (3) it is simple to acquire and prepare, easy to carry out as outpatient procedure and (4) it is inexpensive.
There are very few studies done to evaluate injection of autologous blood for lateral epicondylitis as treatment modality. Hence it is evaluated by comparing with the corticosteroid injection which is a commonly practiced conservative treatment modality.
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
- None
入排标准
- 年龄范围
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cases of lateral epicondylitis.
- •Men and women above fifteen years of age.
排除标准
- •Patients receiving steroid injections within three months before blood injection.
- •A history of substantial trauma.
- •Previously treated by surgery for lateral epicondylitis.
- •Other causes of elbow pain such as osteochondritis dessecans of capitellum, lateral compartment arthrosis, varus instability, radial head arthritis, posterior interosseous nerve syndrome, cervical disc syndrome, synovitis of radiohumeral joint, cervical radiculopathy, fibromyalgia, osteoarthritis of elbow, carpel tunnel syndrome.
研究组 & 干预措施
Autologous blood injection group
This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
干预措施: Autologous blood injection (Biological)
Local corticosteroid injection group
This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
干预措施: Local corticosteroid injection (Drug)
结局指标
主要结局
Pain(at 4 Weeks): Visual Analogue Scale
时间窗: 4 weeks
VISUAL ANALOGUE SCALE: Pain of the participants will be assessed by most widely used and accepted "visual analogue scale". It consists of a 10 centimeter line marked at one end with "no pain" and at other end with "worst pain ever". Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between "no pain" to patients mark. No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever.
Pain(at 12 Weeks): Nirschl Staging
时间窗: 12 weeks
NIRSCHL STAGING: phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain
Pain(at 1 Week): Nirschl Staging (0 to 7)
时间窗: 1 week
NIRSCHL STAGING: phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain
Pain (at 1 Week): Visual Analogue Scale(0 to 10)
时间窗: 1 week
VISUAL ANALOGUE SCALE: Pain of the participants will be assessed by most widely used and accepted "visual analogue scale". It consists of a 10 centimeter line marked at one end with "no pain" and at other end with "worst pain ever". Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between "no pain" to patients mark. No pain____1___2___3___4___5___6___7___8___9___10 worst pain ever.
Pain(at 12 Weeks): Visual Analogue Scale
时间窗: 12 weeks
VISUAL ANALOGUE SCALE: Pain of the participants will be assessed by most widely used and accepted "visual analogue scale". It consists of a 10 centimeter line marked at one end with "no pain" and at other end with "worst pain ever". Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between "no pain" to patients mark. No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever.
Pain(at 6 Months): Visual Analogue Scale
时间窗: 6 months
VISUAL ANALOGUE SCALE: Pain of the participants will be assessed by most widely used and accepted "visual analogue scale". It consists of a 10 centimeter line marked at one end with "no pain" and at other end with "worst pain ever". Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between "no pain" to patients mark. No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever.
Pain(at 4 Weeks): Nirschl Staging
时间窗: 4 weeks
NIRSCHL STAGING: phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain
Pain(at 6 Months): Nirschl Staging
时间窗: 6 months
NIRSCHL STAGING: phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain
次要结局
未报告次要终点