The Clinical Application of PLT Combined With Steroid in Lateral Epicondylopathy and Supraspinatus Calcific Tendinopathy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Lateral elbow pain and shoulder pain (worst in the last one week)
研究概览
简要总结
PLT vs. steroid vs. PLT + steroid, which treatment is most effective in lateral epicondylitis (or tennis elbow) and supraspinatus calcific tendinitis.
详细描述
Lateral epicondylitis (or tennis elbow) and supraspinatus calcific tendinitis are common tendinopathies of the upper limb and both have negative impacts on the patients' quality of life. The former affects function of wrist extension due to degeneration of common extensor tendons; the latter causes severe pain and limitation of shoulder range of motion due to calcific deposits within the supraspinatus tendon. Current common injection therapies are ultrasound-guided injection of steroid or platelet-rich plasma (PRP).
Previous studies have shown that steroid injection provides early but short-term pain reduction, while PRP injection causes post-injection pain by inducing inflammation but provides long-term pain relief and functional improvement. It may provide early pain reduction with long-term tissue regeneration if combining steroid and PRP. A recent study on tennis elbow showed that inclusion of steroid in the autologous whole blood and 20% dextrose injection can reduce pain during early treatment, without interfering with the therapeutic effects.
Furthermore, disadvantages of current PRP include difficulty in quantifying platelet numbers and growth factor activity, and in long-term preservation. In this study lyophilized platelet (PLT) can solve these problems, which can be dissolved in saline before injection.
This 3-arm randomized controlled trial will divide subjects into the PLT group (group A), steroid group (group B) or PLT+steroid group (group C). Therapeutic effects will be evaluated by pain visual analogue scale (VAS), grip dynamometer, and disabilities of the arm, shoulder, and hand (DASH) questionnaires during follow-ups at 2nd, 4th, 6th, 12th and 24th week after treatment, and ultrasound at 12th and 24th week . The hypothesis is that PLT+steroid injection will have earlier pain reduction than PLT injection and longer effects of pain reduction and functional improvement.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The syringe is covered.
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tenderness at lateral epicondyle more than 3 months
- •Ultrasound-confirmed lateral epicondylopathy
- •Pain VAS ≥ 3/10 during wrist resistive extension
- •No treatment response to NSAID and physiotherapy
排除标准
- •Pregnancy or lactation
- •Carpal tunnel syndrome (the same arm) in one year
- •Cervical radiculopathy
- •Taking NSAID in one week
- •Receiving PRP or steroid injection in one month
- •History of bacteremia, cellulitis or skin ulcer in three months
- •Rheumatoid arthritis
- •Malignancy
- •Poorly controlled diabetets mellitus (DM), liver and kidner diseases
- •Severe anemia (Hb<5)
- •Thrombocytopenia
- •History of tennis elbow surgery
- •History of elbow trauma
- •Supraspinatus calcific tendinis
- •Inclusion Criteria:
- •Hawkins-Kennedy test or empty can test, one of which is positive
- •Ultrasound-confirmed (calcification > 2mm)
- •Pain VAS ≥ 3/10 over right deltoid area more than 3 months
- •No treatment response to NSAID and physiotherapy
- •Exclusion Criteria:
- •Pregnancy or lactation
- •Carpal tunnel syndrome (the same arm) in one year
- •Cervical radiculopathy
- •Taking NSAID in one week
- •Receiving PRP or steroid injection in one month
- •History of bacteremia, cellulitis or skin ulcer in three months
- •Rheumatoid arthritis
- •Malignancy
- •Poorly controlled DM, liver and kidner diseases
- •Severe anemia (Hb<5)
- •Thrombocytopenia
- •History of shoulder surgery
- •History of shoulder trauma
研究组 & 干预措施
PLT (lyophilized platelet) with steroid
PLT (30ng)+1.0 mL 1.0% Lidocaine+1.0 mL (10.0 mg/mL) Triamcinolone acetonide, once
干预措施: lyophilized platelet (30ng) and triamcinolone acetonide 10mg (Combination Product)
PLT (lyophilized platelet)
PLT (30ng)+1.0 mL 1.0% Lidocaine+1.0 mL normal saline, once
干预措施: lyophilized platelet (30ng) (Other)
Steroid
1.0 mL 1.0% Lidocaine+1.0 mL (10.0 mg/mL) Triamcinolone acetonide, once
干预措施: triamcinolone acetonide 10mg (Drug)
结局指标
主要结局
Lateral elbow pain and shoulder pain (worst in the last one week)
时间窗: 24 weeks post-injection
Visual analogue scale (0-10, the high the worse)
次要结局
- Lateral elbow pain and shoulder pain (worst in the last one week)(Baseline, 2, 4, 6, and 12 weeks post-injection)
- Functional(Baseline, 2, 4, 6, 12, and 24 weeks post-injection)
- Grasping power(Baseline, 2, 4, 6, 12, and 24 weeks post-injection)
- Ultrasound(Baseline, 12 and 24 weeks post-injection)