Does Combined Polydeoxyribonucleotide Improve the Outcome of Extensor Muscle Strengthening Exercise with Extracorporeal Shockwave Therapy for Lateral Epicondylitis of Elbow?: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Pain Reduction
研究概览
简要总结
The goal of this clinical trial is to investigate the synergistic effect of polydeoxyribonucleotide (PDRN) on extensor muscle strengthening exercise (EMSE) combined with extracorporeal shockwave therapy (ESWT) for treating lateral epicondylitis (LE) of the elbow in adults aged 18 to 65 years. The main questions it aims to answer are:
Does the addition of PDRN improve pain reduction as measured by the Visual Analog Scale (VAS)? Does the addition of PDRN enhance functional outcomes such as the Mayo Elbow Performance Score (MEPS) and Hand Grip Strength Index (HGSI)?
Researchers will compare two groups to see if PDRN provides additional benefits:
Group 1: EMSE + ESWT + saline injection Group 2: EMSE + ESWT + PDRN injection
Participants will:
Perform extensor muscle strengthening exercises Receive extracorporeal shockwave therapy Receive either a saline injection or a PDRN injection at the first outpatient department visit Attend follow-up visits at 6 and 12 weeks for assessments
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 65 years Diagnosed with chronic lateral epicondylitis (LE) of the elbow Willing to perform extensor muscle strengthening exercises Able to attend follow-up visits at 6 and 12 weeks
排除标准
- •History of elbow surgery Significant trauma to the elbow Current use of corticosteroids for LE Current use of other treatments for LE Pregnant or breastfeeding women Participation in another clinical trial within the last 30 days
研究组 & 干预措施
Group 2 (G2): EMSE + ESWT + PDRN Injection
Participants in this group will perform extensor muscle strengthening exercises and receive extracorporeal shockwave therapy. Additionally, they will receive a 3mL injection of polydeoxyribonucleotide (PDRN) at the first outpatient department visit.
干预措施: Extensor Muscle Strengthening Exercise (Behavioral)
Group 1 (G1): EMSE + ESWT + Saline Injection
Participants in this group will perform extensor muscle strengthening exercises and receive extracorporeal shockwave therapy. Additionally, they will receive a 3mL saline injection at the first outpatient department visit.
干预措施: Extensor Muscle Strengthening Exercise (Behavioral)
Group 1 (G1): EMSE + ESWT + Saline Injection
Participants in this group will perform extensor muscle strengthening exercises and receive extracorporeal shockwave therapy. Additionally, they will receive a 3mL saline injection at the first outpatient department visit.
干预措施: Extracorporeal Shockwave Therapy (Procedure)
Group 1 (G1): EMSE + ESWT + Saline Injection
Participants in this group will perform extensor muscle strengthening exercises and receive extracorporeal shockwave therapy. Additionally, they will receive a 3mL saline injection at the first outpatient department visit.
干预措施: Saline injection (Octreotide LAR placebo) (Drug)
Group 2 (G2): EMSE + ESWT + PDRN Injection
Participants in this group will perform extensor muscle strengthening exercises and receive extracorporeal shockwave therapy. Additionally, they will receive a 3mL injection of polydeoxyribonucleotide (PDRN) at the first outpatient department visit.
干预措施: Extracorporeal Shockwave Therapy (Procedure)
Group 2 (G2): EMSE + ESWT + PDRN Injection
Participants in this group will perform extensor muscle strengthening exercises and receive extracorporeal shockwave therapy. Additionally, they will receive a 3mL injection of polydeoxyribonucleotide (PDRN) at the first outpatient department visit.
干预措施: Polydeoxyribonucleotide Injection (Drug)
结局指标
主要结局
Pain Reduction
时间窗: Baseline, 6 weeks, 12 weeks
Pain Reduction as measured by the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain), with higher scores indicating worse pain.
次要结局
- Functional Improvement(Baseline, 6 weeks, 12 weeks)
- Grip Strength Improvement(Baseline, 6 weeks, 12 weeks)
- Common Extensor Tendon Depth Measured by Ultrasonography(Baseline, 6 weeks, 12 weeks)
- Color Doppler Activity Measured by Ultrasonography(Baseline, 6 weeks, 12 weeks)
研究者
Jung-Taek Hwang
Professor
Chuncheon Sacred Heart Hospital