Ultrasound-Guided Dry Needling Versus Extracorporeal Shock Wave Therapy in Lateral Epicondylitis: A Randomized Single-Blind Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in pain intensity measured by Visual Analog Scale (VAS)
研究概览
简要总结
This randomized single-blind controlled trial aims to compare the effectiveness of ultrasound-guided dry needling and extracorporeal shock wave therapy in patients with lateral epicondylitis. Sixty participants aged 18-65 years will be randomized into two groups. The dry needling group will receive ultrasound-guided tendon fenestration once weekly for five sessions, while the ESWT group will receive radial extracorporeal shock wave therapy once weekly for five sessions. All participants will be given a standardized home exercise program. Pain, function, grip strength, pressure pain threshold, quality of life, and ultrasonographic findings will be evaluated at baseline, post-treatment, and at 3- and 6-month follow-up. The primary outcome is change in pain severity measured by Visual Analog Scale.
详细描述
This prospective, randomized, parallel-group, single-blind clinical trial is designed to compare the effectiveness of ultrasound-guided dry needling and extracorporeal shock wave therapy in patients with lateral epicondylitis. Participants aged 18-65 years with symptoms lasting at least six weeks will be randomly assigned in a 1:1 ratio using computer-generated block randomization with sealed opaque envelopes. Due to the nature of the interventions, participants and treating physicians will not be blinded; however, all clinical and ultrasonographic assessments will be performed by an investigator blinded to treatment allocation.
Participants in the dry needling group will receive ultrasound-guided tendon fenestration targeting the pathologic area of the common extensor tendon. The procedure will be performed once weekly for five sessions. Participants in the ESWT group will receive radial extracorporeal shock wave therapy applied to the most tender point over the lateral epicondyle using standard treatment parameters. ESWT will also be administered once weekly for five sessions.
All participants will receive a standardized home exercise program consisting of eccentric strengthening and stretching exercises for the wrist extensors. Assessments will be performed at baseline, immediately after treatment, and at 3- and 6-month follow-up visits. Outcome measures will include pain intensity, functional status, grip strength, pressure pain threshold, quality of life, and ultrasonographic tendon characteristics including grayscale and Power Doppler findings.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Outcome assessments, ultrasonographic evaluations, and statistical analyses will be performed by investigators blinded to treatment allocation.
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
- •Clinical diagnosis of lateral epicondylitis
- •Symptoms persisting for at least 6 weeks
- •Pain over the lateral epicondyle aggravated by wrist extension or gripping activities
- •Positive provocative tests consistent with lateral epicondylitis (e.g., Cozen's test and/or Mill's test)
- •Ability to understand the study procedures and provide written informed consent
排除标准
- •Previous surgery for lateral epicondylitis in the affected elbow
- •Corticosteroid injection, PRP injection, prolotherapy, mesotherapy, or ESWT to the affected elbow within the previous 6 months
- •Bilateral lateral epicondylitis requiring simultaneous treatment
- •Cervical radiculopathy or other neurologic disorders affecting the upper extremity
- •Inflammatory rheumatic disease
- •Elbow osteoarthritis or significant structural elbow pathology
- •Full-thickness tendon tear or other major tendon injury on imaging
- •Pregnancy or breastfeeding
- •Active infection, skin lesion, or wound at the treatment site
- •Use of anticoagulant therapy or bleeding disorder
- •Inability to comply with follow-up assessments
研究组 & 干预措施
Extracorporeal Shock Wave Therapy
Participants will receive radial extracorporeal shock wave therapy applied to the lateral epicondyle once weekly for five sessions. All participants will also perform a standardized home exercise program.
干预措施: Extracorporeal Shock Wave Therapy (Device)
Ultrasound-Guided Dry Needling
Participants will receive ultrasound-guided dry needling applied to the common extensor tendon once weekly for five sessions. All participants will also perform a standardized home exercise program.
干预措施: Ultrasound-guided dry needling (Procedure)
结局指标
主要结局
Change in pain intensity measured by Visual Analog Scale (VAS)
时间窗: Baseline (Week 0), end of treatment after 5 weekly sessions (Week 5), 12 weeks post-treatment (Week 17), and 24 weeks post-treatment (Week 29).
Pain intensity will be assessed using a 10-cm visual analog scale. Change from baseline to immediate post-treatment, upto 3 months, and upto 6 months will be analyzed. The Visual Analogue Scale (VAS) was used to assess the severity of elbow pain during activity. Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain severity and therefore a worse outcome.
次要结局
- Change in grip strength(Baseline (Week 0), end of treatment after 5 weekly sessions (Week 5), 12 weeks post-treatment (Week 17), and 24 weeks post-treatment (Week 29).)
- Change in pressure pain threshold(Baseline (Week 0), end of treatment after 5 weekly sessions (Week 5), 12 weeks post-treatment (Week 17), and 24 weeks post-treatment (Week 29).)
- Change in ultrasonographic tendon thickness(Baseline (Week 0), end of treatment after 5 weekly sessions (Week 5), 12 weeks post-treatment (Week 17), and 24 weeks post-treatment (Week 29).)
- Change in Patient-Rated Tennis Elbow Evaluation (PRTEE) score(Baseline (Week 0), end of treatment after 5 weekly sessions (Week 5), 12 weeks post-treatment (Week 17), and 24 weeks post-treatment (Week 29).)
- Change in quality of life measured by SF-12(Baseline (Week 0), end of treatment after 5 weekly sessions (Week 5), 12 weeks post-treatment (Week 17), and 24 weeks post-treatment (Week 29).)
- Change in Power Doppler neovascularization score(Baseline (Week 0), end of treatment after 5 weekly sessions (Week 5), 12 weeks post-treatment (Week 17), and 24 weeks post-treatment (Week 29).)
研究者
Berna Gunay, MD
Specialist in Physical Medicine and Rehabilitation
Haydarpasa Numune Training and Research Hospital