Prospective Randomize Trial Comparing Corticosteroid Injection to High Energy Extracorporeal Shock Wave Therapy for Lateral Epicondylitis
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Disabilities of the Arm, Shoulder and Hand (DASH)
研究概览
简要总结
The purpose of this study is to prospectively compare the pain and functional outcomes of patients with chronic lateral epicondylitis treated with either intratendinous corticosteroid injection or high energy extracorporeal shock wave therapy (ESWT).
详细描述
Corticosteroid injections and high energy ESWT are standard therapies for lateral epicondylitis at Walter Reed National Military Medical Center. While corticosteroid injections have been shown to be moderately effective in the short term for the condition, a significant minority of patients remains symptomatic. Low energy ESWT has mixed results in the orthopaedic literature, but to date no study has specifically examined the effects of high energy ESWT. The investigators plan to randomize a total of 80 patients with the diagnosis of lateral epicondylitis to either corticosteroid injection or high energy ESWT, and follow them for a total of 12 months. Primary outcomes will be Disabilities of the Arm, Shoulder, and Hand (DASH) score, Patient Reported Tennis Elbow Evaluation (PRTEE) score, Mayo Elbow Score, Veterans Rand-36, and return-to-work status. Patients will be surveyed at baseline, 6 weeks, 3 months, and 6 months. All assessments will be done by an independent physician examiner who is blinded to the treatment received.
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
- Single (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
- •All patients presenting to the WRNMMC orthopaedic hand surgery clinic for complaints of lateral elbow pain will be evaluated for inclusion in the study. Inclusions criteria will be:
- •Clinical diagnosis of lateral epicondylitis based on primary complaint of lateral elbow pain and either (a) tenderness over the lateral epicondyle with direct palpation, or (b) exacerbation of pain at the lateral elbow with resisted dorsiflexion of the wrist
- •Failure of previous trial of non-operative management of at least 4wks duration (to include rest/light duty, non steroidal anti-inflammatory drugs , physical/occupational therapy, home stretching regimen)
排除标准
- •Age <18yo
- •Pregnant or planning to become pregnant during study period (based on verbal questioning)
- •Steroid treatment (oral or injectable) within the previous 3mo
- •Diagnosis of ipsilateral compressive neuropathy
- •Allergy to Kenalog, lidocaine, or conductive ultrasound gel
- •Diagnosis of inflammatory arthropathy or rheumatoid conditions
- •Diagnosis of fibromyalgia, chronic fatigue syndrome, complex regional pain syndrome, or other chronic widespread pain syndromes
研究组 & 干预措施
Kenalog (triamcinolone )
Patients assigned to the corticosteroid arm will receive an intratendinous injection of 1cc Kenalog-40 (triamcinolone-40mg) + 2cc lidocaine 1% by an attending orthopaedic hand surgeon in clinic. They will be provided a home stretching regimen for lateral epicondylitis. They will be discouraged from using nonsteroidal anti-inflammatory drugs . No additional physical or occupational therapy will prescribed.
干预措施: Kenalog (triamcinolone) (Drug)
Kenalog (triamcinolone )
Patients assigned to the corticosteroid arm will receive an intratendinous injection of 1cc Kenalog-40 (triamcinolone-40mg) + 2cc lidocaine 1% by an attending orthopaedic hand surgeon in clinic. They will be provided a home stretching regimen for lateral epicondylitis. They will be discouraged from using nonsteroidal anti-inflammatory drugs . No additional physical or occupational therapy will prescribed.
干预措施: lidocaine 1% (lidocaine HCl 20mg) (Drug)
extracorporeal shock wave therapy
Following clearance, patients will be booked for ESWT in the operating room either Walter Reed National Military Medical Center (WRNMMC) or Kimbrough Ambulatory Care Center (KACC), depending on availability. Under conscious sedation, patients will receive 2000 shocks at 18-24 kilovolts, which is the standard dose utilized by our clinic in treatment of this condition. The range is necessary to account for differing size of the soft tissue envelope depending on patient habitus. The final dose utilized will be at the surgeon's discretion.
干预措施: extracorporeal shock wave therapy (Procedure)
结局指标
主要结局
Disabilities of the Arm, Shoulder and Hand (DASH)
时间窗: 6 months
DASH is a questionnaire to measure upper extremity symptoms and ability to perform activities. Difference between the Kenalog (triamcinolone ) group and extracorporeal shock wave therapy at six months following intervention.
Mayo Elbow Score
时间窗: 6 months
Mayo Elbow score is an elbow focused outcome score. Difference between the Kenalog (triamcinolone ) group and extracorporeal shock wave therapy at six months following intervention.
Patient-Related Tennis Elbow Evaluation (PRTEE)
时间窗: 6 months
PRTEE is a questionnaire to measure pain and disability in patients with lateral epicondylitis. Difference between the Kenalog (triamcinolone ) group and extracorporeal shock wave therapy at six months following intervention.
Visual Analog Scale (VAS)
时间窗: 6 months
VAS is a measurement instrument to quantify pain. Difference between the Kenalog (triamcinolone ) group and extracorporeal shock wave therapy at six months following intervention.
Veteran Rand 36 Item Health Survey (VR-36)
时间窗: 6 months
VR-36 is a 36 item health survey widely used in the veteran population. Difference between the Kenalog (triamcinolone ) group and extracorporeal shock wave therapy at six months following intervention.
次要结局
- Grip Strength(6 months)