Ultrasound-guided Tendon Fenestration Versus Open Surgery for the Treatment of Chronic Lateral Epicondylosis of the Elbow: a Prospective, Randomized, Single Blind, Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Patient Rated Tennis Elbow Evaluation
研究概览
简要总结
Lateral epicondylosis, also called tennis elbow or lateral epicondylitis, is a prevalent, painful syndrome of the elbow. It is refractory to conservative treatment measures, including rest, excentric and concentric exercises in approximately 20% of patients after 6 months. Corticosteroid injections can provide relief in the short term. Mini-open surgery may be proposed when the conservative treatment fails and studies have shown an efficacy of 70%. Ultrasound-guided tendon fenestration is a minimally-invasive technique which stimulates the physiological healing mechanisms of the tendon and appears promising for the treatment of chronic tendinopathies. To our knowledge, no studies have compared the US-guided fenestration technique to mini-open surgery for the treatment of chronic lateral epicondylosis.
The primary objective of this pilot study is to compare the efficacy of US-guided fenestration to mini-open surgery to reduce pain and improve functional status in workers suffering from chronic lateral epicondylosis refractory to 6-month conservative treatment.
This is a prospective single-blind randomized pilot study. Sixty-four subjects will be randomized into two intervention groups for treatment either by US-guided fenestration or mini-open surgery. The primary outcome of the study will be the Patient Rated Tennis Elbow Evaluation (PRTEE) score at 6 month post-procedure.
详细描述
STUDY DESIGN:
Phase II, prospective, two-arm, single-blind randomized controlled study.
SETTING:
Up to 64 patients (56 + 15% loss to follow-up) suffering from chronic lateral epicondylosis will be recruited by one of two orthopedists working in a specialized outpatient clinic, at the Centre Hospitalier de l'Université de Montréal (CHUM), a tertiary care academic center. Ultrasound examination of the elbow will be performed before the interventions.
RANDOMIZATION:
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
- 30 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to read, understand and answer questionnaires in French or English
- •Diagnosis of unilateral, lateral epicondylosis established by an orthopaedist, determined by clinical presentation and pain, ≥ 4/10 on a pain numerical rating scale, on palpation of the region slightly anterior and distal to the lateral epicondyle, exacerbated by the extension of the wrist or the middle finger when the elbow is in extension.
- •Chronic epicondylosis, refractory to medical treatment conducted for at least six months, which includes rest and implementation of ergonomics to avoid soliciting the extensor tendons, and at least one of: physical therapy, a rehabilitation program with stretching and / or strengthening exercises, injection treatments (corticosteroids, autologous PRP) or extracorporeal shock waves.
排除标准
- •Suspected tumor or infectious etiology
- •Injection of corticosteroids during the last 3 months
- •Hemorrhagic diathesis; anticoagulation (platelets <50,000, International Normalized Ratio (INR) > 2)
- •Local infection
- •History of elbow surgery or fracture
- •History of inflammatory arthropathy
- •Neck pain and radiculopathy
- •Inability to provide informed consent because of a language problem, dementia or a major psychiatric disorder.
结局指标
主要结局
Patient Rated Tennis Elbow Evaluation
时间窗: Baseline and 6 months post-intervention
Proportion of patients with a change of at least 11/100 points in the score of the Patient Rated Tennis Elbow Evaluation - 6 months
次要结局
- Patient Rated Tennis Elbow Evaluation(Baseline and 6 weeks, 3 months, 12 months post-intervention)
- QuickDASH Work module(Baseline and 6 weeks, 3 months, 6 months and 12 months post-intervention)
- Medication Quantitative Scale(6 weeks, 3 months, 6 months and 12 months post-intervention)
- Level of satisfaction(6 weeks, 3 months, 6 months and 12 months post-intervention)
- Common Extensor Tendon Morphometric parameters measured at B-mode ultrasound(Baseline, 6 and 12 months post-intervention)
- Grip strength without pain(Baseline and 6 weeks, 3 months, 6 months and 12 months post-intervention)
- QuickDASH main module(Baseline and 6 weeks, 3 months, 6 months and 12 months post-intervention)
- Common Extensor Tendon Elasticity measured at ultrasound elastography(Baseline, 6 and 12 months post-intervention)
- RA-WIS questionnaire(Baseline and 6 weeks, 3 months, 6 months and 12 months post-intervention)
- Global Perception of Change(6 weeks, 3 months, 6 months and 12 months post-intervention)