Effectiveness of a Combined Treatment Percutaneous Electrical Stimulation on Radial Nerve With an Exercise Program in Patients With Lateral Epicondylalgia
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Pain Intensity: visual analogue scale
研究概览
简要总结
Lateral epicondylalgia is a common musculoskeletal condition that approximately affects 1-3% of the general population. Several authors have found greater mechanical pain sensitivity in the radial nerve when compared with healthy subjects. Radial tunnel syndrome exhibits a similar clinical presentation to lateral epicondylalgia. Percutaneous electrical stimulation has shown reduce pain in several conditions. Percutaneous electrical stimulation on the radial nerve could cause an important relief in lateral epicondylalgia.
Hypothesis: Percutaneous electrical stimulation on radial nerve plus exercise therapy in patients with lateral epicondylalgia is better than sham percutaneous electrical stimulation plus exercise.
详细描述
Randomized, double-blind, placebo controlled clinical trial, using Percutaneous Electrical Nerve Stimulation (PENS). PENS is technique to provide a transcutaneous electrical nerve stimulation current throughout needling filaments place close to the nerve.
Study Aims:
Aim #1: The primary aim of the study is to compare the effect of the immediate, short, medium and long-term of PENS on intensity of pain as measured by visual analogue scale (VAS) in patients with lateral epicondylalgia with random assignment to two treatments: PENS plus exercise program or Sham PENS plus exercise program.
Aim #2: The secondary aim of the study is to compare the effect of the immediate, short, medium and long-term of PENS on pain free grip strength, disability as measured by Patient Rated Tennis Elbow Evaluation (PRTEE) and DASH questionnaire and pressure pain threshold (PPT) and area and distribution of pain in patients with lateral epicondylalgia with random assignment to two treatments: PENS plus exercise program or Sham PENS plus exercise program, and determine if psychological factors (fear and avoidance and catastrophism) change with any of the treatments and if is related with the primary and secondary outcomes.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lateral epicondylalgia symptoms confirmed with at least 2 of the 4 following test:
- •pain during palpation of lateral epicondyle
- •pain on resisted wrist extension
- •pain on resisted middle finger extension
- •pain during hand-grip.
排除标准
- •History of fractures, luxations, surgery and/or musculoskeletal disorders in upper limb.
- •Neurological disorders, inflammatory and/or degenerative diseases.
- •Having received as treatment techniques that involve needles on the previous 6 months to study enrollment, or having received percutaneous electrical stimulation as a treatment before.
- •Cervical pathology, fibromyalgia, unstable cardiovascular diseases, pregnant women or under suspect of pregnancy.
- •Contraindications of needle's insertions: anticoagulant therapy, needle phobia, diabetes, hypothyroidism, lymphoedema, muscular diseases).
- •Contraindications of electrical current application.
结局指标
主要结局
Pain Intensity: visual analogue scale
时间窗: Change from baseline to immediate (single session); 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks
Pain intensity measured with a 100mm (0 - No pain - 100 The worst pain) visual analogue scale
次要结局
- Area of pain(Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks)
- Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire(Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks)
- Pain free grip strength(Change from baseline to immediate (single session); 4 weeks; 8 weeks; 16 weeks; 28 weeks)
- Pain distribution(Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks)
- Kinesiophobia(Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks)
- Pain catastrophizing(Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks)
- Patient Rated Tennis Elbow Evaluation (PRTEE)(Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks)
- Pressure pain threshold using an algometer(Change from baseline to immediate (single session); 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks)