Effectiveness of Ultrasound-Guided Percutaneous Electrical Stimulation on Radial Nerve With Exercises in Patients With Lateral Epicondylalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in Elbow Pain Intensity between baseline and follow-up periods
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 short, mid and long-term of PENS on intensity of pain as measured by numeric pain rating scale and disability as measured by Patient Rated Tennis Elbow Evaluation (PRTEE) 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 short, medium and long-term of PENS on disability as measured by DASH questionnaire, and psychological factors (fear and avoidance and catastrophism) and Global Rating of Change (GRoC) in patients with lateral epicondylalgia with random assignment to two treatments: PENS plus exercise program or Sham PENS plus exercise program.
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 65 Years（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.
研究组 & 干预措施
PENS plus exercise group
Experimental: PENS plus exercise group 4-week intervention program with 1 weekly treatment session, one of percutaneous electrical stimulation. In addition, self-management loaded exercise, prescribed by the physical therapist but completed by the patient independently . It involved isometric exercises, eccentric exercise, eccentric-concentric with weight or resistive therapeutic band.
干预措施: PENS plus exercise (Other)
Sham PENS plus exercise group
Sham Comparator: Sham PENS plus exercise group 4-week intervention program with 1 weekly treatment session, one of percutaneous electrical stimulation. In addition, self-management loaded exercise, prescribed by the physical therapist but completed by the patient independently. It involved isometric exercises, eccentric exercise, eccentric-concentric with weight or resistive therapeutic band.
干预措施: Sham PENS plus exercise (Other)
结局指标
主要结局
Changes in Elbow Pain Intensity between baseline and follow-up periods
时间窗: Baseline, 1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
Pain intensity measured with a 10 (0 - No pain - 10 The worst pain) numeric rating scale
次要结局
- Changes in Elbow Related-Disability between baseline and follow-up periods(Baseline,1 week post-intervention, and 1, 3, 6 and 12 months after the intervention)
- Changes in Upper Extremity Related-Disability between baseline and follow-up period(Baseline, 1 week post-intervention, and 1, 3, 6 and 12 months after the intervention)
- Changes in Kinesiophobia between baseline and follow-up periods(Baseline,1 week post-intervention, and 1, 3, 6 and 12 months after the intervention)
- Changes in Self-perceived Improvement between baseline and follow-up periods(Baseline,1 week post-intervention, and 1, 3, 6 and 12 months after the intervention)
- Changes in Pain Catastrophizing between baseline and follow-up periods(Baseline, 1 week post-intervention, and 1, 3, 6 and 12 months after the intervention)