Effectiveness of Invasive Electrostimulation Combined With an Exercise Program in Plantar. A Clinical Trial
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
- Change from baseline in pain scores on the visual analogue scale at 6 weeks in patients with plantar fasciitis.
研究概览
简要总结
This study evaluates the effectiveness of an electrostimulation treatment with TENS using a needle and a surface electrode combined with an exercise program to fasciitis plantar. Half participants will receive invasive electrostimulation (TENS using a needle) and exercises while the other half will receive electrostimulation placebo and exercises.
详细描述
There are a lot of treatments to fasciitis plantar. Exercises are the treatments more recommended to fasciitis plantar but not all patients improve only with exercises. Dry needling is recommended to relieve the pain in the heel. TENS is used to decrease the pain in the fasciitis plantar. Investigators will apply to half participants a treatment that combines TENS + Dry needling (invasive electrostimulation ) with exercises while the other half receive electrostimulation placebo (TENS using surface electrodes with non-therapeutic intensity) + exercises.
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 (Investigator)
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
- •Medical diagnosis of plantar fasciitis
- •Age equal or superior to 18 years old.
- •VAS minimum of 2 points int the first steps after a prolonged decreasing period.
- •Having an evolution of a month or more of pain.
- •Not having received acupuncture or dry needling as treatment.
排除标准
- •Peripheral Neuropathies.
- •Tarsus tunnel syndrome.
- •Rheumatic diseases.
- •Contraindication to dry needling: nickel allergy, fear of needles, sky with erosions.
- •Clotting disorders such as thrombosis or thrombophlebitis.
- •Fractures, infections and/ or tumor processes.
- •Have been treated for plantar fasciitis in the las 4 weeks.
- •Previous surgery in the foot
- •Pregnancy.
- •Communication Disorders.
- •Holders of pacemakers or electrostimulators.
研究组 & 干预措施
Invasive electrostimulation combined with exercises.
Dry needling + TENS ( 4 Hz 200 microseconds during 30 minutes to therapeutic intensity) combined with exercises program.
干预措施: Invasive electrostimulation combined with exercises (Procedure)
Placebo electrostimulation and exercises.
Sham dry needling + TENS ( 4 Hz 200 microseconds during 30 minutes to non-therapeutic intensity) with surface electrodes combined with exercises program.
干预措施: Placebo electrostimulation and exercises (Procedure)
结局指标
主要结局
Change from baseline in pain scores on the visual analogue scale at 6 weeks in patients with plantar fasciitis.
时间窗: 6 weeks
It will evaluate the pain with Visual Analogue Scale in the first step in the first and tenth session. At 6 weeks, a new measurement will be made.
次要结局
- Change in the functionality and quality of life of foot and ankle at 6 weeks from first session in patients with plantar fasciitis.(6 weeks)
- Change in strength scores at 6 weeks from first session in patients with plantar fasciitis.(6 weeks)
- Change in the pain in the Trigger points at 6 weeks from first session in patients with plantar fasciitis.(6 weeks)
- Change in the functionality of foot and ankle at 6 weeks from first session in patients with plantar fasciitis.(6 weeks)