Short and Long Term Effect of High Intensity Versus Low-Level Laser Therapy in Treatment of Patients With Achilles Tendinitis or Plantar Fasciitis: A Single Blinded Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 2
- 主要终点
- Pain - visual analog scale
研究概览
简要总结
The aim of this study is to evaluate and compare the changes of heel pain, functional health and well-being after high-intensity and low-level laser therapy for plantar fasciitis or Achilles tendinopathy
详细描述
Plantar heel pain, also known as plantar fasciitis, causes soreness or tenderness of the sole of the foot under the heel, which sometimes extends into the medial arch. Pain associated with the condition may cause substantial disability and poor health-related quality of life. Achilles tendinitis is a common etiology of posterior heel pain that results in significant pain and loss of function. Calf exercise is initial management that may be supported by laser therapy. A treatment possibility high-intensity laser therapy is little explored. High-intensity lasers can deliver more energy deeper into tissue. The hypothesis is that both lasers are effective in treatment of plantar fasciitis or Achilles tendinopathy, but high-intensity laser therapy is more effective.
The aim of this study is to evaluate and compare the changes of heel pain, functional health and well-being after high-intensity and low-level laser therapy for plantar fasciitis or Achilles tendinopathy.
The study was approved by Committee on Biomedical Research Ethics of Kaunas Region (2016-07-14 No. BE-2-32). Patients are recruited in out patient clinic of Physical Medicine and Rehabilitation Department in The Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos.
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 (Participant)
盲法说明
Participants were informed that they will receive treatment with laser. Participants were not informed which laser (HILT or LLLT) was administered.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •unilateral painful activity related symptoms from the Achilles region
- •tenderness during palpation of Achilles insertion on calcaneus or couple centimeters above
- •unilateral plantar heel pain, mainly during the first few steps upon rising in the morning
- •tenderness at the insertion site of the plantar fascia o the calcaneus
排除标准
- •bilateral heel pain
- •other acute pathology (febrile fever, cold. etc.) that require treatment
- •other painful conditions that require painkillers (tooth pain, back pain, etc)
- •pregnancy
- •history of recent trauma or foot surgery
- •wounds, infections in treatment area
- •impaired sensation in treatment area
- •pigmentation changes on the skin in treatment area (tattoo, birthmarks)
- •received oral or injected corticosteroids within the last 26 weeks
- •diagnosis of systemic inflammatory arthritis (goat, rheumatoid arthritis, etc)
- •diagnosis of neurological heel pain (radiculopathy)
- •diagnosis of other heel pathology (calcaneal stress fracture, osteomyelitis, plantar fascia neoplasm, plantar fascia rupture, etc)
结局指标
主要结局
Pain - visual analog scale
时间窗: 4 weeks follow up
Visual analog scale from 0 to 100 mm ("0" = no pain, "100" = the most intense pain). Heel pain in specific day time (at rest, first morning step, several minutes after first step, first step after prolonged sitting in the middle of the day, in the evening and at night)
次要结局
- Pain - numerical pain rating scale(Baseline to 3, 5, 8, 10, 12, 15 and 17 days (before every laser procedure))
- Range of motion - goniometry(Baseline to 3 weeks and 4 weeks follow up)
- Tendon thickness measurement - ultrasound(Baseline to 3 weeks and 4 weeks follow up)
- Evaluation of functional condition of patients' feet - Foot Function Index-Revised Short Form(Baseline to 3 weeks and 4 weeks follow up)
- Functional health and well-being - SF-36v2®(Baseline to 3 weeks and 4 weeks follow up)
- Pain - pressure algometry(Baseline to 3 weeks and 4 weeks follow up)
- Evaluation of functional condition of patients' feet - Foot and Ankle Ability Measure(Baseline to 3 weeks and 4 weeks follow up)
研究者
Dovile Naruseviciute
Doctor of Medicine, investigator
Lithuanian University of Health Sciences