Comparison of the Efficacy of Low Intensity ESWT and Low Intensity LASER Therapy in the Treatment of Chronic Plantar Fasciitis; Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Visual Analog Scale
研究概览
简要总结
The aim of this study was to investigate the effects of extracorporeal shock wave therapy and low-intensity laser therapy on pain, functionality, plantar fascia thickness and balance in patients with plantar fasciitis.
详细描述
Plantar fasciitis is a pathology resulting from inflammation and/or degeneration of the plantar fascia of the sole of the foot. It affects about 10% of the population. It is one of the most common causes of chronic heel pain in the community and there is tenderness to palpation on the medial aspect of the heel bone. Patients complain of pain particularly with the first step in the morning and after rest. Mechanical overload and overuse can cause inflammation of the fascia. Diagnosis is usually made by clinical assessment and no further investigations are required.
In this study, 90 patients between the ages of 18 and 65 who meet the inclusion and exclusion criteria will be enrolled and participants will be randomised into 3 groups. The 1st group will be taught ESWT and home exercises for 1 session per week for 3 weeks and will be asked to do it every day. The 2nd group will receive 3 sessions of low intensity LASER per week for 3 weeks and will be asked to do home exercises every day. The 3rd group will only be taught home exercises and asked to do participants every day for 3 weeks. Visual analogue scale, foot function index, plantar fascia thickness measurement with USG and balance parameters will be measured at the beginning of the study, at the end of the treatment and at week 12.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients between 18 and 65 years of age, diagnosed with "plantar fasciitis" by anamnesis and physical examination
- •Complaint duration of at least 3 months
- •Patients who agree to participate in the study
排除标准
- •Complaint lasting less than 3 months
- •Injection in the heel area in the last 6 months
- •Use of physiotherapy modalities for the heel in the last 6 months
- •Bilateral complaint
- •Pregnancy
- •Malignancy
- •History of cardiac pacemaker
- •Anticoagulant use
- •History of systemic inflammatory disease
- •History of lower extremity fracture or surgery
- •Existing open wound in the heel area
- •Patient hypersensitivity
- •Systemic infection in the patient
- •Uncontrolled hypertension in the patient
- •Patient inability to cooperate
- •History of neuromuscular disease affecting balance parameters
- •Unwillingness of the patient to participate in the study
研究组 & 干预措施
Extracorporeal Shock Wave Therapy Group
By the same physiotherapist with more than 5 years of clinical experience, radial ESWT treatment with 2500 pulses, 10 Hz frequency, 2.5-3 bar pressure, is applied to the most painful point of the heel and surrounding soft tissues, plantar aponeurosis and Achilles tendon insertion area on the dorsum of the heel, once a week for a total of 3 sessions. Plantar fascia stretching exercises (exercises to stretch the membrane on the sole of the foot), gastrocsoleus stretching exercises (exercises to stretch the calf muscles), foot intrinsic muscle strengthening exercises (exercises to strengthen the muscles on the sole of the foot) are taught to the patients by the doctor and they are asked to perform them 2 times a day 10 times for a total of 3 weeks.
干预措施: Extracorporeal Shock Wave Therapy (Other)
Extracorporeal Shock Wave Therapy Group
By the same physiotherapist with more than 5 years of clinical experience, radial ESWT treatment with 2500 pulses, 10 Hz frequency, 2.5-3 bar pressure, is applied to the most painful point of the heel and surrounding soft tissues, plantar aponeurosis and Achilles tendon insertion area on the dorsum of the heel, once a week for a total of 3 sessions. Plantar fascia stretching exercises (exercises to stretch the membrane on the sole of the foot), gastrocsoleus stretching exercises (exercises to stretch the calf muscles), foot intrinsic muscle strengthening exercises (exercises to strengthen the muscles on the sole of the foot) are taught to the patients by the doctor and they are asked to perform them 2 times a day 10 times for a total of 3 weeks.
干预措施: EXERCİSE (Other)
Low Intensity Laser Group
A total of 28j (5.6jx5 points) are applied to the plantar fascia at 5 points on the heel by the same physiotherapist for 3 weeks, a total of 9 sessions (every other day) with the patient lying face down. Plantar fascia stretching exercises (exercises to stretch the membrane on the sole of the foot), gastrocsoleus stretching exercises (exercises to stretch the calf muscles), foot intrinsic muscle strengthening exercises (exercises to strengthen the muscles on the sole of the foot) are taught to the patients by the doctor and they are asked to perform them 2 times a day 10 times for a total of 3 weeks.
干预措施: Low Intensity Laser (Other)
Low Intensity Laser Group
A total of 28j (5.6jx5 points) are applied to the plantar fascia at 5 points on the heel by the same physiotherapist for 3 weeks, a total of 9 sessions (every other day) with the patient lying face down. Plantar fascia stretching exercises (exercises to stretch the membrane on the sole of the foot), gastrocsoleus stretching exercises (exercises to stretch the calf muscles), foot intrinsic muscle strengthening exercises (exercises to strengthen the muscles on the sole of the foot) are taught to the patients by the doctor and they are asked to perform them 2 times a day 10 times for a total of 3 weeks.
干预措施: EXERCİSE (Other)
Exercise Group
Exercise therapy is carried out by the patient for 3 weeks. Plantar fascia stretching exercises (exercises to stretch the membrane on the sole of the foot), gastrocsoleus stretching exercises (exercises to stretch the calf muscles), foot intrinsic muscle strengthening exercises (exercises to strengthen the muscles on the sole of the foot) are taught to the patients by the doctor and they are asked to perform them 2 times a day 10 times for a total of 3 weeks.
干预措施: EXERCİSE (Other)
结局指标
主要结局
Visual Analog Scale
时间窗: Before treatment (Week 0), at the end of treatment (Week 3) and after treatment (Week 12)
On the VAS (Visual Analogue Scale), pain intensity is usually rated from 0 for "no pain" to 10 for "the worst pain imaginable" (10 cm scale). Scoring intervals for pain intensity: \<3 mild pain, 3-6 moderate pain, \>6 severe pain. The VAS is a practical scale that is widely used in chronic pain worldwide. In this study it is evaluated as Visual Analog Scale-rest (VAS-I), Visual Analog Scale-first press (VAS-ib) and Visual Analog Scale-activity (VAS-a).
次要结局
- Foot Fonction Index(Before treatment (Week 0), at the end of treatment (Week 3) and after treatment (Week 12))
- Plantar Fascia Thickness Measurement with Ultrasound Imaging(Before treatment (Week 0) and after treatment (Week 12))
- Measurement of Balance Parameters in Biodex Balance Device(Before treatment (Week 0), at the end of treatment (Week 3) and after treatment (Week 12))
研究者
Esat POLAT
Principal Investigator
Ahi Evran University Education and Research Hospital