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临床试验/NCT05867888
NCT05867888已完成不适用

Effect of Shock Wave Therapy Versus Low Level Laser Therapy in Patients With Plantar Fasciitis

Cairo University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2023年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
1
主要终点
Assess the change in pain pressure threshold

研究概览

简要总结

Both shock wave therapy and low level laser therapy in plantar fasciitis are effective in improvement of such cases without any side effects but there are no previously published studies on the use of shock wave therapy versus low level laser therapy in plantar fasciitis and, hence, evidence of its acceptability and effectiveness compared with each other remains to be established.

详细描述

Plantar fasciitis is a result of degenerative irritation of the plantar fascia origin at the medial calcaneal tuberosity of the heel as well as the surrounding perifascial structures, it is a common problem accounting for approximately one million patient visits per year, it is often an overuse injury. As a result tight gastrocnemius, soleus, and/or other posterior leg muscles have also been commonly found in patients with this condition.

Shock wave therapy is thought to provide long lasting analgesia and stimulate the healing process, Low level laser therapy has been used to relieve pain caused by plantar fasciitis, also stretching of the shortened and contracted plantar flexors may positively influence an individual's functional activities of daily living and decrease the risk of injury.

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)

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age ranges from 40-60 years old.
  • Both genders will be included.
  • Unilateral plantar fasciitis.
  • Duration of symptoms more than 4 weeks.
  • Positive Windlass test and negative Tinel and calcaneus squeeze tests.
  • Patients will be classified according to their BMI (18.5 - 24.9) kg/m2

排除标准

  • Open wound, infection in plantar surface of foot.
  • History of foot surgery.
  • History of trauma or fracture in foot or ankle.
  • Neuropathic pain as diabetes mellitus.
  • Peripheral vascular disease.
  • Calcaneal stress fracture or show evidence of a foreign body or tumor of the affected heel.
  • Previously suffered a rupture or surgery of the plantar fascia. Existing or prior osteomyelitis of the involved calcaneus.

研究组 & 干预措施

Experimental group 2

Experimental

Low level laser therapy + Conventional physical therapy.

干预措施: low level laser therapy (Other)

Experimental group 1

Experimental

Shock wave therapy + Conventional physical therapy.

干预措施: shock wave therapy (Other)

Experimental group 2

Experimental

Low level laser therapy + Conventional physical therapy.

干预措施: conventional therapy (Other)

Control group

Active Comparator

conventional physical therapy program (Instructions, Ice application, Deep tissue massage, Stretching exercises, Joint mobilization and isometric exercises).

干预措施: conventional therapy (Other)

Experimental group 1

Experimental

Shock wave therapy + Conventional physical therapy.

干预措施: conventional therapy (Other)

结局指标

主要结局

Assess the change in pain pressure threshold

时间窗: Before treatment and after 6 weeks treatment

Pressure algometry will be used to evaluate the pain pressure threshold for the two predetermined locations on the affected leg: gastrocnemius (middle point over the muscle belly) and soleus (center point of the muscle belly 10 cm above the Achilles tendon). The participant will speak up at the point where the pressure evoke a painful sensation. This process will be repeated 3 times in the same manner, and three measurements will be recorded at the same point on the plantar fascia. An average of the three readings will be recorded. Higher algometer scores indicate greater pressure threshold, therefore less tenderness. Lower algometer scores indicate less pressure threshold, thus more tenderness.

Assess the change in foot functional disability

时间窗: Before treatment and after 6 weeks treatment

Foot functional disability will be assessed by foot and ankle ability measure questionnaire (FAAM). Higher scores on the questionnaire indicate a higher level of physical functioning and lower scores on the questionnaire indicate a lower level of physical functioning.

Assess the change in pain intensity level

时间窗: Before treatment and after 6 weeks treatment

The visual analogue scale (VAS) is a widely utilized pain intensity level assessment instrument in patients with plantar fasciitis. The visual analogue scale (VAS) is typically composed of a horizontal line from zero (minimum value) to 10 (maximum value) where zero signifies (no pain) and 10 signifies (worst pain) one can imagine.

Assess the change in range of ankle motion

时间窗: Before treatment and after 6 weeks treatment

Ankle range of motion (ROM) will be measured by using digital goniometer (ankle dorsiflexion and plantarflexion ranges will be measured). It can monitor the progress of intervention.

Assess the change in ankle stability

时间窗: Before treatment and after 6 weeks treatment

The Human Assessment Computer (HUMAC) Balance System will be used in the current study to assess limits of stability of ankle joint.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Reham Mohamed Lotfy Soliman

principal investigator

Cairo University

研究点 (1)

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