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临床试验/NCT07462169
NCT07462169已完成不适用

High Intensity Laser Versus High Power Pain Threshold Ultrasound in Treatment of Plantar Fasciitis

Cairo University2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2026年3月10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
51
试验地点
2
主要终点
Assessment of change of pain intensity

研究概览

简要总结

The purpose of the study is to

  1. Investigate the Effect of High-intensity laser therapy versus High power pain threshold ultrasound on pain level in patients with plantar fasciitis.
  2. Investigate the Effect of High intensity laser therapy versus High power pain threshold ultrasound on ROM in patients with plantar fasciitis.

详细描述

Plantar fasciitis (PF) is one of the most prevalent musculoskeletal disorders of the foot, affecting individuals across different age groups and activity levels. It is clinically characterized by localized pain at the medial aspect of the heel, typically exacerbated during weight-bearing activities, with marked intensity upon the first steps in the morning or following periods of prolonged rest or non-weight bearing. Persistent symptoms may significantly impair functional mobility and quality of life.

Among contemporary conservative management strategies, laser therapy has emerged as a promising non-invasive modality for PF treatment. Recently, High-Intensity Laser Therapy (HILT) has been introduced as an advanced therapeutic option. Due to its high peak power and deeper tissue penetration capability, HILT can effectively stimulate large and deep fascial structures, potentially enhancing tissue repair, modulating inflammation, and reducing pain perception.

High-Power Pain Threshold Ultrasound (HPPTUS) represents a modified therapeutic ultrasound technique that delivers energy at intensities approaching the patient's pain threshold. This approach aims to maximize deep tissue stimulation while maintaining patient tolerance. HPPTUS has demonstrated superior clinical outcomes compared to conventional ultrasound techniques, particularly in the management of myofascial pain syndrome, with significant reductions in pain intensity and improvements in range of motion (ROM) achieved within fewer treatment sessions.

The study aims to Investigate the Effect of High intensity laser therapy versus High power pain threshold ultrasound in the treatment of plantar fasciitis.

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
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • The patient age ranged from 30 to 60 years.
  • Plantar heel pain lasting for at least one month, mainly during the first few steps upon rising in the morning, which worsens with increased weight-bearing activity through the day.
  • Tenderness at the insertion site of the plantar fascia on the calcaneus.
  • Body mass index (MBI) <30 kg/m2

排除标准

  • Medical red flag history (such as tumor, fracture, heterotrophic ossification, and acute inflammatory disease in the ankle-foot area.
  • If the patient has history of recent trauma or foot surgery.
  • Wounds, infections in the treatment area.
  • Subjects with referred pain from sciatica and other neurological disorders.
  • History of corticosteroid injection in the last 6 months.

研究组 & 干预措施

Arm 2 → High power pain threshold ultrasound

Experimental

High power pain threshold ultrasound this group consists of 20 subjects will receive conventional treatment combined with high power pain threshold ultrasound , three times per week for one month

干预措施: Conventional treatment (Other)

Arm 3 → Conventional treatment

Active Comparator

conventional treatment this group consists of 20 subjects will receive conventional treatment only, three times per week for one month

Interventions:

Conventional treatment

干预措施: Conventional treatment (Other)

Arm 1 → High intensity laser therapy

Experimental

High Intensity Laser therapy this group consists of 20 subjects will receive conventional treatment combined with High-intensity laser therapy, three times per week for one month

干预措施: High intensity laser therapy (Device)

Arm 1 → High intensity laser therapy

Experimental

High Intensity Laser therapy this group consists of 20 subjects will receive conventional treatment combined with High-intensity laser therapy, three times per week for one month

干预措施: Conventional treatment (Other)

Arm 2 → High power pain threshold ultrasound

Experimental

High power pain threshold ultrasound this group consists of 20 subjects will receive conventional treatment combined with high power pain threshold ultrasound , three times per week for one month

干预措施: High power pain threshold ultrasound (Device)

结局指标

主要结局

Assessment of change of pain intensity

时间窗: At baseline and after 4 weeks of intervention

The Visual Analog Scale is a self-reported pain measurement scale with a 10-cm line labeling extreme pain levels. It is valid, reliable, and suitable for clinical practice. Studies have shown moderate to strong correlations for VAS validity in pain measurement.

次要结局

  • Assessment of change of pressure pain threshold(At baseline and after 4 weeks of intervention)
  • Assessment of change of Ankle Range of motion(At baseline and after 4 weeks of Intervention)
  • Assessment of foot pain and Functional Disability(At baseline and after 4 weeks of Intervention)

研究者

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

Sarah Khaled Attia Mohamed

Demonstrator

Cairo University

研究点 (2)

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