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Clinical Trials/NCT07462169
NCT07462169CompletedNot Applicable

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

Cairo University2 sites in 1 country51 target enrollmentStarted: March 10, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
51
Locations
2
Primary Endpoint
Assessment of change of pain intensity

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
30 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Arms & Interventions

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

Intervention: 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

Intervention: 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

Intervention: 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

Intervention: 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

Intervention: High power pain threshold ultrasound (Device)

Outcomes

Primary Outcomes

Assessment of change of pain intensity

Time Frame: 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.

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sarah Khaled Attia Mohamed

Demonstrator

Cairo University

Study Sites (2)

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