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Completed

NCT Number: NCT07462169

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

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.

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Key information

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient clinic of Faculty of Physical Therapy Benha National University., Banhā, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High intensity laser therapy

Device

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

High power pain threshold ultrasound

Device

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

conventional treatment

Other

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

Primary outcomes

  1. 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

  1. Assessment of change of pressure pain threshold

    Time frame: At baseline and after 4 weeks of intervention

    A pressure algometer is a reliable tool for determining local pressure pain threshold (PPT) in different pain syndromes. It is a force gauge calibrated in kg/cm2 and has a range of 0-10 kg/cm2. A manual pressure algometer will be used to measure pain threshold for heel, with repeated measurements to improve reliability.

  2. Assessment of change of Ankle Range of motion

    Time frame: At baseline and after 4 weeks of Intervention

    Electronic goniometer will be used to differentiate changes in ROM. Electronic goniometer was used to evaluated ankle ROM in dorsiflexion and plantar flexion.

  3. Assessment of foot pain and Functional Disability

    Time frame: At baseline and after 4 weeks of Intervention

    The Foot Function Index (FFI) is a validated questionnaire used to evaluate foot pain and functional disability. It includes 23 items assessing pain, disability, and activity limitation. Each item is rated on a scale from 0 to 10, with higher scores indicating greater pain and functional limitation.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Acronym: HILT - HPPTUS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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