High Intensity Laser VS High Power Pain Threshold Ultrasound in Treatment of Plantar Fasciitis (HILT - HPPTUS)

High Intensity Laser Versus 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.

Study Overview

• Status: Recruiting
• Conditions: Plantar Fasciitis
• Intervention / Treatment: Device: High intensity laser therapy; Other: Conventional treatment; Device: High power pain threshold ultrasound

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara K Ghoneem, Master degree; Phone Number: +201014883465; Email: sarakhaled27101997@gmail.com

Study Locations

• Egypt
  • Banhā, Egypt
    • Recruiting
    • Outpatient clinic of Faculty of Physical Therapy Benha National University.
    • Contact: Sara K Ghoneem, MD; Phone Number: +201014883465; Email: sara.khaled.pt@o6u.edu.eg
    • Contact: Doaa R Elazab, PHD; Phone Number: +201005591580; Email: doaa.rafat@pt.cu.edu.eg
  • Cairo, Egypt
    • Recruiting
    • Faculty of Physical Therapy Benha National University.
    • Contact: Sara K Ghoneem, MD; Phone Number: +201014883465; Email: sarakhaled27101997@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The patient age ranged from 30 to 60 years.
2. 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.
3. Tenderness at the insertion site of the plantar fascia on the calcaneus.
4. Body mass index (MBI) <30 kg/m2

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 → High intensity laser therapy; 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	Device: 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; Other: Conventional treatment; this group consists of 20 subjects will receive conventional treatment only, three times per week for one month
Experimental: Arm 2 → High power pain threshold ultrasound; 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	Other: Conventional treatment; this group consists of 20 subjects will receive conventional treatment only, three times per week for one month; Device: 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
Active Comparator: Arm 3 → Conventional treatment; conventional treatment this group consists of 20 subjects will receive conventional treatment only, three times per week for one month Interventions: Conventional treatment	Other: Conventional treatment; this group consists of 20 subjects will receive conventional treatment only, three times per week for one month

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of change of pain intensity	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.	At baseline and after 4 weeks of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of change of pressure pain threshold	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.	At baseline and after 4 weeks of intervention
Assessment of change of Ankle Range of motion	Electronic goniometer will be used to differentiate changes in ROM. Electronic goniometer was used to evaluated ankle ROM in dorsiflexion and plantar flexion.	At baseline and after 4 weeks of Intervention
Assessment of foot pain and Functional Disability	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.	At baseline and after 4 weeks of Intervention

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2026
• Primary Completion (Actual): May 5, 2026
• Study Completion (Estimated): May 20, 2026

Study Registration Dates

• First Submitted: March 5, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: HILT; High power pain Threshold Ultrasound; High Intensity Laser therapy; plantar fasciitis (PF)
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: P.T.REC/012/006276

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No