NCT07462169

Brief Summary

The purpose of the study is to

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

March 10, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2026

Completed
Last Updated

May 14, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

March 5, 2026

Last Update Submit

May 12, 2026

Conditions

Plantar Fasciitis

Keywords

High power pain Threshold UltrasoundHigh Intensity Laser therapyplantar fasciitis (PF)HILT

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (3)

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

Device: High intensity laser therapyOther: Conventional treatment

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

Device: High power pain threshold ultrasoundOther: Conventional treatment

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

Other: Conventional treatment

Interventions

High power pain threshold ultrasoundDEVICE

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

Arm 2 → High power pain threshold ultrasound
High intensity laser therapyDEVICE

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

Arm 1 → High intensity laser therapy
Conventional treatmentOTHER

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

Arm 1 → High intensity laser therapyArm 2 → High power pain threshold ultrasoundArm 3 → Conventional treatment

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Outpatient clinic of Faculty of Physical Therapy Benha National University.

Banhā, Egypt

RECRUITING

Faculty of Physical Therapy Benha National University.

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator

Study Record Dates

First Submitted

March 5, 2026

First Posted

March 10, 2026

Study Start

March 10, 2026

Primary Completion

May 5, 2026

Study Completion

May 20, 2026

Last Updated

May 14, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)