A Single-Blind Randomized Controlled Study Comparing the Efficacy of High-Intensity Laser Therapy and Focused Extracorporeal Shock Wave Therapy in Patients With Plantar Fasciitis (HILT)

March 20, 2026 updated by: Mahidol University

A Comparison of Efficacy Between High-intensity Laser Therapy and Focused Extracorporeal Shock Wave Therapy in Patient With Plantar Fasciitis; Single Blinded Randomize Controlled Study

This randomized controlled trial aims to evaluate the efficacy of High-Intensity Laser Therapy (HILT) and Focused Extracorporeal Shock Wave Therapy (fESWT) in reducing pain in patients with plantar fasciitis. The study also examines the effects of HILT and fESWT on health-related outcomes, including VAS-FA, FFI, plantar fascia thickness, and adverse events.

Researchers will compare HILT with fESWT as treatment options for patients with plantar fasciitis.

Participants will receive either HILT or fESWT along with an exercise program. They will attend follow-up visits to assess outcomes at 1, 2, 3, 6, and 12 weeks after the first treatment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Peerada Eurcherdkul, Doctor of Medicine
  • Phone Number: +6692-272-0652
  • Email: eurpeerada@gmail.com

Study Contact Backup

  • Name: Suttinon Jitjai, Dortor of Medicine
  • Phone Number: +89-463-3401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 18-70 years
  • Pain was worse in the initial step after and an extended period of rest
  • Pain was decreased initially after the first steps but exacerbated with increased activity
  • VAS ≥ 4
  • Pain was localized and sharp but not radiating,
  • Pain was reproduced with palpation of the plantar fascia

Exclusion Criteria:

  • Have Wound/Infection/tumor in treatment area
  • History of foot trauma in 3 months
  • History of intervention at plantar fascia in 6 months such as Ultrasound therapy, steroid injection, surgery or botulinum toxin injection
  • Pain medication within one week before participation
  • Patient wasn't desired to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HILT group
High-power laser therapy (iLUX® XP) was applied using a power output of 6 W, an energy density of 5 J/cm², and a spot size of 10 cm², delivering a total energy of 150 J per session. Treatment consisted of 6 sessions, administered twice per week for 3 weeks.
Device: High power Laser therapy
High-power laser therapy (iLUX® XP) was applied using a power output of 6 W, an energy density of 5 J/cm², and a spot size of 10 cm², delivering a total energy of 150 J per session. Treatment consisted of 6 sessions, administered twice per week for 3 weeks
Active Comparator: fESWT group
Focused extracorporeal shock wave therapy (fESWT) using the DUOLITH® SD1 (STORZ Medical) was applied at a frequency of 4 Hz, starting at an energy flux density of 0.2 mJ/mm² and gradually increased as tolerated. Each session consisted of 2,000 shocks, for a total of 3 sessions (one session per week)
Device: Focused extracorporeal shock wave therapy
Focused extracorporeal shock wave therapy (fESWT) using the DUOLITH® SD1 (STORZ Medical) was applied at a frequency of 4 Hz, starting at an energy flux density of 0.2 mJ/mm² and gradually increased as tolerated. Each session consisted of 2,000 shocks, for a total of 3 sessions (one session per week)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analog scale (VAS)
Time Frame: Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment
a pain rating scale based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm) Measurements from the starting point (left end) of the scale to the patients' marks are recorded in centimeters and are interpreted as their pain
Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thickness of plantar fasciitis
Time Frame: Pre-treatment, and 12-week post-treatment
The plantar fascia thickness was measured at the point of plantar fascial insertion into the calcaneus with ultrasound machine in longitudinal view of tendon in both affected and healthy feet (mm). The quantitative measurement was achieved by recording the thickest part measured.
Pre-treatment, and 12-week post-treatment
Adverse events
Time Frame: Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment
Including post-treatment soreness, burns, a burning sensation, and hematoma
Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment
VAS-FA Thai version
Time Frame: Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment
The parameter used to assess the level of pain in several foot activities, 0-100 point scale, a higher score means a better outcome
Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment
Foot function index Thai version
Time Frame: Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment
a self-reporting questionnaire covering several dimensions of foot function categorized in 3 subscales that quantify the impacts of foot problems on pain, disability and activity limitation. FFI use a horizontal numeric block rating scale with 10 equal size boxes ranging from 0 to 9. A higher score indicates a higher severity.
Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 28, 2026

Primary Completion (Estimated)

December 25, 2026

Study Completion (Estimated)

February 20, 2027

Study Registration Dates

First Submitted

December 3, 2025

First Submitted That Met QC Criteria

December 3, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MURA2025/885
  • Ramathibodi Hospital (Other Identifier: Ramathibodi Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared. Data will be analyzed and reported only in aggregate form in scientific publications, including baseline characteristics and study outcomes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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