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NCT Number: NCT07287046

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

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.

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Key information

Conditions

Plantar Fasciitis Fasciitis Fasciitis, Plantar Foot Diseases Musculoskeletal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

High power Laser therapy

Device

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

Focused extracorporeal shock wave therapy

Device

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)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Peerada Eurcherdkul, Doctor of Medicine

CONTACT

[email protected]

+6692-272-0652

Suttinon Jitjai, Dortor of Medicine

CONTACT

+89-463-3401

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Acronym: HILT

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Dec 16, 2025
Registry last updated
Mar 25, 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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