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)

Mahidol University

Status and phase: Not yet enrolling; Phase 2

Conditions: Plantar Fasciitis

Treatments: Device: High power Laser therapy; Device: Focused extracorporeal shock wave therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07287046

MURA2025/885

Ramathibodi Hospital

Details and patient eligibility

About

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.

Enrollment: 14 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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14 participants in 2 patient groups

HILT group

Experimental group

Description:

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.

Treatment:

Device: High power Laser therapy

fESWT group

Active Comparator group

Description:

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)

Treatment:

Device: Focused extracorporeal shock wave therapy