Low-Level Laser Therapy for Plantar Fasciitis

NACompletedINTERVENTIONAL
Enrollment

71

Participants

Timeline

Start Date

August 11, 2022

Primary Completion Date

October 31, 2024

Study Completion Date

October 31, 2024

Conditions
Plantar Fascitis
Interventions
DEVICE

Photobiomodulation Therapy (PBMT)

Participants will receive PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments will take approximately 5-10 minutes to administer at each session. Specific treatment parameters will be based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants will receive 10 J/cm2, 25W output power, and the length of the treatment will be dependent on treatment area (size). PBMT will be administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members will use the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback.

DEVICE

Sham-Photobiomodualtion Therapy (Sham-PBMT)

Sham-PBM treatment time will be calculated in the same way as the PBM treatment group, with the time of treatment dependent on the size of the treatment area. The sham-PBMT will be administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin. Because emission of photons at the selected treatment parameters may cause participants in the treatment group to feel warmth, the massage ball will be warmed in the sham-PBMT. The device will be turned on, so the red aiming beam will be visible, but the operator will not activate the switch to emit photons.

Trial Locations (1)

98431

Madigan Army Medical Center, Tacoma

All Listed Sponsors
collaborator

Uniformed Services University of the Health Sciences

FED

collaborator

Musculoskeletal Injury Rehabilitation Research for Operational Readiness

FED

lead

The Geneva Foundation

OTHER