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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
28
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 (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)
Visual analog scale (VAS)
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
Time frame: Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment
VAS-FA Thai version
The parameter used to assess the level of pain in several foot activities, 0-100 point scale, a higher score means a better outcome
Time frame: Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment
Foot function index Thai version
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.
Time frame: Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment
Thickness of plantar fasciitis
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.
Time frame: Pre-treatment, and 12-week post-treatment
Adverse events
Including post-treatment soreness, burns, a burning sensation, and hematoma
Time frame: Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment
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