About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
High power Laser therapy
DeviceHigh-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
DeviceFocused 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 groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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
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.
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.
Adverse events
Including post-treatment soreness, burns, a burning sensation, and hematoma
Locations
Sponsors and contacts
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