Plantar Fasciitis
Conditions
Brief summary
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.
Interventions
DEVICEHigh power Laser therapy
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)
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analog scale (VAS) | 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
| Measure | Time frame | Description |
|---|---|---|
| VAS-FA Thai version | 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 |
| Foot function index Thai version | 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. |
| Thickness of plantar fasciitis | 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. |
| Adverse events | Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment | Including post-treatment soreness, burns, a burning sensation, and hematoma |
Contacts
CONTACTPeerada Eurcherdkul, Doctor of Medicine
CONTACTSuttinon Jitjai, Dortor of Medicine
Outcome results
None listed