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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMahidol University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • High power Laser therapy

    Device

    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

    Device

    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 groups

28 Participants
are divided into 2 treatment groups
Group A: HILT groupExperimental treatment 1 intervention
Group B: fESWT groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: