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

Официальное название

A Comparison of Efficacy Between High-intensity Laser Therapy and Focused Extracorporeal Shock Wave Therapy in Patient With Plantar Fasciitis; Single Blinded Randomize Controlled Study

Обзор

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.

Вмешательства

• Устройство High 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
• Устройство Focused extracorporeal shock wave therapy
  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)

Первичные конечные точки

• Visual analog scale (VAS) [Срок оценки: Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment]

Вторичные конечные точки (4)

• VAS-FA Thai version [Срок оценки: Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment]
• Foot function index Thai version [Срок оценки: Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment]
• Thickness of plantar fasciitis [Срок оценки: Pre-treatment, and 12-week post-treatment]
• Adverse events [Срок оценки: Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

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• Angthong C, Chernchujit B, Suntharapa T, Harnroongroj T. Visual analogue scale foot and ankle: validity and reliability of Thai version of the new outcome score in subjective form. J Med Assoc Thai. 2011 Aug;94(8):952-7. PMID 21863677
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Идентификаторы

NCT: NCT07287046 · MURA2025/885 · Ramathibodi Hospital

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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