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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 28
- 主要终点
- Visual analog scale (VAS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Pain was localized and sharp but not radiating,
- •Pain was reproduced with palpation of the plantar fascia
排除标准
- •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
研究组 & 干预措施
HILT group
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.
干预措施: High power Laser therapy (Device)
fESWT group
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)
干预措施: Focused extracorporeal shock wave therapy (Device)
结局指标
主要结局
Visual analog scale (VAS)
时间窗: 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
次要结局
- Adverse events(Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment)
- Thickness of plantar fasciitis(Pre-treatment, and 12-week post-treatment)
- VAS-FA Thai version(Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment)
- Foot function index Thai version(Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment)