A Randomized Controlled Trial Comparing Two Protocols of Shock Wave Therapy for Patients With Plantar Fasciitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 64
- 主要终点
- Pain Reduction
研究概览
简要总结
The goal of this clinical trial is to compare the efficacy of two distinct shock wave therapy protocols and their impact on improving function and reducing pain in individuals with plantar fasciitis, a common cause of heel pain that affects millions worldwide.
The key questions the study aims to address are:
How effective is each shock wave therapy protocol in enhancing functional ability without pain in patients with plantar fasciitis? Does either protocol offer a significant benefit over the other in terms of pain relief and functional improvement after a course of six treatment sessions?
Participants will be randomly assigned to one of three groups and will engage in the study as follows:
Undergo six sessions of shock wave therapy with parameters specific to their assigned group.
Complete questionnaires assessing foot function and pain levels. Participate in evaluations before, during, and after the treatment to monitor their progress.
The three groups in the comparison are as follows:
Group A will receive shock wave therapy at a higher frequency and specific intensity, with a set number of impulses.
Group B will undergo therapy with a different frequency and intensity level but will receive the same number of impulses.
Group C, the control group, will receive a sham therapy, mirroring the treatment experience without the therapeutic effects to serve as a baseline for comparison.
The study is anticipated to delineate a more effective protocol for treating plantar fasciitis with shock wave therapy. The findings may contribute to enhanced treatment guidelines, potentially resulting in faster recovery times for patients. The participation of individuals in this research will offer valuable insights that could inform future therapeutic strategies for managing plantar fasciitis
详细描述
This randomized controlled trial is designed to evaluate the efficacy of two distinct shock wave therapy protocols in treating plantar fasciitis, a condition that causes heel pain and can severely impact daily activities. The aim is to discern which protocol is more effective at improving functional abilities and reducing pain.
Plantar fasciitis typically manifests as a sharp pain at the bottom of the heel, often affecting individuals who engage in high-impact activities such as running. With the variability in treatment approaches, shock wave therapy has been recognized as a promising, non-invasive treatment method. The study seeks to address the current gaps in research by identifying the most beneficial treatment parameters of shock wave therapy.
Participants will be randomly allocated to one of three groups:
Group A will receive shock wave therapy with high-frequency settings. Group B will receive shock wave therapy with low-frequency settings but higher intensity.
Group C will serve as a control group, receiving sham shock wave therapy to provide a baseline for comparison.
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 (Participant)
盲法说明
In a randomized trial, two shock wave therapies for plantar fasciitis are tested. Group A gets high-frequency (15 Hz), Group B low-frequency (10 Hz, higher intensity), and Group C receives sham therapy. The study aims to measure pain relief and functional gains post six treatments, with follow-ups to assess benefits' persistence.
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participants should present with unilateral pain
- •The participants' age will be ranged from 20-50 years old.
- •The participants should have the pain from for at least 6 weeks.
- •Moderate disability as assessed by the foot function index (FFI)
- •The Body Mass Index (BMI) should be normal.
- •The participants should have pronated feet (6-9 on the foot posture index)
排除标准
- •History of surgery or fracture
- •History of corticosteroid injection within 6 months
- •Unable to follow or understand the instructions
- •Severe foot pronation (+10 on the foot posture index)
结局指标
主要结局
Pain Reduction
时间窗: Baseline: Assessment before the start of intervention (Week 0). Mid-Point: After the 3rd session (end of Week 3). End of Treatment: After the 6th session (end of Week 6). Follow-Up: 12 weeks post-intervention (end of Week 18).
Evaluate the decrease in heel pain as measured by the Visual Analog Scale (VAS).
次要结局
- Functional Improvement(Baseline: Assessment before the start of intervention (Week 0). Mid-Point: After the 3rd session (end of Week 3). End of Treatment: After the 6th session (end of Week 6). Follow-Up: 12 weeks post-intervention (end of Week 18).)
研究者
Fatima Alkalbani
Student
University of Sharjah