Comparative Effects of Therapeutics Ultrasound and Shockwave Therapy on Pain and Quality of Life in Patients With Chronic Heel Spur Pain. A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
This research aims to compare the effectiveness of therapeutic ultrasound (TUS) and extracorporeal shockwave therapy (ESWT) in managing chronic heel spur pain and improving patients' quality of life. Chronic heel spur pain, often associated with plantar fasciitis, is a debilitating condition that affects mobility and daily activities.
详细描述
The study will be conducted at Sehat Medical Complex, Lahore, over 10 months, enrolling 60 participants diagnosed with chronic heel spur pain. They will be randomly assigned into two groups: one receiving therapeutic ultrasound (10 sessions over two weeks with a frequency of 1 MHz and intensity between 0.8-2.0 W/cm²) and the other undergoing shockwave therapy (five weekly sessions with 2500 shocks per session at increasing pressure levels from 2.5 to 3.5 bars). The effectiveness of these interventions will be evaluated using the Visual Analog Scale (VAS) for pain intensity, the Foot Function Index (FFI) for functional assessment, and for quality of life. Follow-up assessments will be conducted at baseline, after the intervention (week 4), and at week 8 to evaluate both short-term and sustained treatment effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with chronic heel spur pain, confirmed through imaging studies (e.g., X-ray, ultrasound).
- •Age range: 30-60 years. Both male and female included
- •Chronic heel pain persisting for more than 1 month.
- •Individuals with no prior surgical intervention for heel pain.
- •Ability to provide informed consent and comply with the treatment protocol.
排除标准
- •Presence of systemic inflammatory conditions such as rheumatoid arthritis or gout.
- •History of previous steroid injection less than 6 weeks.
- •prior NSAID treatment less than 1 week,
- •Individuals with contraindications to ultrasound or shockwave therapy, such as pacemakers or implanted devices.
研究组 & 干预措施
Therapeutic ultrasound
干预措施: Therapeutic ultrasound (Combination Product)
Shockwave Therapy
干预措施: Shockwave Therapy (Combination Product)
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: 12 Months
A Visual Analogue Scale (VAS) is one of the pain rating scales. Pain intensity can be categorized based on VAS scores, with mild pain typically ranging from 1-3, moderate pain from 4-6, and severe pain from 7-10. Validity is 0.95% and reliability is 0.88%. Foot Function Index (FFI): A Foot Function Index (FFI) is to measure the impact of foot pathology on function in terms of pain, disability and activity restriction. The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales. Validity is 0.90% and reliability is 0.85%.
Quality Of Life
时间窗: 12 Months
The 36-Item Short Form Survey (SF-36) is an outcome measure instrument that is often used, well-researched, self-reported measure of health. Each scale is directly transformed into a 0-100 scale. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
次要结局
未报告次要终点
研究者
Muhammad Naveed Babur
Principal Investigator
Superior University