Comparison of the Effectiveness of Dextrose Prolotherapy and Extracorporeal Shock Wave Therapy (ESWT) in Plantar Fasciitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Change in Heel Pain Intensity (VAS Score)
研究概览
简要总结
Plantar fasciitis is a degeneration of the plantar aponeurosis and is the most common cause of heel pain (11-15%). Although seen in both sexes, plantar fasciitis is more common in women, usually unilateral and bilateral in 30% of cases . The most widely accepted view regarding the formation of plantar fasciitis is that it is a degenerative process caused by myxoid degeneration, microtears, collagen necrosis, and angiofibroblastic hyperplasia, resulting from repetitive microtrauma to the plantar fascia, particularly at the calcaneal insertion site. It is not inflammatory . The purpose of this study was to compare the effectiveness of prolotherapy, a regenerative treatment, and ESWT in the treatment of plantar fasciitis.
详细描述
Plantar fasciitis is known as the most common cause of heel pain in adults. While its incidence increases between the ages of 40 and 60, it is more common in runners, those who work in positions requiring prolonged standing, overweight individuals, and those with certain biomechanical foot problems. Diagnosis of plantar fasciitis can be easily made through history and physical examination. Conservative methods are the first line of treatment. Local injections and ESWT are used in patients who fail to improve despite conservative treatment. ESWT and Prolotherapy are treatment methods that induce regeneration by creating a controlled inflammation. This prospective study aims to compare the effectiveness of ESWT and Prolotherapy, which have similar mechanisms of action, in the treatment of plantar fasciitis and to identify the more effective method.
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)
盲法说明
The outcome assessor will be blinded to treatment allocation. Participants and care providers will be aware of the intervention due to the nature of the treatments.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of plantar fasciitis
- •Ages 18 to 75 years
- •Both male and female participants
- •Heel pain localized to the medial calcaneal tubercle for more than 3 months
- •Morning first-step pain and pain increasing with daily loading
- •Willingness to participate and provide written informed consent
- •Patients presenting to Kanuni Sultan Süleyman Training and Research Hospital
排除标准
- •Cardiac pacemaker
- •Type 1 or Type 2 diabetes mellitus
- •History of inflammatory rheumatic disease
- •Bleeding disorders
- •Use of anticoagulant medications other than aspirin
- •Allergy to dextrose
- •Previous foot or ankle surgery
- •Peripheral neuropathy
- •S1 radiculopathy in the same extremity
- •Local corticosteroid injection to the plantar fascia within the last 3 months
- •ESWT applied to the plantar fascia within the last 3 months
- •Physical therapy applied to the foot/ankle in the last 3 months
- •Cognitive dysfunction
- •Active infection at the planned injection site
研究组 & 干预措施
Dextrose Prolotherapy
Participants in this group will receive dextrose prolotherapy twice, at two-week intervals.
A 5 mL syringe will be prepared with 2.5 mL of 30% dextrose, 2 mL of isotonic saline, and 0.5 mL of 2% lidocaine (final 15% dextrose solution).
Injections will be administered into seven points around the plantar fascia origin and insertion under aseptic conditions.
干预措施: Dextrose Prolotherapy (Procedure)
Extracorporeal Shock Wave Therapy (ESWT)
Participants in this group will receive extracorporeal shock wave therapy (ESWT) twice per week for a total of four sessions.
The treatment will be applied to the plantar fascia insertion using a standard clinical ESWT device following manufacturer guidelines.
干预措施: Extracorporeal Shock Wave Therapy (ESWT) (Device)
结局指标
主要结局
Change in Heel Pain Intensity (VAS Score)
时间窗: Baseline, 6 weeks, 12 weeks
Heel pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS) at baseline, 6 weeks, and 12 weeks. The primary outcome is the change in VAS score from baseline to week 12 in each treatment group.
Change in Heel Pain Intensity (VAS Score)
时间窗: Baseline, 6 weeks, 12 weeks
Heel pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS) at baseline, 6 weeks, and 12 weeks. The primary outcome is the change in VAS score from baseline to week 12 in each treatment group.
次要结局
- Change in Foot Function Index (FFI) Total Score(Baseline, 6 weeks, 12 weeks)
- Change in Roles and Maudsley Score(Baseline, 6 weeks, 12 weeks)
- Change in Foot Function Index (FFI) Total Score(Baseline, 6 weeks, 12 weeks)
- Change in Roles and Maudsley Score(Baseline, 6 weeks, 12 weeks)
研究者
Zeynep Karakuzu Güngör
Physical Medicine and Rehabilitation
Kanuni Sultan Suleyman Training and Research Hospital