Comparative Efficacy of Multiwave Locked System Laser, Extracorporeal Shockwave Therapy and Exercise Therapy on Plantar Fasciitis Outcomes: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
This study aims to evaluate the effectiveness of exercise combined with ESWT (Extracorporeal Shockwave Therapy), exercise combined with MLS (Multiwave Locked System) laser therapy, and exercise alone in female patients diagnosed with unilateral plantar fasciitis, using Visual Analog Scale (VAS), Heel Tenderness Index (HTI), Foot and Ankle Outcome Score (FAOS), Foot Function Index (FFI) and fall risk, as clinical parameters to assess any differences in effectiveness levels among these treatments.
详细描述
Plantar fasciitis (PF) is a prevalent condition characterized by the degeneration of the plantar fascia, a band of connective tissue that originates from the calcaneus to the proximal phalanges and the skin of the foot's anterior part. Despite common misconceptions, plantar fasciitis is not primarily an inflammatory process but results from repetitive microtears leading to a secondary inflammatory reaction of the plantar fascia.
Despite the condition's self-limiting nature, with 70% to 80% of patients experiencing symptom relief through conservative treatment alone, a combination of treatments is often necessary for many. Conservative interventions include rest, cold application, stretching and strengthening exercises, orthotic devices, lifestyle modifications, weight loss, and night splints. Additionally, non-invasive physical therapy modalities such as Extracorporeal Shock Wave Therapy (ESWT), laser, and ultrasound have shown to be cost-effective and accessible treatment options. Invasive treatments, including injections and surgery, are considered for resistant cases
Previous studies have examined the effectiveness of ESWT, Low level laser therapy, High intensity laser therapy, and exercise treatments in patients with PF, demonstrating their efficacy. Although there are studies investigating the effectiveness of MLS laser therapy on various musculoskeletal pathologies, to our knowledge, there is no study specifically examining its efficacy on PF
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 evaluation of outcomes was performed by an assessor blinded to the treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 18-65 years
- •Female gender
- •Symptoms persisting for at least 6 weeks
- •Unilateral plantar fasciitis
- •Consent to participate in the study
排除标准
- •Male gender
- •Bilateral plantar fasciitis
- •Treatment with ESWT, laser or injection therapy for plantar fasciitis in the previous year
- •Participation in a physical therapy program for plantar fasciitis in the last six months
- •History of systemic inflammatory disease
- •History of lower extremity fracture or surgery
- •Pregnancy
- •History of epilepsy
- •Malignancy
- •Active infection
- •Coagulation disorders
- •Severe cardiac disease or history of pacemaker
- •History of neuromuscular disease affecting balance parameters
- •Regular use of nonsteroidal antiinflammatory drugs
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: one month
VAS is a scale 10 cm in length, starting from "no pain" and ending with "unbearable pain" (0: no pain, 10: unbearable pain). Patients indicate the severity of their pain by marking the appropriate point on this scale. The distance between "no pain" and this marked point is measured and recorded in centimeters
次要结局
- Foot Function Index (FFI)(one month)
- Heel Tenderness Index (HTI)(one month)
- Biodex Fall Risk Assessment(one month)
- Foot and Ankle Outcome Score (FAOS)(one month)
研究者
Ibrahim Ethem Kirez
Specialist Doctor
Istanbul Saglik Bilimleri University