跳至主要内容
临床试验/NCT06310122
NCT06310122尚未招募不适用

Effect of Extracorporeal Shockwave Therapy on Gait Parameters in Patients With Plantar Fascitis

Cairo University0 个研究点目标入组 52 人开始时间: 2024年3月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
52
主要终点
Stride length mean distance measured by (meter)

研究概览

简要总结

The purpose of this study is :

  • to determine the effect of extracorporeal shockwave on pain intensity in patients with plantar fasciitis.
  • to determine the effect of extracorporeal shockwave on foot function in patients with plantar fasciitis.
  • to determine the effect of extracorporeal shockwave on gait parameters in patients with plantar fasciitis

详细描述

Plantar fasciitis with an accompanying heel spur is very burdensome and difficult to treat disease. It most often arises as a result of degenerative changes of the proximal plantar fascia and the tissues surrounding the aponeurosis, occurring due to continuous irritation of the area and resulting micro-injuries. The main symptom of plantar fasciitis is pain in the heel area; this worsens over time, increasingly occurring upon loading and eventually, even at rest. Redness and swelling are also observed in the heel. The risk of the disease is increased by being overweight, working a job that requires long periods of standing, lifting heavy objects.

About 85% to 90% of patients do not need to undergo surgery, and 80% of patient do not experience pain relapse after conservative treatments. Minimally invasive treatments commonly used for treating PF are extracorporeal shockwave therapy (ESWT), corticosteroid (CS)injections, platelet-rich plasma (PRP) injections, botulinum toxin (BTX), acupuncture, dry needling and prolotherapy.

Conservative treatment options for PF include rest, weight loss, non-steroidal anti-inflammatory drugs, physical therapies (ultrasound therapy, low-energy, and laser therapy), plantar fascia and calf muscle strengthening and stretching exercises. If symptoms persist, second-option treatment is usually local corticosteroid injections. However, despite providing a good effect in terms of pain reduction, corticosteroids have proven to damage the fascial tissue, thus increasing the risk of further degeneration and eventual rupture. To avoid this complication, Extracorporeal shock wave therapy (ESWT) is a treatment recommendation for patients with chronic PF recalcitrant to other conservative treatment.

Extracorporeal shockwave therapy (ESWT) is a physical therapy that generates three-dimensional pressure pulses, lasting microseconds and reaching peek pressures of 35-120 MPa, and has effects depending on intensity, pulse cycle and shockwave (SW) modality. We have two modalities of SW therapy: focused shockwave (FSW) and radial shockwave (RSW). FSW is documented as a possible alternative to the surgical approach: it focuses on a small area (2 to 8 mm) and penetrates at a selected depth, having effects that depend on the energy delivered to the focal area; that is why it is important to know the energy flux density (EFD), which is considered the "dose" of SW administered.

RSW produces SW that are transmitted radially and do not have penetrating effects on tissue, acting superficially. They are frequently used in soft-tissue pathologies and, recently, also in plantar fasciitis. As this physical therapy is widely used for the treatment of plantar fasciitis. The mechanism of ESWT is not completely clear. However, it is speculated that ESWT may produce a reflexive analgesic effect by inducing excitability of the axon and destroying unmyelinated sensory fibers.

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)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • - 52 female patient with chronic planter fasciitis.
  • Patient,s age will be (18 - 40) , all of them are diagnosed with planter fasciitis will be recruited for the study.
  • BMI will be (18 - 40 kg/m2).
  • Unilateral chronic planter fasciitis.
  • Symptoms of pf pain lasted more than 3 months.
  • Diagnosis of painful heel syndrome by clinical examination, with the following positive clinical signs:
  • Pain in the morning or after sitting a long time.
  • Local pain where the fascia attaches to the heel.
  • Increasing pain with extended walking or standing for more than 15 minutes.
  • History of 6 months of unsuccessful conservative treatment.
  • Therapy free period of at least 4 weeks before referral.

排除标准

  • Patients will exclude from this study if their pain due to:
  • Bilateral plantar fasciitis.
  • Dysfunction of foot or ankle (for example, instability).
  • Arthrosis or arthritis of the foot.
  • Infections or tumors of the lower extremity.
  • Neurological abnormalities, nerve entrapment (for example, tarsal tunnel syndrome).
  • Vascular abnormality (for example, severe varicosities, chronic ischemia).
  • Operative treatment of the heel spur.
  • Hemorrhagic disorders and anticoagulant therapy.
  • Pregnancy.
  • Diabetes.
  • previous surgery.
  • Inflammation disease.
  • Rheumatoid arthritis

研究组 & 干预措施

Group (A) treatment group

Experimental

Group (A) will receive extracorporeal shockwave therapy and (Ultrasound, stretching and strengthening exercises)

干预措施: Extracorporeal shockwave therapy (Device)

Group (A) treatment group

Experimental

Group (A) will receive extracorporeal shockwave therapy and (Ultrasound, stretching and strengthening exercises)

干预措施: ultrasound (Device)

Group (B) traditional group

Experimental

Group (B) will receive (Ultrasound, stretching and strengthening exercises)

干预措施: ultrasound (Device)

结局指标

主要结局

Stride length mean distance measured by (meter)

时间窗: 4 weeks

stride length (one of gait parameters) that will be assessed by using Kinovea software.

stride time mean time measured by (second)

时间窗: 4 weeks

stride time (other gait parameters) that will be assessed by using kinovea software

speed mean distance/ time measured by (meter/second)

时间窗: 4 weeks

speed (other gait parameters) that will be assessed by using kinovea software.

cadence mean number of steps /times.

时间窗: 4 weeks

cadence (other gait parameters) that will be assessed by using kionvea software.

次要结局

  • pain intensity level.(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elham Mohammed Khairy Abd El Azeem El Naggar

Professor

Cairo University

相似试验