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临床试验/NCT06067659
NCT06067659已完成不适用

Comparison Of The Treatment Effects Of Extracorporeal Shockwave Therapy And Kinesiological Banding In Patients With Calcaneal Spur

University of Beykent2 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2023年6月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Visual Analog Scale

研究概览

简要总结

Calcaneal spur (heel spur) is one of the most common disorders associated with foot pain. Patients may complain of pain at every step during the day, so it is important to find the most effective treatment method for patients. The aim of this study is to compare the therapeutic efficacy of extracorporeal shock wave therapy (ESWT) and kinesiology taping (KB) in patients with calcaneal spurs.

Thirty patients with calcaneal spurs will be included in the study. The gender, age, body weight, height, body mass index, and affected side of the patients will be recorded. Patients will be randomly divided into three treatment groups: ESWT to the first group, KB therapy to the second group, and combined ESWT+KB to the third group. Each group will be treated for five sessions, once a week for five weeks. ESWT 15Hz frequency will be applied as 2.5 Barr energy and 2000 Shock/session. It will be applied with the KB I and fan method and the tape will not be removed for three days after the application. In the pre- and post-treatment evaluations of the patients, heel sensitivity and sensory perception will be evaluated with the Foot structure Foot Posture Index (API). Visual Analog Scale (VAS), Quality of Life Short Form-36 (SF-36), Foot Function Index (AFI) and Windlass Test will be used.

详细描述

One of the most common pathologies that causes foot pain, negatively affects the individual's walking and reduces the quality of life is calcaneal spur (heel spur). Calcaneal spurs are fibro-cartilaginous protrusions varying in size that form around the calcaneal bone, the strongest, most important and rearmost bone in the foot.

Treatment aims to reduce pain, reduce inflation, and shrink and eliminate the spur. Conservative treatment includes exercises, massage, ultrasound, phonophoresis, laser, short wave diathermy, cryotherapy and extracorporeal shock wave therapy (ESWT) as physiotherapy applications.

ESWT are pressure waves delivered to the body to stimulate soft tissue growth through local hyperemia, neovascularization, reduction of calcification, inhibition of pain receptors and denervation to provide pain relief and healing of chronic processes. ESWT is also used effectively in the treatment of calcaneal spur.

The aim of this study is to observe the superiority, if any, of ESWT and KB in the treatment of each other or to show how effective the combined application of the two is in the treatment of calcaneal spur.

This study will be a single-blind, randomized controlled trial to compare the effectiveness of BP and ESWT in patients with calcaneal spurs. All procedures used will be carried out in accordance with the ethical rules of the Declaration of Helsinki and were approved by the Amasya University Clinical Research Ethics Committee (E-30640013-050.01.04-126508). The study will be carried out on patients who applied to the Physical Therapy and Rehabilitation Polyclinic of a hospital between 10.10.2023 and 10.12.2023 with the complaint of heel pain and diagnosed with calcaneal spur.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Inclusion criteria for the study were diagnosis of calcaneal spur by a physician, being in the age range of 30-70 years, patient complaining of pain in the heel region, appearance of calcaneal protrusion in the radiographic image, no other treatment or medication (NSAI, steroids, other drugs, etc.) analgesics) and the patient volunteered to participate in the study. Exclusion criteria were those who received injection therapy to the foot area (corticosteroids or corticosteroids/anesthetics), those with a history of rheumatic disease, coagulopathy, thrombophlebitis, neoplasia, systemic inflammatory disease, and outpatient surgery in the last 3 months. No other treatment or medication (NSAI, steroids, other analgesics) will be used during the study period.

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of calcaneal spur by the physician
  • Be between 30-70 years old
  • The patient complains of pain in the heel region
  • Appearance of the calcaneal protrusion on the radiographic image
  • Not taking any other treatment or medication (NSAI, steroids, other analgesics) until 4 weeks before the start of the study.
  • The patient's willingness to participate in the study.

排除标准

  • Those who received injection therapy to the foot area in the last 3 months (corticosteroids or corticosteroids/anesthetics),
  • Those with rheumatic disease, coagulopathy, thrombophlebitis, neoplasia history, systemic inflammatory disease
  • Those with a history of outpatient surgery

结局指标

主要结局

Visual Analog Scale

时间窗: Day 1 and 5 weeks later

It is a subjective evaluation method that converts some values that cannot be measured numerically into numbers. Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line (no pain at all, I have excruciating pain) and the patient will be asked to indicate where on this line their situation is appropriate by drawing a line or pointing or pointing.

Foot Function Index

时间窗: Day 1 and 5 weeks later

It is a self-filled form developed to measure the effects of foot pathologies on pain, disability and activity limitation. Foot function index; It consists of 23 items with 3 subgroups as pain, disability and activity limitation. A higher score indicates more pain, disability, and activity limitation.

次要结局

  • Sociodemographic information(Day 1 and 5 weeks later)
  • Quality of Life Short Form-36(Day 1 and 5 weeks later)
  • Windlass Test(Day 1 and 5 weeks later)

研究者

发起方
University of Beykent
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasemin Şahbaz

Lecturer

University of Beykent

研究点 (2)

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