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临床试验/NCT06281444
NCT06281444已完成不适用

Effectiveness of the Effect of Radial Extracorporeal Shock Wave Therapy in Addition to Exercise on Pain, Functionality and Walking Distance in Patients With Knee Osteoarthritis: A Randomized Controlled Trial

Ankara University2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
2
主要终点
Change in pain [by using the Visual Analogue Scale(VAS)]

研究概览

简要总结

Osteoarthritis (OA) is a degenerative joint disease characterized by unsuccessful repair of joint damage resulting from stresses in any of the synovial joint tissues. Symptoms include pain (initially only after movement), joint stiffness, limitation of joint movement, feeling of insecurity in the joint, and difficulty walking. The diagnosis of knee osteoarthritis can be easily made with a detailed history and a comprehensive physical examination. Radiographic examinations are used to support clinical findings and exclude other possible pathologies. The main purpose of treating knee osteoarthritis is to reduce pain and make daily life easier. Since there is no standard treatment method, the patient's treatment must be individualized by taking into account age, comorbidity, severity of the clinical picture, patient preferences and cost of treatment. Conservative treatment includes pharmacological and non-pharmacological treatment, and the optimal treatment should be applied as a combination of these two methods. Patient education, lifestyle modification, exercise, different physical therapy modalities (TENS, Interferential current, ESWT...), acupuncture are some non-pharmacological methods.

Extracorporeal shock wave therapy (ESWT), which is considered within the scope of conservative treatment, started in the seventies with the practice of breaking ureteric stones and has become one of the physical therapy modalities used in the treatment of various musculoskeletal diseases. Considering the historical development of ESWT, it has started to be used as a therapeutic modality in the treatment of knee osteoarthritis in recent years. The process, which started with animal experiments, continued with human studies, and evidence is presented that ESWT reduces knee pain and contributes to functionality. It is noteworthy that there are few studies and their short follow-up periods. In the light of these studies, it was planned to investigate the effectiveness of ESWT treatment, which will be applied together with exercise, on pain, functionality and walking distance in individuals diagnosed with knee osteoarthritis, in comparison with the control group receiving sham ESWT.

详细描述

The study was planned as a randomized controlled trial. Eligible patients who meet the inclusion criteria, will be invited to the study.

Patients who accepted to participate in the study by meeting the criteria will be randomly divided into two groups as the first group treatment ESWT + exercise, the second group sham ESWT + exercise. Computer-aided software will be used to assign patients to treatment groups.

The following evaluations will be made: Visual Analog Scale (VAS), Patient Global Assessment (PGA), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and 6-minute walk test (6MWT).

VAS is widely used in the assessment of pain. In the present study, pain was assessed in three conditions: at rest, during movement, and at night.

PGA is an instrument used in clinical settings to capture the patient's subjective appraisal of overall health and disease-related well-being, serving as a concise indicator of disease activity.

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)

盲法说明

Patients who meet the study conditions and agree to participate in this study will not know whether they are in the first group or the second group.

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being over 50-85 years old.
  • Diagnosis of knee osteoarthritis according to ACR clinical/radiological diagnostic criteria
  • Stage 2 and above according to Kellgren Lawrence (K-L)
  • Completion of Informed Signed Consent Form

排除标准

  • Gait disorders due to orthopedic or neuromuscular disease
  • Participation in a structured physical rehabilitation program in the last 12 months before the study
  • Those who have had an intra-articular injection of the knee in the last 6 months
  • History of lower extremity surgery
  • Those with mechanical instability in the knee, a history of infection, malignancy
  • Inflammatory rheumatic diseases (rheumatoid arthritis, spondyloarthritis etc.)
  • A medical diagnosis or self-reported cognitive impairment
  • Presence of progressive cancer AND/OR other diseases that impair general condition
  • Situations where ESWT application is contraindicated
  • Having previously received ESWT treatment
  • Patients with hip and/or ankle pathology

研究组 & 干预措施

ESWT group

Active Comparator

The participants in this group will be applied with ESWT plus a home-based exercise program.

干预措施: ESWT (Device)

Sham-ESWT group

Sham Comparator

The participants in this group will be applied with sham-ESWT plus a home-based exercise program.

干预措施: Sham-ESWT (Device)

结局指标

主要结局

Change in pain [by using the Visual Analogue Scale(VAS)]

时间窗: Up to 24 weeks

It was defined as the change in pain (VAS) felt after 4 sessions of ESWT treatment from baseline. Visual Analog Scale (VAS): Vas is widely used in pain assessment. The numbers 0 and 10 are written at both ends of a 10 cm line. 0 = I have no pain 10 = means I have unbearable pain. The pain level increases from 0 to 10. The patient is asked to indicate which point on this chart is most appropriate for his/her situation. The location marked by the patient will be evaluated by measuring its distance from point 0.

次要结局

  • Change from baseline in walking distance(Up to 24 weeks)
  • Change from baseline in functionality and walking distance(Up to 24 weeks)
  • Change from baseline in functionality and walking distance(Up to 24 weeks)
  • Change from baseline in walking distance(Up to 24 weeks)
  • Patient Global Assesment (PGA) [by using the VAS](Up to 24 weeks)

研究者

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

Birkan Sonel Tur

Clinical Professor (Physical Medicine and Rehabilitation)

Ankara University

研究点 (2)

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