跳至主要内容
临床试验/NCT06406231
NCT06406231招募中不适用

Magnetic Field Therapy Versus Transcutaneous Electrical Nerve-stimulation in Knee Osteoarthritis: a Head-to-head Trial

University Tunis El Manar2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
2
主要终点
response to physical therapy

研究概览

简要总结

The effectiveness of PEMF in improving physical function among Osteoarthritic (OA) patients remains a topic of debate, leading to the American College of Rheumatology not yet endorsing its use in OA treatment. Therefore, it's essential to investigate PEMF therapy's efficacy in alleviating joint pain, stiffness, and enhancing physical function in knee OA patients Our study objectives were to evaluate the effectiveness and safety of PEMF therapy and to compare its efficacy with TENS in knee OA management.

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
Double (Participant, Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • We included patients who had knee pain due to knee OA diagnosed according to the American College of Rheumatology including:
  • Knee pain AND presence of at least three of the following 6 criteria:
  • Age > 50 years
  • Morning stiffness < 30 minutes
  • Crepitus during movement
  • Periarticular bone pain
  • Periarticular bone hypertrophy
  • Absence of increased local warmth.

排除标准

  • For both groups, we did not include:
  • Patients with a pacemaker, implantable defibrillator, cochlear implant, or any metal implant contraindicating MRI (knee prosthesis, hip prosthesis, etc.).
  • Pregnant women
  • Patients with an active infection
  • Profound hypoesthesia or thermoalgic sensitivity disorder
  • Poorly vascularized areas: arteritis, phlebitis, ischemia
  • Patients on anti-vitamin K treatment or with a coagulation disorder. Patients with long-term corticosteroid therapy or having a total knee replacement, those who have received therapies for knee osteoarthritis including intra-articular corticosteroid injection or viscosupplementation in the last 4 months, and Patients with knee pain of non-osteoarthritic origin were also not included in the study.

结局指标

主要结局

response to physical therapy

时间窗: one week before the beginning and 3 weeks after the finishing of the rehabilitation program

a 20 percent decrease in the total score of WOMAC pain

次要结局

  • assessing patients satisfaction(one week before the beginning and 3 weeks after the finishing of the rehabilitation program)
  • stiffness and function improvement(one week before the beginning and 3 weeks after the finishing of the rehabilitation program)
  • reduction of pain(one week before the beginning and 3 weeks after the finishing of the rehabilitation program)
  • Consumption of paracetamol(one week before the beginning and 3 weeks after the finishing of the rehabilitation program)
  • assessing safety(one week before the beginning and 3 weeks after the finishing of the rehabilitation program)

研究者

发起方
University Tunis El Manar
申办方类型
Other
责任方
Principal Investigator
主要研究者

RAZGALLAH Emna

medical resident

University Tunis El Manar

研究点 (2)

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