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临床试验/NCT05581186
NCT05581186已完成不适用

Efficacy of Pulse Electromagnetic Field Therapy (PEMF) in Patients With Nonspecific Chronic Neck Pain: A Randomized Controlled Study

Afyonkarahisar Health Sciences University2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2022年8月1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
75
试验地点
2
主要终点
Change from baseline visual analog scale (VAS) neck and arm pain at 3rd and 6th week

研究概览

简要总结

This investigation aims to investigate the effectiveness of Pulse Electromagnetic Field Therapy (PEMF) on neck pain, cervical range of motion, pressure pain threshold and quality of life in patients with nonspecific chronic neck pain compared to cervical therapeutic exercises.

详细描述

Neck pain is a common musculoskeletal complaint in society. It is the most common musculoskeletal problem after low back pain. It may regress spontaneously within a few weeks or may become chronic, as in 30% of patients. When it becomes chronic, it can negatively affect the daily life activities of individuals and lead to functional limitations and inadequacies.

Various approaches exist for neck pain in clinical practice. Among them; education of patients on neck pain, ergonomic arrangements, analgesics, non-steroidal anti-inflammatory drugs, muscle relaxants, exercise, physical therapy agents such as transcutaneous electrical stimulation (TENS), superficial and deep heaters, Pulse Electromagnetic Field Therapy (PEMT) , manipulation, mobilization methods, nerve blockages and surgical intervention.

Magnetotherapy is a treatment method based on magnetic field interaction. As a result of pulsed or alternating electromagnetic fields, an electrical current occurs in the tissues. Pulse magnetotherapy has three physical mechanisms known to be effective in living tissue: Magnetic induction, magneto-mechanical effects, and electronic interactions. Effects of magnetic field application are vasodilation, analgesic effect, anti-inflammatory effect, acceleration of healing, antiedematous effect. Magnetotherapy increases the oxygen release of erythrocytes and provides oxygenation of the tissues. This causes a decrease in toxins in the damaged area, an increase in vital nutrients and endorphins. With this physiological change, magnetic energy decreases the pain receptor sensitivity that sends a message to the brain. With this treatment method, pain reduction is achieved, while joint mobility increases. This investigation was designed prospective sham controlled randomized study. Participants were randomized into 3 groups: PEMT + therapeutic exercise, sham PEMT + therapeutic exercise, and only therapeutic exercise. As evaluation parameters, cervical range of motion, Visual Pain Scale (VAS) Neck, Visual Pain Scale (VAS) Neck, SF (Short form) -36 Quality of Life Scale, pressure pain threshold measurement with an algometer, patient global assessment, and physician global assessment will be evaluated with.It was planned that the evaluations were made and recorded by a blinded physician to the groups at the beginning of the treatment, at the end of the treatment and at the 6th week controls.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Neck pain for at least 3 months in the 20-55 age range
  • Diagnosed with nonspecific chronic neck pain by examination, history and imaging methods

排除标准

  • Inflammatory rheumatologic diseases
  • Having a cardiac pacemaker
  • Previous surgery related to the cervical spine
  • Having bleeding diathesis
  • Having a body implant with an electronic or battery system
  • Neck pain due to neurological and vascular diseases
  • Having neurological diseases
  • Having received physical therapy and rehabilitation for the cervical area in the last 6 months
  • Acute infections

结局指标

主要结局

Change from baseline visual analog scale (VAS) neck and arm pain at 3rd and 6th week

时间窗: up to 6th week

Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity.

次要结局

  • Change from baseline quality of life (short form 36 (SF-36)) at 3rd and 6th weeks(up to 6th week)
  • Change from baseline In the doctor's global evaluation at 3rd and 6th weeks(up to 6th week)
  • Change from baseline range of motion of cervical spine measurements with goniometer at 3rd and 6th weeks(up to 6th week)
  • Change from baseline Neck Dısabılıty Index (NDI) at 3rd and 6th weeks(up to 6th week)
  • Change from baseline In the global evaluation of the patient at 3rd and 6th weeks(up to 6th week)
  • Change from baseline Pressure pain threshold measurement with an algometer at 3rd and 6th weeks(up to 6th week)

研究者

发起方
Afyonkarahisar Health Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nur Doğanlar

Medical research assistant

Afyonkarahisar Health Sciences University

研究点 (2)

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