Effectiveness of Pulse Electromagnetic Field Therapy (PEMF) on Pain, Functional Status, and Quality of Life in Patients With Chronic Radicular Pain Due to Lumbar Disc Herniation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- 10 cm Pain Visual Analogue Scale (VAS)
研究概览
简要总结
The aim of this study is to investigate the effectiveness of pulse magnetic field therapy on pain, functional status, and quality of life in patients with chronic radicular pain due to lumbar disc herniation.
详细描述
Pulsed Electromagnetic Field Therapy (PEMF) is a non-invasive, painless treatment for various injuries, bone related conditions and pains. However, further studies on PEMF effects on low back and radicular pain is needed due to lack of studies in this area.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65
- •Unilateral radicular pain for at least 3 months
- •Severity of radicular pain with Visual Analog Score of at least 4/10
- •Written informed consent
排除标准
- •Pregnancy or lactation
- •Cardiac pacemaker, or any metal implants or electronic devices anywhere in the body
- •History of surgery or algological procedure of the lumbar region
- •Physical therapy within the last year due to back pain
- •Previous PEMF treatment
- •Malignancy or suspicion
- •Polyneuropathy (diabetic or other)
- •Connective tissue disease
- •Presence of inflammatory joint pain
- •Fibromyalgia
- •Presence of open surface wound
- •Tuberculosis, mycosis, or viral disease
- •Presence of pain in another region of the body with higher severity than radicular back pain
- •Use of drugs other than paracetamol-derivative simple analgesics (Nonsteroidal Aanti inflammatuar, central effective, or narcotic analgesics), or less than three weeks since the discontinuation of these drugs
- •Advanced mood disorder
- •Radiographic evidence of Grade 2 spondylolisthesis, presence of spinal instability, and advanced degenerative spondylarthrosis
研究组 & 干预措施
Pulsed electromagnetic field (PEMF) treatment Group
Group received routine hot pack, Transcutaneous electrical nerve stimulation (TENS) and PEMF treatment.
干预措施: PEMF (Device)
Pulsed electromagnetic field (PEMF) treatment Group
Group received routine hot pack, Transcutaneous electrical nerve stimulation (TENS) and PEMF treatment.
干预措施: Hot pack (Device)
Pulsed electromagnetic field (PEMF) treatment Group
Group received routine hot pack, Transcutaneous electrical nerve stimulation (TENS) and PEMF treatment.
干预措施: TENS (Device)
Sham PEMF treatment Group
Group received routine hot pack, TENS and sham PEMF treatment.
干预措施: Hot pack (Device)
Sham PEMF treatment Group
Group received routine hot pack, TENS and sham PEMF treatment.
干预措施: TENS (Device)
Sham PEMF treatment Group
Group received routine hot pack, TENS and sham PEMF treatment.
干预措施: Sham PEMF (Device)
结局指标
主要结局
10 cm Pain Visual Analogue Scale (VAS)
时间窗: one month after treatment
The patient is asked to indicate their perceived pain intensity along a 10 cm horizontal line, where '0' represents 'no pain' and '10', 'unbearable pain'.
次要结局
- Nottingham Health Profile (NHP)(One month after treatment)
- Disability; Roland-Morris Disability Questionnaire (RMDQ)(One month after treatment)
研究者
Birkan Sonel Tur
Professor
Ankara University