Clinical Effectiveness of High-Intensity Laser Therapy in Patients With Cervical Radiculopathy: A Randomized Study of Double Blınd With Sham Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change from baseline visual analog scale (VAS) neck and arm pain at 4th and 12th week
研究概览
简要总结
This investigation aims to investigate the effect of high intensity laser therapy on radicular symptoms, neuropathic pain, cervical range of motion and quality of life in patients with cervical radiculopathy compared to cervical therapeutic exercises.
详细描述
Most cases of cervical radiculopathy are due to cervical spondylosis or disc herniation. As the age progresses, disintegration of the disc causes a decrease in disc height and foraminal narrowing. The decreased disc height then results in hypertrophy due to vertebral loading in the intervertebral joints of Luschka. This leads to foraminal stenosis and cervical radiculopathy.If cervical radiculopathy is due to disc herniation, its mechanism is explained by the impact of the nerve root with the disc material and causing nerve damage by both mechanical and chemical effects.Non-operative treatment of cervical radiculopathy consists of a number of different modalities including immobilization, physical therapy, traction, manipulation,drug therapy, cervical steroid injection and laser therapy.The physiological effects of high intensity laser therapy(HILT) reduce the release of histamine and bradykinin from inflammatory tissue and increase the pain threshold. In addition, laser light reduces the secretion of substance P from peripheral nociceptors, thereby reducing the perception of pain and preventing the development of hyperalgesia. The laser analgesic effect is due to the increased secretion of endogenous opioids such as β-endorphins, where pain is centrally inhibited.
This investigation was designed double-blind prospective sham controlled randomized study. Participants were randomized into 3 groups: HILT + therapeutic exercise, sham HILT + therapeutic exercise, and only therapeutic exercise.
As evaluation parameters, cervical range of motion, Visual Pain Scale (VAS) Neck, Visual Pain Scale (VAS) Arm, SF (Short form) -36 Quality of Life Scale, Pain Detect Pain questionnaire, Cervical Radiculopathy Impact Scale ) 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 3rd month controls.
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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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible patients aged 20-65 years old with pain in the cervical spine and arm pain with or without neck pain lasting for at least one month. Patients were included in the study
- •radicular clinical symptoms
- •cervical disc herniation and degenerative changes diagnosed with cervical MR
- •radiculopathy findings on Electromyography (EMG) and Nerve Conduction Studies
排除标准
- •Inflammatory rheumatologic diseases
- •Structural deformity
- •Previous surgery related to the cervical spine
- •Cervical spinal stenosis
- •Lokal corticosteroid injections
- •Medications for neuropathic pain such as pregabalin or gabapentin
- •Carpal tunnel syndrome, cubital tunnel syndrome
- •Shoulder pathology
结局指标
主要结局
Change from baseline visual analog scale (VAS) neck and arm pain at 4th and 12th week
时间窗: up to 12th 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 Neck Dısabılıty Index (NDI) at 4th and 12th weeks(up to 12th week)
- Change from baseline quality of life (short form 36 (SF-36)) at 4th and 12th weeks(up to 12th week)
- Change from baseline range of motion of cervical spine measurements with goniometer at 4th and 12th weeks(up to 12th week)
- Change from baseline Pain detect questionnaire (PD-Q) at 4th and 12th weeks(up to 12th week)
- Change from baseline Cervical Radiculopathy Impact Scale(CRIS) at 4th and 12th weeks(up to 12th week)
研究者
Songül İnce
Research Assistant Doctor
Afyonkarahisar Health Sciences University