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临床试验/NCT06086210
NCT06086210已完成不适用

Evaluation of the Efficacy of Low Level Laser Therapy in Ulnar Neuropathy at the Elbow in Terms of Symptoms, Clinical and Electrophysiological: A Randomized, Prospective, Double-blind Clinical Trial

Gulsah Celik2 个研究点 分布在 2 个国家目标入组 68 人开始时间: 2022年10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
68
试验地点
2
主要终点
Visual Analog Scale (VAS)

研究概览

简要总结

The purpose of this study is, to demonstrate the effectiveness of low-level laser therapy on symptoms, clinical and electrophysiological parameters in elbow ulnar neuropathy.

详细描述

Ulnar neuropathy of the elbow is the second most common entrapment neuropathy of the upper extremity. The ulnar nerve is prone to entrapment due to its anatomical location in the elbow. The most important cause of entrapment occurs as a result of frequent chronic mechanical compression or stretching. Repetitive flexion-extension movement of the elbow increases the pressure in both the cubital tunnel and other potential entrapment sites, causing tension in the ulnar nerve and increased intraneural pressure.

Ulnar neuropathy of the elbow, a detailed history and a comprehensive physical examination are the essential first steps in making the correct diagnosis. In case of doubt, electrophysiological studies, in particular, play an important role in diagnosis by determining both the location of nerve compression and the severity of the disease. There are conservative and surgical methods for the treatment of ulnar neuropathy in the elbow. In most patients, especially in mild and moderate entrapments, conservative treatment is preferred instead of surgery as initial treatment.

Low-level laser therapy, one of the physical therapy modalities, creates photochemical reactions and biostimulation in the cells, interstitial tissue, vascular structure and immune system. Its anti-inflammatory effect is through inhibition of Cyclooxygenase-2 enzyme and a decrease in Prostaglandin E2 levels, and its analgesic effect is by inhibiting nociceptive pathways in peripheral nerves, thus reducing pain. It has been shown to increase nerve regeneration and nerve conduction, reduce the effects of nerve compression, and may stimulate nerve healing thanks to its biophysical effect.

There is no sham-controlled study showing the effectiveness of low-level laser therapy in elbow ulnar neuropathy, the second most common entrapment neuropathy. The study was planned to investigate the effectiveness of low-level laser treatment on symptoms, clinical and electrophysiological parameters in elbow ulnar neuropathy.

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, Outcomes Assessor)

盲法说明

Since the light coming from the probe was visible in the laser applications used in both groups, the patients were not able to learn which group they were in, meaning they were blinded. All outcome measures were evaluated by another researcher who did not know which group the patients were in, thus ensuring that the study was double-blind.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Ulnar neuropathy at the elbow evidenced by electrophysiological evaluation
  • Symptoms onset with more than 1 months

排除标准

  • Presence of thenar, hypothenar or intrinsic muscle atrophy,
  • Diabetes mellitus
  • Hypothyroidism
  • Receiving an electrophysiological diagnosis of carpal tunnel syndrome, cervical radiculopathy, brachial plexopathy, thoracic outlet syndrome
  • Vascular disease
  • Ulnar nerve injury or trauma,
  • Malignancy,
  • Having received treatment for ulnar neuropathy in the elbow within the last 3 months,
  • Using nonsteroidal anti-inflammatory drugs (NSAI) regularly

结局指标

主要结局

Visual Analog Scale (VAS)

时间窗: Baseline, Days 15 and Months 3

The patient's symptoms were filled in, with the VAS score increasing from 0 to 10. The end of a 10 cm line with 0 cm indicating no complaints (best) and the end with 10 cm indicating very severe complaints (worst).

次要结局

  • Hand Grip Strength(Baseline, Days 15 and Months 3)
  • Provocative Tests(Baseline, Days 15 and Months 3)
  • QuickDASH score(Baseline, Days 15 and Months 3)
  • Electrophysiological Studies(Baseline, Days 15 and Months 3)

研究者

发起方
Gulsah Celik
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Gulsah Celik

Principal Investigator

Antalya Training and Research Hospital

研究点 (2)

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