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临床试验/NCT03737916
NCT03737916已完成不适用

To Evaluate the Effect of Perineural Dextrose Injection in Patients With Ulnar Neuropathy at the Elbow and to Compare the Control Group

Ankara Education and Research Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年11月18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
60
试验地点
2
主要终点
Change from baseline of pain on 2nd week, 1st and 3rd months after treatment: VAS

研究概览

简要总结

Ulnar neuropathy at the elbow (UNE) is the second most common neuropathy and occurs after recurrent or elongated elbow flexion. Diagnosis of UNE depends on clinical symptoms, physical examination, and electrophysiological findings. Imaging methods such as ultrasonography (USG) and magnetic resonance imaging show cross-sectional area and echogenicity of ulnar nerve and give information about to surrounding structures around the ulnar nerve. In mild and moderate cases, conservative treatments are administered up to 6 months, who do not benefit from conservative treatment are referred to surgery. There are not many options for conservative treatment. Activity modification, nerve gliding exercises and night splints are conservative treatment methods. Steroid injection is no longer recommended. Perineural dextrose injection is applied in tendinopathies and entrapment neuropathies (especially carpal tunnel syndrome). In the literature, there is no study showing effect of perineural dextrose injection in patients with UNE. The investigators design a randomized, double-blind, controlled trail to evaluate the effect after ultrasound-guided perineural injection with 5% dextrose in patients with UNE.

详细描述

After obtaining written informed consent, patients of clinically diagnosed with UNE were randomized into intervention and control group. Participants in intervention group received one-session ultrasound-guided perineural injection with 5% dextrose and control group received one-session ultrasound-guided perineural injection with normal saline. No additional treatment after injection through the study period. The primary outcome is visual analog scale (VAS) and secondary outcomes include Quick-DASH (Disabilities of Arm, Shoulder and Hand), cross-sectional area (CSA) of the ulnar nerve, motor nerve conduction velocity and distal latency of the ulnar nerve. The evaluation was performed pretreatment as well as on the 2nd week, 1st and 3rd month after the treatment.

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

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18-65 year-old.
  • Neuropathic pain on the ulnar nerve distribution area for at least 1 months
  • Diagnosis was confirmed using an electrophysiological studies and ultrasonography

排除标准

  • History of trauma to the upper extremity
  • Central or peripheral neurologic disease
  • Electromyography (EMG)-proven carpal tunnel syndrome, radiculopathy or any other neuropathy
  • Pregnancy or any systemic disease that might cause swelling on nerves (e.g., diabetes -mellitus, renal failure, and thyroid disease)
  • USG-detected bifid or trifid median nerve, persistent median artery, or space-occupying lesions

结局指标

主要结局

Change from baseline of pain on 2nd week, 1st and 3rd months after treatment: VAS

时间窗: Time Frame: Pre-treatment, 2nd week, 1st and 3rd months after treatment

Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment. Recorded on a visual analogue scale (VAS), scores range from 0 to 100 mm, with higher scores indicating worse pain.

次要结局

  • Change from baseline in activity and functional status on 2nd week, 1st and 3rd months after treatment.(Pre-treatment, 2nd week, 1st and 3rd months after treatment)
  • Change from baseline in cross-sectional area of the ulnar nerve on 1st and 3th months after treatment.(Pre-treatment, 2nd week, 1st and 3rd months after treatment treatment)
  • Change from baseline in motor nerve conduction velocity of the ulnar nerve(Pre-treatment, 1st and 3rd months after treatment treatment)

研究者

发起方
Ankara Education and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Basak Mansiz-Kaplan

Department of Physical Medicine and Rehabilitation (the principal investigator)

Ankara Education and Research Hospital

研究点 (2)

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