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临床试验/NCT06381011
NCT06381011招募中不适用

Can Local Vibration be Used to Alleviate Symptoms of Cervical Radiculopathy?

Bitlis Eren University2 个研究点 分布在 2 个国家目标入组 34 人开始时间: 2024年8月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
34
试验地点
2
主要终点
Paresthesia

研究概览

简要总结

The aim of this study is to evaluate the effect of local vibration application on the upper extremity pain, paresthesia, neck pain, and limitations in cervical joint range of motion experienced by patients with cervical radiculopathy.

详细描述

At least 34 patients diagnosed with cervical radiculopathy who meet the inclusion and exclusion criteria will be included in the study. Subsequently, the patients will be randomly divided into two groups. Patients in the first group will receive placebo local vibration application in addition to conventional treatment, while patients in the second group will receive local vibration application in addition to conventional 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)

盲法说明

The evaluator and the researcher administering the local vibration application will be different. Patients will be blinded to their group assignment.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1. Between the ages of 18 and 70,
  • 2. Nerve root compression according to the magnetic resonance imaging,
  • 3. Unilateral or bilateral neck pain rated 3 or higher on the Numeric Pain Rating Scale, or neck pain with paresthesia or upper extremity pain rated 3 or higher on the Numeric Pain Rating Scale.

排除标准

  • 1. History of previous cervical or thoracic spinal surgery,
  • 2. Symptoms or signs of upper motor neuron disorder,
  • 3. Body mass index (BMI) higher than 35 kg/m2,
  • 4. Having received spinal injection in the last two weeks,
  • 5. Presence of local infection at the application site,
  • 6. Upper extremity nerve entrapment syndrome (such as carpal tunnel or cubital tunnel syndrome),
  • 7. Diagnosis of systemic inflammatory arthritis (such as rheumatoid arthritis, etc.),
  • 8. Having engaged in strenuous exercise in the last 24 hours,
  • 9. Poor or noncompliance to the treatment program

结局指标

主要结局

Paresthesia

时间窗: Change from baseline neck pain immediately and five days after the intervention

The effect of local vibration intervention on patients' paresthesia will be evaluated using the Patients' Global Impression of Improvement Scale. In this scale, patients will be asked to mark their perceived change in paresthesia using the following options: 'very much better,' 'much better,' 'a little better,' 'no change,' 'a little worse,' 'much worse,' and 'very much worse.'

Neck Pain

时间窗: Change from baseline neck pain immediately and five days after the intervention

The effect of local vibration intervention on patients' neck pain will be evaluated using the Patients' Global Impression of Improvement Scale. In this scale, patients will be asked to mark their perceived change in pain using the following options: 'very much better,' 'much better,' 'a little better,' 'no change,' 'a little worse,' 'much worse,' and 'very much worse.'

Upper Limb Pain

时间窗: Change from baseline neck pain immediately and five days after the intervention

The effect of local vibration intervention on patients' upper limb pain will be evaluated using the Patients' Global Impression of Improvement Scale. In this scale, patients will be asked to mark their perceived change in pain using the following options: 'very much better,' 'much better,' 'a little better,' 'no change,' 'a little worse,' 'much worse,' and 'very much worse.'

次要结局

  • Cervical Range of Motion(Change from baseline neck pain immediately and five days after the intervention)
  • The Change in the Pressure Pain Threshold of the Upper Trapezius(Change from baseline neck pain immediately and five days after the intervention)
  • The Change in the Viscoelastic Properties of the Upper Trapezius(Change from baseline neck pain immediately and five days after the intervention)

研究者

发起方
Bitlis Eren University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Omer Dursun

Asst. Prof.

Bitlis Eren University

研究点 (2)

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