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临床试验/NCT04914637
NCT04914637已完成不适用

The Effect of Dry Needling on the Treatment Outcomes of Interlaminar Epidural Steroid Injection in Patients With Chronic Neck Pain Due to Cervical Disc Herniation.

Marmara University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2021年6月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
1
主要终点
Change of pain severity from baseline to each checkpoints

研究概览

简要总结

Chronic neck pain is among the most frequently seen chronic painful conditions. As an important cause of disability, chronic neck pain is a musculoskeletal disorder that negatively affects quality of life. Cervical disc herniation is one of the leading causes of chronic neck pain and conservative methods such as exercise and pain medications are used first in the treatment. In patients unresponsive to conservative treatment, epidural steroid injection is successfully and frequently used treatment option. Epidural steroid injection in the cervical region can be applied with two approaches: interlaminar or transforaminal.

Myofascial trigger point characterized by intramuscular taut band and hypersensitive spots is a condition in which central and peripheral sensitization play a role in the pathophysiology. There are underlying myofascial trigger points in many etiologies that cause chronic neck pain. Trigger points can increase the severity of pain and in some cases they can be the main factor in the etiology of pain. Therefore, the presence of myofascial trigger points should be investigated, even if another cause is detected in chronic neck pain. Dry needling is an easily applicable and effective treatment option in myofascial trigger point.

Although it is well known that myofascial trigger points frequently accompany cervical disc herniation, their effect on treatment outcomes has not been investigated. In this study, we aimed to investigate the effect of dry needling for trigger points on the treatment results of interlaminar epidural steroid injection in patients diagnosed with cervical disc herniation.

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
Single (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

入选标准

  • Between the ages of 18-65
  • Chronic neck pain due to cervical disc herniation for at least 3 months and being unresponsive to conservative treatment
  • Presence of at least one active myofascial trigger point on physical examination of cervical paraspinal muscles, scapulothoracic muscles and extremity muscles.

排除标准

  • Previous surgical/interventional procedure for the cervical region
  • Previous application of dry needling/acupuncture to any part of the body
  • Presence of other musculoskeletal disorders (such as lateral epicondylitis, tendinitis, entrapment neuropathy) that may cause diagnostic confusion in terms of pain pattern and localization
  • Signs of trauma, fracture, malignancy, or active infection
  • Rheumatological (RA, AS, etc.), endocrinological (such as osteoporosis, Paget's disease) or another systemic disease that may change the anatomical or physiological structure of the relevant regions
  • Presence of coagulopathy
  • History of whiplash injury, cervical spinal stenosis, cervical spondylosis
  • Have a diagnosis of fibromyalgia
  • Being pregnant and breastfeeding
  • Presence of mental deterioration or psychiatric/neurological disease that can affect flow of the study.

结局指标

主要结局

Change of pain severity from baseline to each checkpoints

时间窗: from pre-interventional time to post-interventional 1st hour, 3rd week, 3rd month

Pain severity will be assessed with Numeric Rating Scale (NRS). The patient scores his/her pain between 0-10. Higher score indicates more severe pain

Change of the number of active trigger points from baseline to each checkpoints

时间窗: from pre-interventional time to post-interventional 3rd week, 3rd month

The number of active trigger points will be determined by clinical examination. The trigger point will be defined as "active" if it causes spontaneous pain or pain occured during the examination is familiar to the patient.

次要结局

  • Change of the number of the patients with neuropathic pain from baseline to each checkpoints(from pre-interventional time to post-interventional 3rd week, 3rd month)
  • Change of depression severity from baseline to each checkpoints(from pre-interventional time to post-interventional 3rd week, 3rd month)
  • Change of the measurement of quality of life from baseline to each checkpoints(from pre-interventional time to post-interventional 3rd week, 3rd month)
  • Change of the measurement of sleep quality from baseline to each checkpoints(from pre-interventional time to post-interventional 3rd week, 3rd month)
  • Change of the pain sensitivity of active trigger points from baseline to each checkpoints(from pre-interventional time to post-interventional 3rd week, 3rd month)
  • Change of the measurement of disability related with chronic neck pain from baseline to each checkpoints(from pre-interventional time to post-interventional 3rd week, 3rd month)
  • Change of the number of the patients with central sensitization from baseline to each checkpoints(from pre-interventional time to post-interventional 3rd week, 3rd month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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