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临床试验/NCT04455048
NCT04455048已完成不适用

The Effectiveness of Manipulation Treatment in Acute Cervical Region Pain

Abant Izzet Baysal University2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2019年2月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
2
主要终点
Pain pressure threshold

研究概览

简要总结

Neck pain is the second most common musculoskeletal pain after lumbar pain. Prevalence is 27.2% female and 17.4% in male population (1, 2). Approximately 1/3 of acute onset neck aches become chronic. It causes increasing the cost of treatment and also the loss of labor (3, 4).

详细描述

Acute neck pain is often caused by mechanical causes and can be classified as rheumatic diseases, infectious and tumoral pathologies, metabolic bone diseases such as osteoporosis and osteomalacia, pain reflected the cervical region. A-V malformation and syringomyelia are the causes of chronic cervical pain (5). Mechanical neck pain is a non-radicular pain caused by local musculoskeletal structures and is characterized by a spasm of the cervical muscles. (6, 7). Posture, emotional stress, cold and fatigue are etiologic causes, and pain is also reflected in the cervical, occipital and scapular regions depending on the severity of muscle spasm and the presence of trigger point in myofascial pain syndrome (9, 10). Many authors have suggested that facet joints are associated with mechanical dysfunction as a common cause of cervical pain (8-10).

The pain in the head and neck region affects the quality of life, cognitive and functional status of the person. The most important difficulty and failure in the treatment of such pain arise from the inability to diagnose the disease correctly. Good anatomical and biomechanical properties of the region, comprehensive anamnesis, physical examination under static and dynamic conditions, laboratory and radiological examinations are the most important milestones of diagnosis (12). In most cases, medical treatment and physical therapy modalities (superficial and deep heat, electrotherapy, laser, traction, massage, spa) are sufficient for pain relief and recovery of function, but interventional procedures and surgical procedures are needed for the fewer patient. Recently, spinal mobilization and manipulation techniques can be used to relieve pain and restore function in the early stages. Although it is a safe method, in order to prevent the rare complications it is necessary to determine the indications of treatment correctly, to exclude contiguous cases and to apply the manipulation by experts (12).

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

The manipulation group will receive a single session thrust manipulation and the control group will receive a sham manipulation. Outcome assessment will be performed by another investigator.

入排标准

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

入选标准

  • •Clinical diagnosis Nonspecific neck pain (NSNP)
  • •Symptoms should last longer than 12 weeks

排除标准

  • •Any known cause such as radiculopathy or neurological diseases,
  • •History of neck surgery,
  • •History of vertebral fracture,
  • •Osteoporosis,
  • •Tumor or a mass in the vertebral column,
  • •Any spinal thrust manipulation contraindication,
  • •Medication usage such as antiinflammatory or analgesic which might effect outcome assessments,
  • •History of spinal manipulation

研究组 & 干预措施

Control Group

Sham Comparator

A sham manipulation without a high-speed low-amplitude thrust technique in the cervicothoracic transition region will be applied.

干预措施: Cervicothoracic thrust manipulation sham (Other)

Intervention Group

Experimental

A single-session manipulation with a high-speed low-amplitude thrust technique in the cervicothoracic transition region will be applied each week for two weeks.

干预措施: Cervicothoracic thrust manipulation (Other)

结局指标

主要结局

Pain pressure threshold

时间窗: two weeks

Pain pressure threshold (PPT). was assessed with an algometer (JTECH Medical, Salt Lake City, UT) with 1 cm2 rubber tip was used to measure the pain pressure threshold. Algometer perpendicularly placed over spinous process of T1 on prone position and pressure progressively increased 1 kg/s until patients verbally reported pain under the tip of algometer or referring pain. Measurement repeated three times and average score recorded.

次要结局

  • Cervical range of motion(two weeks)
  • Visual analog scale(two weeks)
  • Global Perceived Effect Scale(two weeks)
  • Neck Disability Index(two weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ramazan KURUL

Assistant Professor

Abant Izzet Baysal University

研究点 (2)

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