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临床试验/NCT04110119
NCT04110119已完成2 期

Effectiveness of Chiropractic Application in Patients With Acute Low Back Pain Presenting to the Emergency Department and Receiving Drug Treatment

Medipol University1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2018年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
98
试验地点
1
主要终点
Change in pain level

研究概览

简要总结

The aim of this project is to investigate the effectiveness of chiropractic application on patients who have undergone routine medication as a standard hospital treatment for mechanical low-back pain as described in the Clinical Practice Guidelines

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
19 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged between 19 and
  • Acute lower-back pain, persisting less than 6 weeks, meeting the diagnostic classification of 1 or 2 according to the Quebec Task Force on Spinal Disorders

排除标准

  • Previous spine surgery
  • Spinal nerve root irritation or deficits,
  • Pregnant women,
  • Lower-back pain due to occupational accidents
  • Obesity status (body mass index> 30).
  • Chronic lower-back pain longer than 6 weeks.

研究组 & 干预措施

Control: Drug-Only Group

Active Comparator

Patients with acute lower-back pain who have undergone routine conventional drug treatment at the first visit to the emergency department (49 patients). The drug treatment consists of analgesic-anti-inflammatory (diclophenac sodium 75 mg IM) and myorelaxant (thiocolchicoside 4 mg IM), administered only once.

干预措施: diclophenac sodium (75 mg, IM) and thiocolchicoside (4 mg, IM) (Drug)

Case: Drug and Chiropractic Group

Experimental

Patients, who received chiropractic treatment immediately after the conventional drug treatment as in the control group (49 patients). The chiropractic treatment consists of high speed and low amplitude spinal manipulation techniques, applied only once.

干预措施: diclophenac sodium (75 mg, IM) and thiocolchicoside (4 mg, IM) (Drug)

Case: Drug and Chiropractic Group

Experimental

Patients, who received chiropractic treatment immediately after the conventional drug treatment as in the control group (49 patients). The chiropractic treatment consists of high speed and low amplitude spinal manipulation techniques, applied only once.

干预措施: Chiropractic Treatment (Other)

结局指标

主要结局

Change in pain level

时间窗: Up to 30 minutes

Visual Analogue Pain Scale (VAS) assessment at the fifth minute after the injection of drug. Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It uses a ten centimeter scale with a minimum of 0 indicating no pain and a maximum of 10 indicating worst pain.

次要结局

未报告次要终点

研究者

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

ALI TIMUCIN ATAYOGLU

Assistant Prof.

Medipol University

研究点 (1)

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