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临床试验/NCT06023264
NCT06023264已完成不适用

Randomized, Open Clinical Trial to Evaluate the Effect of Dry Needling on the Temporomandibular Joint in Subjects Who Have Suffered a Whiplash as a Result of a Traffic Accident

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz3 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年9月29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
50
试验地点
3
主要终点
Age

研究概览

简要总结

The transportation industry is growing rapidly and the most popular mode is overland by road. Traffic accidents are the most direct and serious risk to the lives of Western people. A large number of traffic accidents occur on the roads each year, especially those caused by motor vehicles on motorways and urban ring roads, often resulting in massive loss of life. According to the World Health Organization (WHO), 1.35 million people die each year worldwide.

Whiplash is the most common injury in motor vehicle collisions, affecting 83% of injured people.

The temporomandibular joint (TMJ) is one of the most complex joints in the human body, since in addition to performing functions in dental occlusion, it does so in the neuromuscular system.

Due to the relationship of the neck with the mandible, the main objective of the study is to determine if there is an improvement in pain and functional limitation in general by applying the dry needling technique in the temporomandibular joint musculature.

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
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Having suffered a traffic accident
  • Having suffered a subsequent collision
  • Having been diagnosed with whiplash in the hospital ''Fundación Jiménez Díaz (FJD)´´ emergency room in the first 72 hours after the collision.
  • Age between 18-45 years, to avoid osteoarthritis and other degenerative problems.
  • Minimum 3 in temporomandibular joint (TMJ) according to Visual Analog Scale (VAS)
  • Consent to participate

排除标准

  • Temporomandibular joint (TMJ) or craniofacial surgeries
  • Spinal surgery
  • Direct trauma in temporomandibular joint (TMJ) or prior to the accident
  • Botox, silicones or any type of cosmetic surgery in the facial region.
  • Problems of migraines and tension headaches (pre-accident)
  • Any degenerative musculoskeletal disease (fibromyalgia, rheumatoid arthritis, osteoarthritis)
  • Fear of needles
  • Any neurological disorder (trigeminal neuralgia, epilepsy)
  • Pregnancy
  • Uncontrolled vascular or metabolic problems

结局指标

主要结局

Age

时间窗: Visit 1 (First day of treatment)

Years (Demographic variables)

Jaw pain

时间窗: Visit 1(First day of treatment) and Visit 2 (One week after visit 1)

Visual Analog Scale (VAS) 1-10 (Basal conditions)

Headache

时间窗: Visit 1(First day of treatment) and Visit 2 (One week after visit 1)

Visual Analog Scale (VAS) 1-10 (Basal conditions)

Gender

时间窗: Visit 1 (First day of treatment)

Male, Female, Does not answer (Demographic variables)

Height

时间窗: Visit 1 (First day of treatment)

Meters (Demographic variables)

Mouth opening

时间窗: Visit 1(First day of treatment) and Visit 2 (One week after visit 1)

Millimeters (Basal conditions)

Pressure masseter, pterygoid, and temporalis

时间窗: Visit 1 (First day of treatment)

Determine pressure in kg in the masseter, temporal, and pterygoid muscles with an algometer to obtain 5/10 in Visual Analog Scale (VAS) to all participants

Pain masseter, pterygoid, and temporalis

时间窗: Visit 1(First day of treatment) and Visit 2 (One week after visit 1)

Obtain pain from 1 to 10 in the masseter, temporal, and pterygoid muscles according to the Visual Analog Scale (VAS) after applying the pressure obtained with the algometer in the previous step. \*Patients in the experimental group are evaluated 10 minutes after the application of dry needling

Weight

时间窗: Visit 1 (First day of treatment)

Kilograms (Demographic variables)

Joint clicking

时间窗: Visit 1(First day of treatment) and Visit 2 (One week after visit 1)

Yes/No (Basal conditions)

次要结局

未报告次要终点

研究者

发起方
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
申办方类型
Other
责任方
Sponsor

研究点 (3)

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