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Clinical Trials/NCT06023264
NCT06023264CompletedNot Applicable

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 sites in 1 country50 target enrollmentStarted: September 29, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
50
Locations
3
Primary Endpoint
Age

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Age

Time Frame: Visit 1 (First day of treatment)

Years (Demographic variables)

Jaw pain

Time Frame: Visit 1(First day of treatment) and Visit 2 (One week after visit 1)

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

Headache

Time Frame: Visit 1(First day of treatment) and Visit 2 (One week after visit 1)

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

Gender

Time Frame: Visit 1 (First day of treatment)

Male, Female, Does not answer (Demographic variables)

Height

Time Frame: Visit 1 (First day of treatment)

Meters (Demographic variables)

Mouth opening

Time Frame: Visit 1(First day of treatment) and Visit 2 (One week after visit 1)

Millimeters (Basal conditions)

Pressure masseter, pterygoid, and temporalis

Time Frame: 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

Time Frame: 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

Time Frame: Visit 1 (First day of treatment)

Kilograms (Demographic variables)

Joint clicking

Time Frame: Visit 1(First day of treatment) and Visit 2 (One week after visit 1)

Yes/No (Basal conditions)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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