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Completed

NCT Number: NCT06023264

Evaluate the Effect of Dry Needling on the Temporomandibular Joint in Subjects Who Have Suffered a Whiplash as a Result of a Traffic Accident

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.

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Key information

Conditions

Whiplash Dry Needling Technique Neck Injuries Temporomandibular Joint Pain Whiplash Injuries Wounds and Injuries

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Patricia Recio Ramos, Madrid, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dry needling

Procedure

It is a minimally invasive treatment modality. Its effectiveness has been confirmed in numerous studies. It consists of applying an antiseptic in the puncture area and inserting the needle in the required aseptic conditions. During puncture, the patient's physical response is observed at all times, in order to control the local spasmodic responses in each muscle. After applying the technique, we assessed jaw pain, mouth opening, and the appearance of headaches. The adverse effects of the technique are the following: pain after puncture (1.7%), local bleeding at the puncture site (6.1%) and syncopal responses (0.7%).

Primary outcomes

  1. Age

    Time frame: Visit 1 (First day of treatment)

    Years (Demographic variables)

  2. Gender

    Time frame: Visit 1 (First day of treatment)

    Male, Female, Does not answer (Demographic variables)

  3. Weight

    Time frame: Visit 1 (First day of treatment)

    Kilograms (Demographic variables)

  4. Height

    Time frame: Visit 1 (First day of treatment)

    Meters (Demographic variables)

  5. Mouth opening

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

    Millimeters (Basal conditions)

  6. 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)

  7. 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)

  8. Joint clicking

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

    Yes/No (Basal conditions)

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Other

Collaborators

  • University of Alcala

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 5, 2023
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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