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

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

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 Overview

• Status: Recruiting
• Conditions: Whiplash; Temporomandibular Joint Pain; Dry Needling Technique
• Intervention / Treatment: Procedure: Dry needling

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patricia Recio Ramos, physiotherapist; Phone Number: 3279 915504800; Email: patricia.recior@quironsalud.es

Study Locations

• Spain
  • Madrid, Spain
    • Recruiting
    • Patricia Recio Ramos
    • Contact: Patricia Recio Ramos, physiotherapist; Phone Number: 3279 915504800; Email: patricia.recior@quironsalud.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: dry needle	Procedure: Dry needling; 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%).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Years (Demographic variables)	Visit 1 (First day of treatment)
Gender	Male, Female, Does not answer (Demographic variables)	Visit 1 (First day of treatment)
Weight	Kilograms (Demographic variables)	Visit 1 (First day of treatment)
Height	Meters (Demographic variables)	Visit 1 (First day of treatment)
Mouth opening	Millimeters (Basal conditions)	Visit 1(First day of treatment) and Visit 2 (One week after visit 1)
Jaw pain	Visual Analog Scale (VAS) 1-10 (Basal conditions)	Visit 1(First day of treatment) and Visit 2 (One week after visit 1)
Headache	Visual Analog Scale (VAS) 1-10 (Basal conditions)	Visit 1(First day of treatment) and Visit 2 (One week after visit 1)
Joint clicking	Yes/No (Basal conditions)	Visit 1(First day of treatment) and Visit 2 (One week after visit 1)
Pressure masseter, pterygoid, and temporalis	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	Visit 1 (First day of treatment)
Pain masseter, pterygoid, and temporalis	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	Visit 1(First day of treatment) and Visit 2 (One week after visit 1)

Collaborators and Investigators

• Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2023
• Primary Completion (Estimated): January 29, 2024
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: August 17, 2023
• First Submitted That Met QC Criteria: August 28, 2023
• First Posted (Actual): September 5, 2023

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Neck Injuries; Arthralgia; Whiplash Injuries
• Other Study ID Numbers: 03916375G

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No