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

Whiplash Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06023264
• Other study ID #: 03916375G
• Status: Recruiting
• Phase: N/A
• Start date: September 29, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: August 2023
• Source: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Contact: Patricia Recio Ramos, physiotherapist
• Phone: 915504800
• Email: patricia.recior[@]quironsalud.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 30, 2024
• Est. primary completion date: January 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• Temporomandibular Joint Pain
• Whiplash
• Whiplash Injuries

Intervention

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%).

Locations

Country	Name	City	State
Spain	Patricia Recio Ramos	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Country where clinical trial is conducted

Spain, 

Outcome

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