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
1 other identifier
interventional
50
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2023
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2023
CompletedFirst Posted
Study publicly available on registry
September 5, 2023
CompletedStudy Start
First participant enrolled
September 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedOctober 15, 2024
August 1, 2023
7 months
August 17, 2023
October 9, 2024
Conditions
Outcome Measures
Primary Outcomes (10)
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)
Study Arms (2)
Control
NO INTERVENTIONdry needle
EXPERIMENTALInterventions
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%).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Universidad de Alcalá de Henares
Madrid, 28801, Spain
Patricia Recio Ramos
Madrid, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2023
First Posted
September 5, 2023
Study Start
September 29, 2023
Primary Completion
April 29, 2024
Study Completion
September 30, 2024
Last Updated
October 15, 2024
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share