NCT06023264

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

2 active sites

Status
completed

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

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 5, 2023

Completed
24 days until next milestone

Study Start

First participant enrolled

September 29, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

October 15, 2024

Status Verified

August 1, 2023

Enrollment Period

7 months

First QC Date

August 17, 2023

Last Update Submit

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 INTERVENTION

dry needle

EXPERIMENTAL
Procedure: Dry needling

Interventions

Dry needlingPROCEDURE

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%).

dry needle

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

Patricia Recio Ramos

Madrid, Spain

Location

MeSH Terms

Conditions

Whiplash Injuries

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Neck InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

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

Locations