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

Primary Purpose

Whiplash, Temporomandibular Joint Pain, Dry Needling Technique

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dry needling
Sponsored by
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Whiplash

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Patricia Recio RamosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

dry needle

Arm Description

Outcomes

Primary Outcome Measures

Age
Years (Demographic variables)
Gender
Male, Female, Does not answer (Demographic variables)
Weight
Kilograms (Demographic variables)
Height
Meters (Demographic variables)
Mouth opening
Millimeters (Basal conditions)
Jaw pain
Visual Analog Scale (VAS) 1-10 (Basal conditions)
Headache
Visual Analog Scale (VAS) 1-10 (Basal conditions)
Joint clicking
Yes/No (Basal conditions)
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
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

Secondary Outcome Measures

Full Information

First Posted
August 17, 2023
Last Updated
October 2, 2023
Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
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1. Study Identification

Unique Protocol Identification Number
NCT06023264
Brief Title
Evaluate the Effect of Dry Needling on the Temporomandibular Joint in Subjects Who Have Suffered a Whiplash as a Result of a Traffic Accident
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 29, 2023 (Actual)
Primary Completion Date
January 29, 2024 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Whiplash, Temporomandibular Joint Pain, Dry Needling Technique

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
dry needle
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Dry needling
Intervention Description
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 Outcome Measure Information:
Title
Age
Description
Years (Demographic variables)
Time Frame
Visit 1 (First day of treatment)
Title
Gender
Description
Male, Female, Does not answer (Demographic variables)
Time Frame
Visit 1 (First day of treatment)
Title
Weight
Description
Kilograms (Demographic variables)
Time Frame
Visit 1 (First day of treatment)
Title
Height
Description
Meters (Demographic variables)
Time Frame
Visit 1 (First day of treatment)
Title
Mouth opening
Description
Millimeters (Basal conditions)
Time Frame
Visit 1(First day of treatment) and Visit 2 (One week after visit 1)
Title
Jaw pain
Description
Visual Analog Scale (VAS) 1-10 (Basal conditions)
Time Frame
Visit 1(First day of treatment) and Visit 2 (One week after visit 1)
Title
Headache
Description
Visual Analog Scale (VAS) 1-10 (Basal conditions)
Time Frame
Visit 1(First day of treatment) and Visit 2 (One week after visit 1)
Title
Joint clicking
Description
Yes/No (Basal conditions)
Time Frame
Visit 1(First day of treatment) and Visit 2 (One week after visit 1)
Title
Pressure masseter, pterygoid, and temporalis
Description
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
Time Frame
Visit 1 (First day of treatment)
Title
Pain masseter, pterygoid, and temporalis
Description
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
Time Frame
Visit 1(First day of treatment) and Visit 2 (One week after visit 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Recio Ramos, physiotherapist
Phone
915504800
Ext
3279
Email
patricia.recior@quironsalud.es
Facility Information:
Facility Name
Patricia Recio Ramos
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Recio Ramos, physiotherapist
Phone
915504800
Ext
3279
Email
patricia.recior@quironsalud.es

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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