WhiplashNCT06023264
Evaluate the Effect of Dry Needling on the Temporomandibular Joint in Subjects Who Have Suffered a Whiplash as a Result of a Traffic Accident
A study testing Dry needling in people with Whiplash and Temporomandibular Joint Pain, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 2 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Whiplash, Temporomandibular Joint Pain, Dry Needling Technique
- What is being tested?
- Dry needling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesSpain
- Study dates
- 29 Sep 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- Fear of needles
- Any neurological disorder (trigeminal neuralgia, epilepsy)
- Pregnancy
- Uncontrolled vascular or metabolic problems
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Universidad de Alcalá de Henares
Madrid, 28801
Patricia Recio Ramos
Madrid
About this study
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
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.
Read more
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.
- Being tested
- Dry needling
- Medical subject headings
- Whiplash Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingProcedure or surgery
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%).
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| dry needle | Experimental | Not described Receives: Procedure: Dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age
Years (Demographic variables)
Measured: Visit 1 (First day of treatment)
Gender
Male, Female, Does not answer (Demographic variables)
Measured: Visit 1 (First day of treatment)
Weight
Kilograms (Demographic variables)
Measured: Visit 1 (First day of treatment)
Height
Meters (Demographic variables)
Measured: Visit 1 (First day of treatment)
Mouth opening
Millimeters (Basal conditions)
Measured: Visit 1(First day of treatment) and Visit 2 (One week after visit 1)
Jaw pain
Visual Analog Scale (VAS) 1-10 (Basal conditions)
Measured: Visit 1(First day of treatment) and Visit 2 (One week after visit 1)
Headache
Visual Analog Scale (VAS) 1-10 (Basal conditions)
Measured: Visit 1(First day of treatment) and Visit 2 (One week after visit 1)
Joint clicking
Yes/No (Basal conditions)
Measured: 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
Measured: 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
Measured: Visit 1(First day of treatment) and Visit 2 (One week after visit 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start29 Sep 2023
- Primary completion29 Apr 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WhiplashStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alcala
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023264
- Sponsor's protocol ID
- 03916375G
- Status last verified
- Aug 2023
- First submitted
- 17 Aug 2023
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06023264
- Acronym / sponsor ID
- 03916375G
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Collaborators
- University of Alcala
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| dry needle | Experimental | Procedure: Dry needling |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry needlingIt 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%). | Procedure or surgery | dry needle |
Primary outcome
Age
Time frame: Visit 1 (First day of treatment)
Years (Demographic variables)
Gender
Time frame: Visit 1 (First day of treatment)
Male, Female, Does not answer (Demographic variables)
Weight
Time frame: Visit 1 (First day of treatment)
Kilograms (Demographic variables)
Height
Time frame: Visit 1 (First day of treatment)
Meters (Demographic variables)
Mouth opening
Time frame: Visit 1(First day of treatment) and Visit 2 (One week after visit 1)
Millimeters (Basal conditions)
Jaw pain
Time frame: Visit 1(First day of treatment) and Visit 2 (One week after visit 1)
Visual Analog Scale (VAS) 1-10 (Basal conditions)
Headache
Time frame: Visit 1(First day of treatment) and Visit 2 (One week after visit 1)
Visual Analog Scale (VAS) 1-10 (Basal conditions)
Joint clicking
Time frame: Visit 1(First day of treatment) and Visit 2 (One week after visit 1)
Yes/No (Basal conditions)
Pressure masseter, pterygoid, and temporalis
Time frame: Visit 1 (First day of treatment)
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
Time frame: Visit 1(First day of treatment) and Visit 2 (One week after visit 1)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry needling in people with Whiplash and Temporomandibular Joint Pain, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age (time frame: Visit 1 (First day of treatment)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.