Temporomandibular DisordersNCT04726683
Dry Needling vs Injection in Patients With Temporomandibular Disorders
A study testing Dry needling and injection in people with Temporomandibular Disorders, run by Josue Fernandez Carnero at 1 site in Spain.
Trial summary
The main objective is to compare the effectiveness of dry needling in improving pain and disability versus placebo, and versus infiltration, in patients with myofascial temporomandibular dysfunction in the short, medium and long term. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Temporomandibular Disorders
- What is being tested?
- Dry needling and injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteSpain
- Study dates
- 23 Nov 2020to 15 Dec 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects aged between 18 and 60 years.
- Pain of more than 6 weeks of evolution in the craniofacial region.
- TMD with origin in the masticatory musculature according to the "DC-TMD" criteria.
Who cannot join
- Previous injection or dry needling intervention (3 months) on the masseter muscle.
- Arthrogenous TMD.
- History of trauma, infection in the temporomandibular joint in the last 6 months.
- Coagulation disorders.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Clínica Universitaria de la Universidad Rey Juan Carlos
Alcorcón, Madrid, 28922
Josue Fernandez-Carnero, Phd, +34 91 4888949, josue.fernandez@urjc.es
About this study
Official title: Trigger Point Dry Needling vs Injection in Patients With Temporomandibular Disorders: a Randomized Placebo-controlled Trial
The main objective is to compare the effectiveness of dry needling in improving pain and disability versus placebo, and versus infiltration, in patients with myofascial temporomandibular dysfunction in the short, medium and long term.
- Conditions
- Temporomandibular Disorders
- Being tested
- Dry needling and placebo injection, Injection and placebo dry needling, Dry needling and injection, Placebo dry needling and placebo injection
- Keywords
- dry needling, Temporomandibular Disorders
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needling and placebo injectionProcedure or surgery
Dry Needling is applied with a filiform needle to penetrate the skin and stimulate the underlying myofascial trigger point of the masseter muscle. Dry needling is combined with placebo injection, in which the tip of a beveled needle is cut and the process of injection is simulated without penetrating the skin.
Injection and placebo dry needlingProcedure or surgery
Lidocaine injection applied in the myofascial trigger point of the masseter muscle. Lidocaine injection is combined with placebo dry needling, in which the tip of a filiform needle is cut and the dry needling technique simulated without penetrating the skin
Dry needling and injectionProcedure or surgery
Dry Needling is applied with a filiform needle to penetrate the skin and stimulate the underlying myofascial trigger point of the masseter muscle. Dry needling is combined with lidocaine injection applied in the myofascial trigger point of the masseter muscle.
Placebo dry needling and placebo injectionProcedure or surgery
Placebo dry needling, in which the tip of a filiform needle is cut and the dry needling technique simulated without penetrating the skin. Placebo dry needling is combined with placebo injection, in which the tip of a beveled needle is cut and the process of injection is simulated without penetrating the skin
| Study group | Role | What they receive |
|---|---|---|
| Dry needling | Experimental | Trigger point dry needling on an active myofascial trigger point of the masseter muscle. Receives: Procedure: Dry needling and placebo injection |
| Injection | Experimental | Trigger point injection of lidocaine on an active myofascial trigger point of the masseter muscle. Receives: Procedure: Injection and placebo dry needling |
| Placebo | Placebo comparator | Combines sham dry needling + sham injection. Receives: Procedure: Placebo dry needling and placebo injection |
| Dry needling + Injection | Active comparator | Combines experimental dry needling and injection Receives: Procedure: Dry needling and injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain perception (Change is being assessed)
Self reported Visual Analog Scale. Minimum value is 0 (best); Maximun value is 10 (worst).
Measured: At baseline, 24h post treatment, at one month, at six months and at twelve months
Secondary outcomes (16)
Believability of placebo
Patients beliefs about group allocation: A scale of cale of four options (Experimental Dry needling / Experimental Injection / Placebo Comparator / Active Comparator) in which patients had to indicate which intervention they believe they have received during the treatment sessions.
Measured: At one week, at two weeks, at three weeks, at for weeks
Disability
Self-reported disability questionnaire: Craniofacial Pain and Disability Inventory (CF-PDI).
The CF-PDI contains 21 items divided into 2 subscales according to their content and exploratory factor analysis: "pain and disability" and "jaw functional status."
Measured: At baseline, 24h post treatment, at one month, at six months and at twelve months
Pressure pain threshold (Change is being assessed)
Digital algometer measure of the pressure pain threshold on the masseter muscle
Measured: At baseline, 24h post treatment, at one month, at six months and at twelve months
Conditioned pain modulation
Pressure pain thresholds measure on the distal phalanx of the thumb before and during the application of a noxious stimulus ( Ischemic pain)
Measured: At baseline, 24h post treatment, at one month, at six months and at twelve months
Temporal summation (TS)
Initially, a needlle stimulus is measured locally and distally. Then, the TS is triggered by 10 consecutive pressures on the PPT at the pressure determined at each location. For each pulse, the pressure was gradually increased at a rate of 2 kg/s at the determined PPT and held for 1 s before being released (with an interval of one second between each stimulus).
Measured: At baseline, 24h post treatment, at one month, at six months and at twelve months
Beck Depression Inventory (BDI)
The level of depressive symptomatology was measured by the Spanish version of the Beck Depression Inventory (BDI-II); a 21-item self-report rating scale that assesses affective, cognitive and somatic symptoms of depression. Each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms.
Measured: At baseline, 24h post treatment, at one month, at six months and at twelve months
Anxiety (STAI questionnaire)
The state-trait anxiety inventory (STAI) is a questionnaire that measures trait anxiety (a personality factor that predisposes the patient to suffer from anxiety) and the state of anxiety (environmental factors that protect or generate anxiety). Each of the two sub-scales (trait anxiety and state anxiety) consists of 20 items, ranging from 0 (nothing) to 3 (a lot).
Measured: At baseline, 24h post treatment, at one month, at six months and at twelve months
Kinesiophobia (TAMPA scale)
Tampa Scale for Kinesiophobia. To assess the fear of movement and pain-related fear. The 11 items are scored 1-4, with total scores ranging from 11 to 44. The addition of all the points obtained from each of the items results in the level of kinesiophobia, with higher scores indicating greater perceived kinesiophobia
Measured: At baseline, 24h post treatment, at one month, at six months and at twelve months
Fair avoidance beliefs (FAB questionnaire)
Fear-avoidance Beliefs Questionnaire . The instrument consists of two subscales, a four-item physical activity subscale, and a seven-item work subscale. Each item is scored from 0 to 6 and summed to produce the subscale score. Possible scores range from 0-28 to 0-42, with higher scores indicating greater fear avoidance beliefs.
Measured: At baseline, 24h post treatment, at one month, at six months and at twelve months
Pain catastrophizing (PCS)
Pain catastrophizing Scale (PCS). This tool is a 13-item questionnaire designed to measure the three components of pain-related catastrophizing: rumination, magnification, and helplessness, resulting in a unique score. Each item is responded to on a 5-point scale (0 not at all, 4 all the time) relating the degree to which the individual experiences a thought or feeling of a painful situation.
Measured: At baseline, 24h post treatment, at one month, at six months and at twelve months
Expectation of improvement
Patients´ expectations of pain improvement after the intervention. Patients report their estimated pain perception after the treatment by completing a Self reported Visual Analog Scale. Minimum value is 0 (best); Maximun value is 10 (worst).
Measured: Baseline, at one week, at two weeks, at three weeks, at for weeks
Central sensitization inventory
It serves to identify the symptoms related to central sensitization. It consists of 25 items that are scored from 0: never to 4: always reaching a maximum score of 100. Results are interpreted as follows: subclinical = 0 to 29; mild = 30 to 39; moderate = 40 to 49; severe = 50 to 59; and extreme = 60 to 100.
Measured: At baseline, 24h post treatment, at one month, at six months and at twelve months
Mandibular Dynamic
Interincisal distance measured in cm.
Measured: At baseline, 24h post treatment, at one month, at six months and at twelve months
Neuropathic pain
The presence of neuropathic pain will be assessed using the DN4 questionnaire validated in Spanish. This clinician-administered questionnaire consists of 10 questions. Seven of them are related to the quality of pain and are based on the patient interview, and the remaining three are based on clinical examination according to the presence or absence of hypoesthesia and tactile allodynia to pressure and touch.
Measured: At baseline, 24h post treatment, at one month, at six months and at twelve months
Pain body map
The patient will be asked to paint the areas where he/she presents pain. This map consists of a representation of a person drawn in an anterior, posterior and two lateral planes. The drawing is in a grid of 10mm x 10mm, 16mm x 16 mm cells, up to a maximum of 256 cells.
Measured: At baseline, 24h post treatment, at one month, at six months and at twelve months
EQ-5D
. It consists of two parts: the descriptive EQ-5D system and the VAS. It is a generic and standardized questionnaire, self-administered, simple to answer and with low cognitive load.
Measured: At baseline, 24h post treatment, at one month, at six months and at twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start23 Nov 2020
- Primary completion15 Dec 2023 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisordersStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Josue Fernandez Carnero
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Josue Fernandez Carnero, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726683
- Sponsor's protocol ID
- URJC-09/2020
- Status last verified
- Nov 2023
- First submitted
- 13 Nov 2020
- Last updated
- 15 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trigger Point Dry Needling vs Injection in Patients With Temporomandibular Disorders: a Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04726683
- Acronym / sponsor ID
- URJC-09/2020
- Conditions
- Temporomandibular Disorders
- Keywords
- dry needling, Temporomandibular Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Josue Fernandez CarneroUniversity, hospital or other
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 27 Jan 2021 (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 main objective is to compare the effectiveness of dry needling in improving pain and disability versus placebo, and versus infiltration, in patients with myofascial temporomandibular dysfunction in the short, medium and long term.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dry needling | Experimental | Procedure: Dry needling and placebo injectionTrigger point dry needling on an active myofascial trigger point of the masseter muscle. |
| Injection | Experimental | Procedure: Injection and placebo dry needlingTrigger point injection of lidocaine on an active myofascial trigger point of the masseter muscle. |
| Placebo | Placebo comparator | Procedure: Placebo dry needling and placebo injectionCombines sham dry needling + sham injection. |
| Dry needling + Injection | Active comparator | Procedure: Dry needling and injectionCombines experimental dry needling and injection |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects aged between 18 and 60 years.
- Pain of more than 6 weeks of evolution in the craniofacial region.
- TMD with origin in the masticatory musculature according to the "DC-TMD" criteria.
Key exclusion criteria (5 listed)
- Previous injection or dry needling intervention (3 months) on the masseter muscle.
- Arthrogenous TMD.
- History of trauma, infection in the temporomandibular joint in the last 6 months.
- Coagulation disorders.
- Pregnancy.
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 needling and placebo injectionDry Needling is applied with a filiform needle to penetrate the skin and stimulate the underlying myofascial trigger point of the masseter muscle. Dry needling is combined with placebo injection, in which the tip of a beveled needle is cut and the process of injection is simulated without penetrating the skin. | Procedure or surgery | Dry needling |
| Injection and placebo dry needlingLidocaine injection applied in the myofascial trigger point of the masseter muscle. Lidocaine injection is combined with placebo dry needling, in which the tip of a filiform needle is cut and the dry needling technique simulated without penetrating the skin | Procedure or surgery | Injection |
| Dry needling and injectionDry Needling is applied with a filiform needle to penetrate the skin and stimulate the underlying myofascial trigger point of the masseter muscle. Dry needling is combined with lidocaine injection applied in the myofascial trigger point of the masseter muscle. | Procedure or surgery | Dry needling + Injection |
| Placebo dry needling and placebo injectionPlacebo dry needling, in which the tip of a filiform needle is cut and the dry needling technique simulated without penetrating the skin. Placebo dry needling is combined with placebo injection, in which the tip of a beveled needle is cut and the process of injection is simulated without penetrating the skin | Procedure or surgery | Placebo |
Primary outcome
Pain perception (Change is being assessed)
Time frame: At baseline, 24h post treatment, at one month, at six months and at twelve months
Self reported Visual Analog Scale. Minimum value is 0 (best); Maximun value is 10 (worst).
16 secondary outcomes
Believability of placebo
Time frame: At one week, at two weeks, at three weeks, at for weeks
Disability
Time frame: At baseline, 24h post treatment, at one month, at six months and at twelve months
Pressure pain threshold (Change is being assessed)
Time frame: At baseline, 24h post treatment, at one month, at six months and at twelve months
Conditioned pain modulation
Time frame: At baseline, 24h post treatment, at one month, at six months and at twelve months
Temporal summation (TS)
Time frame: At baseline, 24h post treatment, at one month, at six months and at twelve months
Beck Depression Inventory (BDI)
Time frame: At baseline, 24h post treatment, at one month, at six months and at twelve months
Anxiety (STAI questionnaire)
Time frame: At baseline, 24h post treatment, at one month, at six months and at twelve months
Kinesiophobia (TAMPA scale)
Time frame: At baseline, 24h post treatment, at one month, at six months and at twelve months
Fair avoidance beliefs (FAB questionnaire)
Time frame: At baseline, 24h post treatment, at one month, at six months and at twelve months
Pain catastrophizing (PCS)
Time frame: At baseline, 24h post treatment, at one month, at six months and at twelve months
Expectation of improvement
Time frame: Baseline, at one week, at two weeks, at three weeks, at for weeks
Central sensitization inventory
Time frame: At baseline, 24h post treatment, at one month, at six months and at twelve months
Mandibular Dynamic
Time frame: At baseline, 24h post treatment, at one month, at six months and at twelve months
Neuropathic pain
Time frame: At baseline, 24h post treatment, at one month, at six months and at twelve months
Pain body map
Time frame: At baseline, 24h post treatment, at one month, at six months and at twelve months
EQ-5D
Time frame: At baseline, 24h post treatment, at one month, at six months and at twelve months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry needling and injection in people with Temporomandibular Disorders, run by Josue Fernandez Carnero at 1 site 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Josue Fernandez Carnero, PhD (914888949, josue.fernandez@urjc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain perception (Change is being assessed) (time frame: At baseline, 24h post treatment, at one month, at six months and at twelve months). 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 Nov 2023.