Dry Needling vs Injection in Patients With Temporomandibular Disorders

November 12, 2023 updated by: Josue Fernandez Carnero

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • Recruiting
        • Clínica Universitaria de la Universidad Rey Juan Carlos
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subjects aged between 18 and 60 years.
  2. Pain of more than 6 weeks of evolution in the craniofacial region.
  3. TMD with origin in the masticatory musculature according to the "DC-TMD" criteria.

Exclusion Criteria:

  1. Previous injection or dry needling intervention (3 months) on the masseter muscle.
  2. Arthrogenous TMD.
  3. History of trauma, infection in the temporomandibular joint in the last 6 months.
  4. Coagulation disorders.
  5. Pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dry needling
Trigger point dry needling on an active myofascial trigger point of the masseter muscle.
Procedure: Dry needling and placebo injection
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.
Experimental: Injection
Trigger point injection of lidocaine on an active myofascial trigger point of the masseter muscle.
Procedure: Injection and placebo dry needling
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
Placebo Comparator: Placebo
Combines sham dry needling + sham injection.
Procedure: Placebo dry needling and placebo injection
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
Active Comparator: Dry needling + Injection
Combines experimental dry needling and injection
Procedure: Dry needling and injection
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
At baseline, 24h post treatment, at one month, at six months and at twelve months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Believability of placebo
Time Frame: At one week, at two weeks, at three weeks, at for weeks
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.
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

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."
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
Digital algometer measure of the pressure pain threshold on the masseter muscle
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
Pressure pain thresholds measure on the distal phalanx of the thumb before and during the application of a noxious stimulus ( Ischemic pain)
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
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).
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
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.
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
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).
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
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
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
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.
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
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.
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
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).
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
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.
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
Interincisal distance measured in cm.
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
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.
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
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.
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
. 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.
At baseline, 24h post treatment, at one month, at six months and at twelve months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Josue Fernandez Carnero

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 23, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • URJC-09/2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Temporomandibular Disorders

Clinical Trials on Dry needling and placebo injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings