Dry Needling vs Injection in Patients With Temporomandibular Disorders

NCT ID: NCT04726683

Last Updated: 2023-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-23

Study Completion Date

2024-12-15

Brief Summary

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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.

Detailed Description

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Conditions

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Temporomandibular Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Dry needling

Trigger point dry needling on an active myofascial trigger point of the masseter muscle.

Group Type EXPERIMENTAL

Dry needling and placebo injection

Intervention Type PROCEDURE

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

Trigger point injection of lidocaine on an active myofascial trigger point of the masseter muscle.

Group Type EXPERIMENTAL

Injection and placebo dry needling

Intervention Type PROCEDURE

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

Combines sham dry needling + sham injection.

Group Type PLACEBO_COMPARATOR

Placebo dry needling and placebo injection

Intervention Type PROCEDURE

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

Dry needling + Injection

Combines experimental dry needling and injection

Group Type ACTIVE_COMPARATOR

Dry needling and injection

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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

Intervention Type 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.

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Josue Fernandez Carnero

OTHER

Sponsor Role lead

Responsible Party

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Josue Fernandez Carnero

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Clínica Universitaria de la Universidad Rey Juan Carlos

Alcorcón, Madrid, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Josue Fernandez Carnero, PhD

Role: CONTACT

914888949

Facility Contacts

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Josue Fernandez-Carnero, Phd

Role: primary

+34 91 4888949

Other Identifiers

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URJC-09/2020

Identifier Type: -

Identifier Source: org_study_id

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