Dry Needling vs Injection in Patients With Temporomandibular Disorders

NCT04726683 | Unknown

• 1 other identifier: URJC-09/2020
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Temporomandibular Disorders

Keywords

dry needling; Temporomandibular Disorders

Outcome Measures

Primary Outcomes (1)

• Pain perception (Change is being assessed)

  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 Outcomes (16)

• Believability of placebo

  At one week, at two weeks, at three weeks, at for weeks

• Disability

  At baseline, 24h post treatment, at one month, at six months and at twelve months

• Pressure pain threshold (Change is being assessed)

  At baseline, 24h post treatment, at one month, at six months and at twelve months

• Conditioned pain modulation

  At baseline, 24h post treatment, at one month, at six months and at twelve months

• Temporal summation (TS)

  At baseline, 24h post treatment, at one month, at six months and at twelve months

Study Arms (4)

Dry needling

EXPERIMENTAL

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

Procedure: Dry needling and placebo injection

Injection

EXPERIMENTAL

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

Procedure: Injection and placebo dry needling

Placebo

PLACEBO COMPARATOR

Combines sham dry needling + sham injection.

Procedure: Placebo dry needling and placebo injection

Dry needling + Injection

ACTIVE COMPARATOR

Combines experimental dry needling and injection

Procedure: Dry needling and injection

Interventions

Dry needling and placebo injection 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.

Dry needling

Injection and placebo dry needling 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

Injection

Dry needling and injection 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.

Dry needling + Injection

Placebo dry needling and placebo injection 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

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Josue Fernandez Carnero: lead

Study Sites (1)

Clínica Universitaria de la Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Dry Needling; Injections

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Drug Administration Routes; Drug Therapy

Central Study Contacts

Josue Fernandez Carnero, PhD

CONTACT

914888949; josue.fernandez@urjc.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: January 27, 2021
• Study Start: November 23, 2020
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2024
• Last Updated: November 15, 2023

Record last verified: 2023-11

Locations

ES (1)