Reflex Therapy of Temporomandibular Dysfunctions

NCT07321483 | Recruiting

• 1 other identifier: IGA_FZV_2025_015
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effectiveness of dry needling in patients with functional temporomandibular pain syndrome by comparing standard rehabilitation therapy alone with therapy combined with dry needling to reduce pain, improve jaw function and enhance quality of life.

Conditions

Temporomandibular Joint Dysfunction; Myofascial Pain Syndrome; Orofacial Pain; Musculoskeletal Disorders

Keywords

headache; temporomandibular disorders; dry needling; rehabilitation therapy; pain; quality of life; temporomandibular disorders; dry needling; rehabilitation therapy; pain; quality of life

Outcome Measures

Primary Outcomes (1)

• 1. Pain Intensity using the Visual Analogue Scale (VAS).

  * Description: Evaluation of subjective pain intensity in the temporomandibular region assessed using the Visual Analogue Scale (VAS), a continuous scale ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Higher scores indicate worse pain intensity. * Measurement Type: Continuous (0-10 scale).

  Baseline (pre-intervention) Immediately after the first therapy session At completion of the treatment program (after 10 therapy sessions).

Secondary Outcomes (1)

• Temporomandibular Joint (TMJ) Range of Motion, Joint Sound Phenomena and Quality of Life (WHOQOL-BREF)

  Baseline (pre-intervention) Immediately after the first therapy session At completion of the treatment program (after 10 therapy sessions)

Study Arms (2)

Experimental Group: intervention with Dry Needling and Standard Rehabilitation)

EXPERIMENTAL

Participants in this group will receive standard outpatient rehabilitation therapy combined with Intervention: one dry needling intervention targeting trigger points in the masseter and temporalis muscles during the first treatment session. The rehabilitation program will include mobilization, soft tissue techniques, and targeted kinesiotherapy. Each participant will undergo ten outpatient rehabilitation sessions over five weeks (two sessions per week).

Procedure: Dry needling; Procedure: Standard rehabilitation

Control Group - Standard Rehabilitation

ACTIVE COMPARATOR

Participants in this group will receive the same standard outpatient rehabilitation program as the experimental group, excluding the dry needling procedure. The therapy will include mobilization, soft tissue relaxation techniques, and specific exercises focused on improving temporomandibular joint mobility and reducing muscle tension

Procedure: Standard rehabilitation

Interventions

Dry needling PROCEDURE

One dry needling intervention targeting trigger points in the masseter and temporalis muscles during the first treatment session

Also known as: reflex injection therapy of Trigger Point

Experimental Group: intervention with Dry Needling and Standard Rehabilitation)

Standard rehabilitation PROCEDURE

The therapy will include mobilization, soft tissue relaxation techniques, and specific exercises focused on improving temporomandibular joint mobility and reducing muscle tension.

Also known as: Standard Physical Rehabilitation Program

Control Group - Standard Rehabilitation; Experimental Group: intervention with Dry Needling and Standard Rehabilitation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with functional temporomandibular pain syndrome without structural temporomandibular joint damage.
• Aged ≥18 years.
• Stable health condition suitable for outpatient rehabilitation.
• Willingness to participate and ability to follow the therapeutic protocol.

You may not qualify if:

• Presence of degenerative, post-traumatic, or inflammatory changes in the temporomandibular joint.
• Cognitive or psychiatric disorders limiting cooperation.
• Lack of informed consent or non-compliance during treatment

Sponsors & Collaborators

• Palacky University: lead

Study Sites (1)

Faculty of Health Sciences, Palacký University Olomouc, Czech Republic

Olomouc, 77900, Czechia

RECRUITING

Related Publications (3)

• Quilghini C, Lefflot J, Buchholtz K. The effectiveness of physiotherapy for chronic headaches in patients with temporomandibular disorders: a systematic review. Front Rehabil Sci. 2025 Sep 23;6:1647927. doi: 10.3389/fresc.2025.1647927. eCollection 2025.

  PMID: 41064810 RESULT

• Armijo-Olivo S, Pitance L, Singh V, Neto F, Thie N, Michelotti A. Effectiveness of Manual Therapy and Therapeutic Exercise for Temporomandibular Disorders: Systematic Review and Meta-Analysis. Phys Ther. 2016 Jan;96(1):9-25. doi: 10.2522/ptj.20140548. Epub 2015 Aug 20.

  PMID: 26294683 RESULT

• Konečný P, Havlíčková J, Elfmark M, Tvrdý P, Hanáková D, Jureček M. Effects of Rehabilitation in Patients with Temporomandibular Joint Disorders. Rehabil. Fyz. Lek. (2007) 14: 95-100.

  RESULT

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Myofascial Pain Syndromes; Facial Pain; Musculoskeletal Diseases; Headache; Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Central Study Contacts

Petr Konečný, Ph.D, M.D., assoc.prof.

CONTACT

+420604573931; petr.konecny@upol.cz

Dana Dvořáková, MSc.

CONTACT

dana.dvorakova01@upol.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Head of the Institute of Clinical Rehabilitation, Palacký University Olomouc

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: January 7, 2026
• Study Start: September 20, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 2, 2026
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)