Reflex Therapy of Temporomandibular Dysfunctions

December 28, 2025 updated by: Petr Konecny, Palacky University

Evaluation of the Therapeutic Efficacy of Reflex Therapy Using Dry Needling in Patients With Functional Temporomandibular Pain Syndrome: A Prospective, Randomized, Controlled Pilot Study.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This prospective, randomized, controlled pilot study aims to evaluate the therapeutic effects of dry needling in patients with functional temporomandibular pain syndrome. A total of 100 participants will be randomly assigned to two groups: an experimental group receiving standard rehabilitation combined with dry needling therapy, and a control group undergoing standard rehabilitation only. The intervention program will consist of ten outpatient rehabilitation sessions conducted over five weeks.

Outcome measures will include pain intensity (Visual Analogue Scale, VAS), temporomandibular joint range of motion, presence of joint sound phenomena, and quality of life assessed using the World Health Organization Quality of Life - BREF questionnaire (WHOQOL-BREF questionnaire). Measurements will be collected at baseline, immediately after the first therapy session, and upon completion of the treatment cycle.

Descriptive statistics will be used for data analysis. The Shapiro-Wilk test will assess data normality. Between-group differences will be analyzed using parametric (t-test) or nonparametric (Mann-Whitney, Wilcoxon) tests, depending on data distribution. Correlation analyses will be performed using Pearson's or Spearman's correlation coefficients. Statistical significance will be set at p < 0.05.

All statistical analyses will be conducted using IBM SPSS Statistics for Windows, version 29.0 (Armonk, NY, USA).

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • 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

  • Name: Petr Konečný, Ph.D, M.D., assoc.prof.
  • Phone Number: +420604573931
  • Email: petr.konecny@upol.cz

Study Contact Backup

Study Locations

  • Czechia
      • Olomouc, Czechia, 77900
        • Recruiting
        • Faculty of Health Sciences, Palacký University Olomouc, Czech Republic
        • Contact:
        • Contact:
        • Principal Investigator:
          • PETR Konečný, Ph.D., MBA, assoc.prof.
        • Sub-Investigator:
          • Dana Dvorakova, MSc.

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group: intervention with Dry Needling and Standard Rehabilitation)
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
One dry needling intervention targeting trigger points in the masseter and temporalis muscles during the first treatment session
Other Names:
  • reflex injection therapy of Trigger Point
Procedure: Standard rehabilitation
The therapy will include mobilization, soft tissue relaxation techniques, and specific exercises focused on improving temporomandibular joint mobility and reducing muscle tension.
Other Names:
  • Standard Physical Rehabilitation Program
Active Comparator: Control Group - Standard Rehabilitation
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
The therapy will include mobilization, soft tissue relaxation techniques, and specific exercises focused on improving temporomandibular joint mobility and reducing muscle tension.
Other Names:
  • Standard Physical Rehabilitation Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. Pain Intensity using the Visual Analogue Scale (VAS).
Time Frame: Baseline (pre-intervention) Immediately after the first therapy session At completion of the treatment program (after 10 therapy sessions).
  • 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Temporomandibular Joint (TMJ) Range of Motion, Joint Sound Phenomena and Quality of Life (WHOQOL-BREF)
Time Frame: Baseline (pre-intervention) Immediately after the first therapy session At completion of the treatment program (after 10 therapy sessions)
  • Description: Measurement of maximal mouth opening and mandibular movement range using a caliper to assess functional improvement of the TMJ.
  • Measurement Type: Continuous (millimeters). and
  • Description: Clinical assessment of the presence or absence of joint sounds (clicking, popping, or crepitation) during mandibular movement as an indicator of TMJ functional stability.
  • Measurement Type: Categorical (present/absent). and
  • Description: Evaluation of overall quality of life using the WHOQOL-BREF questionnaire, which assesses physical, psychological, social, and environmental domains.
  • Measurement Type: Continuous (score-based)
Baseline (pre-intervention) Immediately after the first therapy session At completion of the treatment program (after 10 therapy sessions)

Collaborators and Investigators

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

Sponsor

Palacky University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 20, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 2, 2026

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

December 28, 2025

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

December 28, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IGA_FZV_2025_015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to patient privacy and institutional data protection policies

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.

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