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NCT Number: NCT07321483

Reflex Therapy of Temporomandibular Dysfunctions

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.

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Key information

Conditions

Temporomandibular Joint Dysfunction; Myofascial Pain Syndrome; Orofacial Pain; Musculoskeletal Disorders Craniomandibular Disorders Facial Pain Headache Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Health Sciences, Palacký University Olomouc, Czech Republic

Olomouc, 77900, Czechia

Location status: Recruiting

Location contact

Dana Dvorakova, MSc.

SUB_INVESTIGATOR

Dana Dvořáková, MSc.

CONTACT

[email protected]

+420604573931

PETR Konečný, Ph.D., M.D.; assoc.prof.

CONTACT

[email protected]

+420604573931

PETR Konečný, Ph.D., MBA, assoc.prof.

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dry needling

Procedure

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

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.

Other names: Standard Physical Rehabilitation Program

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Dana Dvořáková, MSc.

CONTACT

[email protected]

Petr Konečný, Ph.D, M.D., assoc.prof.

CONTACT

[email protected]

+420604573931

Sponsors and collaborators

Lead sponsor

Palacky University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 7, 2026
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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