Reflex Therapy of Temporomandibular Dysfunctions

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-20

Study Completion Date

2026-08-02

Brief Summary

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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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Detailed Description

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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).

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Dry needling

Intervention Type PROCEDURE

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

Standard rehabilitation

Intervention Type PROCEDURE

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

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

Group Type ACTIVE_COMPARATOR

Standard rehabilitation

Intervention Type PROCEDURE

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

Interventions

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Dry needling

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

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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reflex injection therapy of Trigger Point Standard Physical Rehabilitation Program

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No