Clinical Trials Directory

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RecruitingNCT07321483

Reflex Therapy of Temporomandibular Dysfunctions

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
Palacky University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

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).

Conditions

Interventions

TypeNameDescription
PROCEDUREDry needlingOne dry needling intervention targeting trigger points in the masseter and temporalis muscles during the first treatment session
PROCEDUREStandard rehabilitationThe therapy will include mobilization, soft tissue relaxation techniques, and specific exercises focused on improving temporomandibular joint mobility and reducing muscle tension.

Timeline

Start date
2025-09-20
Primary completion
2026-07-01
Completion
2026-08-02
First posted
2026-01-07
Last updated
2026-01-07

Locations

1 site across 1 country: Czechia

Source: ClinicalTrials.gov record NCT07321483. Inclusion in this directory is not an endorsement.