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Recruiting NCT07321483

Reflex Therapy of Temporomandibular Dysfunctions

No phase Interventional Temporomandibular Joint Dysfunction; Myofascial Pain Syndrome; Orofacial Pain; Musculoskeletal Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dry needling, Standard rehabilitation.
Who it may be relevant to
Registry conditions: Temporomandibular Joint Dysfunction; Myofascial Pain Syndrome; Orofacial Pain; Musculoskeletal Disorders. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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.

Overview

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).

Interventions

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

Primary outcome measures

  • 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).]
Secondary outcome measures (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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Czechia · 1 center
  • Faculty of Health Sciences, Palacký University Olomouc, Czech Republic — Olomouc

Publications

  • 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
  • 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
  • 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.

Identifiers

NCT: NCT07321483 · IGA_FZV_2025_015

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗