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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
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07321483
Enrollment
100
Registered
2026-01-07
Start date
2025-12-20
Completion date
2027-08-02
Last updated
2026-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

headache; temporomandibular disorders; dry needling; rehabilitation therapy; pain; quality of life, temporomandibular disorders; dry needling; rehabilitation therapy; pain; quality of life

Brief 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).

Interventions

PROCEDUREDry needling

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

PROCEDUREStandard rehabilitation

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

Sponsors

Palacky University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
1. Pain Intensity using the Visual Analogue Scale (VAS).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

MeasureTime frameDescription
Temporomandibular Joint (TMJ) Range of Motion, Joint Sound Phenomena and Quality of Life (WHOQOL-BREF)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)

Countries

Czechia

Contacts

CONTACTPetr Konečný, Ph.D, M.D., assoc.prof.
petr.konecny@upol.cz+420604573931
CONTACTDana Dvořáková, MSc.
dana.dvorakova01@upol.cz

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 12, 2026