An interventional study of Dry needling and Standard rehabilitation in Temporomandibular Joint Dysfunction; Myofascial Pain Syndrome; Orofacial Pain; Musculoskeletal Disorders, sponsored by Palacky University. Recruiting at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Palacky University · Not applicable, Interventional, and Treatment
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.
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).
591 studies on the registry are indexed under Temporomandibular Joint Disorders; 149 are open to participants now.
This study's planned enrollment of 100 is above the median of 45 across 415 interventional studies indexed under Temporomandibular Joint Disorders.
Browse Temporomandibular Joint Disorders studies →Palacky University is the lead sponsor of 32 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Procedure: Dry needling · Procedure: 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
Procedure: Standard rehabilitation
One dry needling intervention targeting trigger points in the masseter and temporalis muscles during the first treatment session
Also known as: reflex injection therapy of Trigger Point
The therapy will include mobilization, soft tissue relaxation techniques, and specific exercises focused on improving temporomandibular joint mobility and reducing muscle tension.
Also known as: Standard Physical Rehabilitation Program
1. Pain Intensity using the Visual Analogue Scale (VAS).
* 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).
Time frame: Baseline (pre-intervention) Immediately after the first therapy session At completion of the treatment program (after 10 therapy sessions).
Temporomandibular Joint (TMJ) Range of Motion, Joint Sound Phenomena and Quality of Life (WHOQOL-BREF)
* 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)
Time frame: Baseline (pre-intervention) Immediately after the first therapy session At completion of the treatment program (after 10 therapy sessions)
Plan to share: No — Individual participant data will not be shared due to patient privacy and institutional data protection policies
Started Dec 2025 (actual). Primary completion is estimated for Dec 2026, 11 months after the start.
Of 242 non-industry interventional studies with no phase under Temporomandibular Joint Disorders, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 21. This study's planned 11 months is close to that.
Counting every sponsor, half of 246 studies reached it within 10 months; a quarter within 5 and three quarters within 21.
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