Reflex Therapy of Temporomandibular Dysfunctions

Palacky University

Status: Enrolling

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

Treatments: Procedure: Dry needling; Procedure: Standard rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT07321483

IGA_FZV_2025_015

Details and patient eligibility

About

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.

Full 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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Experimental Group: intervention with Dry Needling and Standard Rehabilitation)

Experimental group

Description:

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).

Treatment:

Procedure: Standard rehabilitation

Procedure: Dry needling

Control Group - Standard Rehabilitation

Active Comparator group

Description:

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

Treatment:

Procedure: Standard rehabilitation