Effect of Manual Therapy on Temporomandibular Joint Dysfunction

NCT07210957 | Completed

• 1 other identifier: AIBU-FTR-RK-12
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Temporomandibular disorders (TMD) are multifactorial conditions involving the temporomandibular joint and masticatory muscles, often presenting with pain and functional limitations. Conventional management includes splints, pharmacological approaches, physiotherapy, and manual therapy. This study aims to evaluate the effects of manual therapy compared to therapeutic exercise on muscle thickness, pain pressure threshold, range of motion, pain, mandibular function, and anxiety in individuals with TMD.

Conditions

Temporomandibular Disorder; Neck Pain

Keywords

Ultrasound; Muscle Thickness; Manual Therapy

Outcome Measures

Primary Outcomes (1)

• Ultrasound Assessment

  Muscle thickness of the masseter and temporalis will be measured with a linear probe in neutral rest and during submaximal teeth clenching (supine). The probe will be aligned to standard anatomical landmarks, kept perpendicular to the skin without compressing soft tissue. Thickness will be recorded in millimeters as the distance between the internal and external fascia. Each muscle will be assessed once per condition.

  Baseline, sixth week

Secondary Outcomes (5)

• Pain Pressure Threshold

  Baseline, sixth week

• Maximum Mouth Opening and Lateral Excursion

  Baseline, sixth week

• Mandibular Function Scale

  Baseline, sixth week

• State-Trait Anxiety Inventory

  Baseline, sixth week

• Generalized Anxiety Disorder Scale

  Baseline, sixth week

Study Arms (2)

Manual therapy

OTHER

The manual therapy sessions implemented to individuals, will include one session per week for 6 weeks, will be lasted about 40-45 minutes. Myofascial techniques will be implemented to masseter, temporalis, suboccipital, scalene, levator scapula and trapezius muscles. These techniques will be lasted for 90 seconds and using with a sliding motion between the origin and insertion of the muscles. Dura mater (dural tube traction), suboccipital muscle release, pterygopalatine ganglion technique, and C0-C1-C2 mobilization as osteopathic techniques will be implemented.

Other: Manual Therapy

Sham manual therapy

SHAM COMPARATOR

The control group will receive sham manual therapy protocol. Sham manual therapy includes implementations conducted under the same conditions and positions, however, without any therapeutic effect. The duration of each session will be lasted around 40-45 minutes (same as the therapy in the intervention group). The sham techniques will be implemented such as light contact by the therapist's hands, the impression of tissue manipulation, the touches with the effect of gravity and the performing non-therapeutic pressure to muscles.

Other: Sham manual therapy

Interventions

Manual Therapy OTHER

Myofascial Release: Myofascial techniques will be implemented to masseter, temporalis, suboccipital, scalene, levator scapula and trapezius muscles. These techniques will be lasted for 90 seconds and using with a sliding motion between the origin and insertion of the muscles. Trigger Point Therapy: The ischemic compression approach will be implemented for 45-60 seconds to stretch the soft tissue over the trigger points of muscles. The emphasis will be on masseter, temporalis and scalene muscles . The emphasis will be on the fascial chains of cranio-cervical and cranio-mandibular transition areas.

Manual therapy

Sham manual therapy OTHER

The duration of each session will be lasted around 40-45 minutes (same as the therapy in the intervention group). The sham techniques will be implemented such as light contact by the therapist's hands, the impression of tissue manipulation, the touches with the effect of gravity and the performing non-therapeutic pressure to muscles. These sham techniques will not be implemented to the actual treatment points; however, they will be on the neck and jaw regions.

Sham manual therapy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Myalgia, and both myalgia and arthralgia according to Diagnostic Criteria for Temporomandibular Disorders
• Completing signing the informed consent form

You may not qualify if:

• Any rheumatological or metabolic disease
• Receiving any treatment for temporomandibular joint in the last 2 years (such as botulinum toxin, manual therapy, splint, orthodontics)
• A history of traumatic temporomandibular joint
• A history of diagnosed psychological diseases

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Bolu Abant Izzet Baysal University Department of Physiotherapy and Rehabilitation

Bolu, 14300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Neck Pain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• numan yener, phd

  Abant Izzet Baysal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Group allocation was concealed from participants, and outcome assessment was performed by a researcher who was blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof

Model Details: Prospective, double-blinded, parallel, randomized controlled

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 7, 2025
• Study Start: November 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 15, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After publication
• Access Criteria: via mail ramazankurul@ibu.edu.tr

Locations

TU (1)