Effect of Manual Therapy on Temporomandibular Joint Dysfunction

Not Applicable

Completed

• Conditions: Temporomandibular Disorder; Neck Pain

• Registration Number: NCT07210957
• Lead Sponsor: Abant Izzet Baysal University

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.

Detailed Description

TMD affects approximately one-quarter of the population and is characterized by pain, restricted movement, and impaired mandibular function. Etiology is multifactorial, including occlusal issues, trauma, bruxism, stress, and postural alterations. Bruxism in particular contributes to repetitive loading and hypertonia of the masticatory and cervical muscles, potentially influencing global posture. Current treatment approaches range from occlusal splints and surgery to conservative physiotherapy, manual therapy, and exercise. While manual therapy may reduce pain and restore mobility through techniques such as joint mobilization, myofascial release, and muscle inhibition, exercise supports improvements in strength, endurance, coordination, and joint stability. Evidence suggests that combined approaches may provide additive benefits. This trial will compare manual therapy and therapeutic exercise interventions in patients with TMD over six weeks. Objective outcomes will include ultrasound-based muscle thickness, pain pressure threshold, mandibular range of motion, pain intensity, and mandibular function. Anxiety levels will also be assessed using validated questionnaires. The primary hypothesis is that manual therapy will produce greater improvements across these measures compared to exercise.

Study Timeline

• Study Start: 2024-11-01
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-15
• Status Verified: 2025-09
• Study First Submitted: 2025-09-30
• Study First Submitted QC: 2025-09-30
• Last Update Submitted: 2025-09-30
• Study First Posted: 2025-10-07
• Last Update Posted: 2025-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Ultrasound Assessment	Baseline, sixth week	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.

Secondary Outcome Measures

Name	Time	Method
Pain Pressure Threshold	Baseline, sixth week	A handheld algometer (1 cm² probe tip, 0-40 kg/cm² range, 0.1 kg increments) will be applied perpendicularly to the masseter, temporalis, upper trapezius, suboccipital muscles, and the C5 facet joint bilaterally. Participants will signal at first pain. Three measurements per site will be taken at 30-second intervals; the mean value (kg/cm²) will be used.
Maximum Mouth Opening and Lateral Excursion	Baseline, sixth week	Measured in millimeters using a manual ruler between the upper and lower central incisors. Maximum unassisted opening will be recorded in supine. For lateral excursion, participants will move the mandible to the right and left as far as possible; distances will be recorded for each side. Pain or discomfort will be noted.
Mandibular Function Scale	Baseline, sixth week	Self-report questionnaire with two parts: functional activities (speaking, smiling, chewing, etc.) and nutrition (difficulty with oral feeding). Each item is scored 0 (no difficulty) to 4 (severe difficulty). Higher total scores indicate greater dysfunction.
State-Trait Anxiety Inventory	Baseline, sixth week	Consists of 40 items: 20 assessing state anxiety and 20 assessing trait anxiety. Each item is scored 1-4, giving subscale totals of 20-80. Higher scores indicate higher anxiety.
Generalized Anxiety Disorder Scale	Baseline, sixth week	A 7-item self-report questionnaire assessing generalized anxiety over the past 2 weeks. Each item is scored 0 (not at all) to 3 (nearly every day). Total score ranges 0-21; scores 5, 10, and 15 represent cut-offs for mild, moderate, and severe anxiety.

Trial Locations

Locations (1)

Bolu Abant Izzet Baysal University Department of Physiotherapy and Rehabilitation; Bolu, Turkey (Türkiye)