Effect of Manual Therapy on Temporomandibular Joint Dysfunction

NCT ID: NCT07210957

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-07-15

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.

Conditions

Temporomandibular Disorder; Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Manual therapy

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.

Group Type: OTHER

Manual Therapy

Intervention Type: 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.

Sham manual therapy

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.

Group Type: SHAM_COMPARATOR

Sham manual therapy

Intervention Type: 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.

Interventions

Manual Therapy

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.

Intervention Type: OTHER

Sham manual therapy

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abant Izzet Baysal University

OTHER

Sponsor Role: lead

Responsible Party

Ramazan KURUL

Assoc. Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

numan yener, phd

Role: PRINCIPAL_INVESTIGATOR

Abant Izzet Baysal University

Locations

Bolu Abant Izzet Baysal University Department of Physiotherapy and Rehabilitation

Bolu, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AIBU-FTR-RK-12

Identifier Type: -

Identifier Source: org_study_id