Post-Isometric Relaxation in Temporomandibular Disorders

NCT ID: NCT07130279

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-11
• Study Completion Date: 2025-09-25

Brief Summary

This planned randomized, single-blind clinical trial will investigate the effects of adding the Post-Isometric Relaxation (PIR) technique to a standard postural exercise program in individuals with moderate to severe temporomandibular joint dysfunction (TMD). Forty volunteers aged 18-25 years will be recruited and randomly assigned to either an experimental group (postural exercises + PIR) or a control group (postural exercises only). The intervention will be delivered three times per week for six weeks. Primary outcomes will include cervical range of motion, mandibular mobility, head anterior tilt, and thoracic kyphosis index, measured before and after the intervention. The study aims to determine whether PIR provides additional benefits to standard postural exercises in improving jaw and neck function and postural alignment in young adults with TMD.

Detailed Description

Temporomandibular joint dysfunction (TMD) is a common musculoskeletal condition characterized by jaw pain, limited mouth opening, and joint sounds, often accompanied by postural deviations such as forward head posture and thoracic kyphosis. Conservative treatments, including postural exercises and manual therapy, are recommended to improve jaw and neck function and reduce symptoms.

The Post-Isometric Relaxation (PIR) technique is a manual therapy method that uses gentle isometric contractions followed by passive stretching to reduce muscle tension and increase mobility. While PIR has been shown to improve masticatory muscle function, its combined use with postural exercises in TMD management has not been fully evaluated.

In this planned study, forty volunteers aged 18-25 years with moderate or severe TMD (diagnosed using the Fonseca Anamnestic Questionnaire) will be recruited. Participants will be randomly assigned into two groups:

Experimental group: Postural exercise program + PIR technique

Control group: Postural exercise program only

The postural exercise program will include strengthening, stretching, and mobility exercises for the cervical and thoracic regions, performed three times per week for six weeks. In the experimental group, the PIR technique will be applied to jaw muscles according to a standardized protocol.

Outcome measures will include:

Cervical range of motion (flexion, extension, lateral flexion, rotation) measured with a goniometer

Mandibular mobility (depression, lateral deviation, protrusion) measured with a caliper

Head anterior tilt (chin-sternum distance, occiput-wall distance)

Thoracic kyphosis index measured with a flexicurve

Assessments will be conducted before the intervention and after the six-week program. The primary hypothesis is that the addition of PIR to postural exercises will produce greater improvements in cervical and mandibular mobility than postural exercises alone.

This trial is expected to provide new evidence for combining manual therapy with exercise in the management of TMD in young adults and may help guide future rehabilitation strategies.

Conditions

Temporomandibular Joint Disorders; Myofascial Pain Syndromes; Mandibular Dysfunction

Study Design

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

Study Groups

Experimental Arm: Postural Exercises + Post-Isometric Relaxation (PIR) Technique

Participants in this group will perform a standardized postural exercise program targeting cervical and thoracic regions, three times per week for six weeks. In addition, the Post-Isometric Relaxation (PIR) technique will be applied to the jaw muscles during each session, following a standardized manual therapy protocol to reduce muscle tension and improve mandibular mobility.

Group Type: EXPERIMENTAL

Postural Exercises + Post-Isometric Relaxation (PIR) Technique

Intervention Type: BEHAVIORAL

Participants will perform a standardized postural exercise program (strengthening, stretching, and mobility exercises for the cervical and thoracic regions) three times per week for six weeks. In addition, the Post-Isometric Relaxation (PIR) technique will be applied to jaw muscles during each session to reduce muscle tension and improve mandibular mobility.

Postural Exercises

Intervention Type: BEHAVIORAL

Participants will perform a standardized postural exercise program designed to improve cervical and thoracic mobility and postural alignment. The program will include strengthening, stretching, and mobility exercises targeting the cervical spine, thoracic spine, and related musculature. Each session will last approximately 30-40 minutes and will be conducted three times per week for six weeks under the supervision of a trained therapist.

Control Arm: Postural Exercises Only

Participants in this group will perform the same standardized postural exercise program targeting cervical and thoracic regions, three times per week for six weeks, without the addition of the PIR technique.

Group Type: ACTIVE_COMPARATOR

Postural Exercises

Intervention Type: BEHAVIORAL

Participants will perform a standardized postural exercise program designed to improve cervical and thoracic mobility and postural alignment. The program will include strengthening, stretching, and mobility exercises targeting the cervical spine, thoracic spine, and related musculature. Each session will last approximately 30-40 minutes and will be conducted three times per week for six weeks under the supervision of a trained therapist.

Interventions

Postural Exercises + Post-Isometric Relaxation (PIR) Technique

Participants will perform a standardized postural exercise program (strengthening, stretching, and mobility exercises for the cervical and thoracic regions) three times per week for six weeks. In addition, the Post-Isometric Relaxation (PIR) technique will be applied to jaw muscles during each session to reduce muscle tension and improve mandibular mobility.

Intervention Type: BEHAVIORAL

Postural Exercises

Participants will perform a standardized postural exercise program designed to improve cervical and thoracic mobility and postural alignment. The program will include strengthening, stretching, and mobility exercises targeting the cervical spine, thoracic spine, and related musculature. Each session will last approximately 30-40 minutes and will be conducted three times per week for six weeks under the supervision of a trained therapist.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age between 18 and 25 years
• Diagnosis of moderate or severe temporomandibular joint dysfunction (TMD) according to the Fonseca Anamnestic Questionnaire
• Presence of TMD symptoms for at least 6 months
• No TMD treatment received within the last 6 months
• Presence of chewing muscle pain for at least 6 months
• Able and willing to participate in the study and follow the exercise program
• Signed informed consent form

Exclusion Criteria

• History of jaw or facial trauma within the past year
• History of temporomandibular joint surgery
• Presence of systemic rheumatologic, neurological, or musculoskeletal disorders affecting the jaw, neck, or spine
• Pregnancy
• Current participation in another clinical trial
• Inability to perform the exercise program due to medical or physical limitations
• Refusal to provide informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanem ŞENER

OTHER

Sponsor Role: lead

Responsible Party

Sanem ŞENER

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sanem ŞENER

Role: PRINCIPAL_INVESTIGATOR

Zonguldak Bulent Ecevit University

Central Contacts

Sanem ŞENER

Role: CONTACT

sanemsener@yahoo.com

+90 5535918396

Other Identifiers

TME-PIR-2024-01

Identifier Type: -

Identifier Source: org_study_id