Post-Isometric Relaxation in Temporomandibular Disorders

NCT07130279 | Not Yet Recruiting

• 1 other identifier: TME-PIR-2024-01
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Temporomandibular Joint Disorders; Myofascial Pain Syndromes; Mandibular Dysfunction

Keywords

Temporomandibular Joint Dysfunction; Post-Isometric Relaxation; range of motion

Outcome Measures

Primary Outcomes (7)

• Change in mandibular depression (mouth opening)

  The distance between the upper and lower central incisors during maximal mouth opening will be measured in millimeters using a caliper.

  Baseline and after 6 weeks of intervention

• Change in cervical range of motion

  Cervical range of motion will be measured in degrees using a goniometer. Movements assessed will include flexion, extension, right and left lateral flexion, and right and left rotation.

  Baseline and after 6 weeks of intervention

• Change in mandibular lateral deviation (right and left)

  The horizontal movement of the lower jaw to the right and left will be measured in millimeters using a caliper.

  Baseline and after 6 weeks of intervention

• Change in mandibular protrusion

  The anterior translation of the mandible will be measured in millimeters using a caliper. Outcome Measure: Change in head anterior tilt - chin-sternum distance

  Baseline and after 6 weeks of intervention

• Change in head anterior tilt - chin-sternum distance

  The vertical distance from the midpoint of the chin to the superior border of the sternum will be measured in centimeters with a measuring tape.

  Baseline and after 6 weeks of intervention

• Change in head anterior tilt - occiput-wall distance

  The distance between the occiput and the wall will be measured in centimeters while the participant stands in a natural posture against the wall.

  Baseline and after 6 weeks of intervention

• Change in thoracic kyphosis index

  Thoracic kyphosis will be evaluated using a flexicurve ruler to measure curvature from C7 to T12. The thoracic kyphosis index will be calculated as (thoracic width / thoracic length) × 100.

  Baseline and after 6 weeks of intervention

Study Arms (2)

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

EXPERIMENTAL

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.

Behavioral: Postural Exercises + Post-Isometric Relaxation (PIR) Technique; Behavioral: Postural Exercises

Control Arm: Postural Exercises Only

ACTIVE COMPARATOR

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.

Behavioral: Postural Exercises

Interventions

Postural Exercises + Post-Isometric Relaxation (PIR) Technique 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.

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

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

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanem ŞENER: lead

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Myofascial Pain Syndromes

Interventions

Methods

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Sanem ŞENER

  Zonguldak Bulent Ecevit University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanem ŞENER

CONTACT

+90 5535918396; sanemsener@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is a single-masked trial in which the outcomes assessor is blinded to group allocation. The assessor responsible for measuring cervical range of motion, mandibular mobility, head anterior tilt, and thoracic kyphosis index will not be informed of the participants' assigned intervention group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomly assigned into two parallel groups: the experimental group will receive postural exercises combined with the Post-Isometric Relaxation (PIR) technique, while the control group will receive postural exercises only. Both groups will follow the intervention protocol three times per week for six weeks, with no crossover between groups.

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 19, 2025
• Study Start: August 11, 2025
• Primary Completion: September 22, 2025
• Study Completion: September 25, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share