Factors Affecting Patients With Myofascial Temporomandibular Disorders

Completed

• Conditions: Headache; Sleep Disturbance; Myofascial Temporomandibular Disorder; Bruxism, Sleep; Jaw Spasm
• Interventions: Other: Scales and indexes

• Registration Number: NCT04842136
• Lead Sponsor: Hasan Kalyoncu University

Brief Summary

The aim of the study was to assess and compare the relationship between jaw function, neck disability, sleep quality, fatigue, and headache in patients with myofascial Temporomandibular Disorder (TMD) with Sleep Bruxism (SB) and without (non-SB).

Detailed Description

The study was conducted on TMD patients who were willing to participate in the study between January and December 2020.

The case-control study included patients diagnosed with myofascial TMD by dental practitioners at regional hospitals referred for physiotherapy. Total of 200 myofascial TMD patients, comprising 91 identified as SB and 109 as non-SB were included in the study.

The Jaw Function Limitations Scale (JFLS), Neck Disability Index (NDI), Pittsburgh Sleep Quality Index (PSQI), Fatigue Severity Scale (FSS), and Headache Impact Test-6 (HIT-6) scales and indexes were used for both groups.

The effect of Sleep Bruxism (SB) on jaw function, neck problems, sleep quality, fatigue, and tension headache were evaluated.

The interactions of these factors and the importance of taking SB into consideration when evaluating and treating patients with TMD were examined.

Study Timeline

• Study Start: 2020-01-13
• Primary Completion: 2020-12-18
• Study Completion: 2021-02-25
• Status Verified: 2021-04
• Study First Submitted: 2021-04-08
• Study First Submitted QC: 2021-04-08
• Last Update Submitted: 2021-04-08
• Study First Posted: 2021-04-13
• Last Update Posted: 2021-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• diagnosis of myofascial TMD according to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
• pain for more than 6 months
• no therapeutic interventions reported for TMD or the neck in the last 6 months
• intellectual capacity to provide informed consent

Exclusion Criteria

• not meeting the DC/TMD criteria
• diagnosis of psychiatric disease
• history of surgery related to the cervical region and/or TMJ
• cervical and/or TMJ malignancy
• trauma history
• proven specific pathologies such as fracture, or rheumatoid disease
• history of facial paralysis
• pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Myofascial Temporomandibular Disorder (TMD) with Sleep Bruxism (SB)	Scales and indexes	Patients with Myofascial TMD and with sleep bruxism with the diagnosis of regular or frequent teeth grinding sounds during the sleep, and one or more following clinical signs, such as jaw muscle pain or fatigue on waking up in the morning, temporal headache, hypertrophy of the masseter muscle, abnormal tooth wear, and/or jaw locking were included in the group.
Myofascial Temporomandibular Disorder (TMD) without Sleep Bruxism (SB)	Scales and indexes	Patients with Myofascial TMD without sleep bruxism were included in the group.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale	Baseline	The severity of pain in muscles was measured in centimeters using a 0-10 Visual Analogue Scales (VAS). The scale ranges from 0 = "no pain at all" to 10 = "intolerable pain"
Fatigue Severity Scale	Baseline	The effect of fatigue on functional and behavioral aspects was evaluated by the Fatigue Severity Scale (FSS). The total score is calculated as the average of the 9 item scores -the lower the total score, the lower the fatigue level. A cut-off value of ≥4 has been defined for fatigue
Headache Impact Test	Baseline	The Headache Impact Test-6 (HİT-6) was used to assess the headache. The 6 items scale evaluating the frequency, the degree of restriction to daily life and social life, and changes in the mood because of headache. The total score 50-59 reflects important impact, and scores ≥60 indicate severe impact.
Neck Disability Index	Baseline	Neck problems were assessed with Neck Disability Index (NDI). It is a scale of 10 sections with total points ranging from 0-50. Higher scores indicate severe pain, and a score of ≥5 indicates a neck disorder.
Jaw Functional Limitation Scale	Baseline	The Jaw Functional Limitation Scale-20 was used to assess jaw function in the masticatory system. The scale consists of a total of 20 items with three constructs. Each item is scored from 0-10, with 0 indicating no restriction and 10, severe restriction. A total of ≥5 indicates jaw function limitation.
Pittsburgh Sleep Quality Index	Baseline	The sleep quality was evaluated using the Pittsburgh Sleep Quality Index (PSQI). The scale comprises a total of 24 items in 7 sub-scales. The total points of the 19 items that score from 0-21, with a total of ≥5 indicating poor sleep quality.

Trial Locations

Locations (2)

Abdulkadir Konukoglu Healthy Life Center; 🇹🇷 Gaziantep, Turkey

Umut Rehabilitation Center; 🇹🇷 Şanlıurfa, Turkey