The Clinical Effects of Myofascial Trigger Points in Disc Replacement With Reduction

Pain Clinical Trial

Official title:

The Effect of Myofascial Trigger Points on Clinical Symptoms, Pain and Limitation of Temporomandibular Joint Function in Disc Displacement With Reduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05187325
• Other study ID #: KAEK/2021.11.309
• Status: Completed
• Start date: December 15, 2021
• Est. completion date: February 17, 2022

Study information

• Verified date: March 2022
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This is a prospective, and controlled trial. 60 participants with myofascial trigger points and disc displacement with reduction and 60 participants with disc displacement with reduction will be included in the study. These two groups will be compared for clinical findings, pain severity and limitation of the temporomadibular function.

Description:

This is a prospective, and controlled trial. 60 participants with myofascial trigger points and disc displacement with reduction and 60 participants with disc displacement with reduction will be included in the study. The participants' ages will be between 18-65 years of both genders.

These two groups will be compared for clinical findings with DC/TMD Axis I- Symptom Questionnaire, pain levels in the last 1 month with DC/TMD Axis II-Graded Chronic Pain Scale, and limitation of the temporomadibular function with DC/TMD Axis II-Jaw Functional Limitation Scale-8.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 17, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18-65 years old of both genders.

• Presence of disc displacement with reduction with/without myofascial trigger points in master muscles.

• Being accepted of the participation in the study.

Exclusion Criteria:

• Lack of cognitive ability to understand test instructions, illiteracy, aphasia, presence of a known psychiatric illness

• Refusal to participate in the study

• Patients under the age of 18 and over the age of 65

• Having other temporomandibular joint disorders other than the diagnosis of RDD and/or myofascial trigger points

Related Conditions & MeSH terms

• Jaw Diseases
• Joint Diseases
• Myofascial Pain Syndromes
• Myofascial Trigger Point Pain
• Pain
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Other:
• no intervention
there is no intervention

Locations

Country	Name	City	State
Turkey	Kanuni Sultan Suleyman Training and Research Hospital	Istanbul	Kucukcekmece

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mouth opening distance	Maximal opening of mouth is described as the greatest distance between incisal edge of maxillary central incisor to the incisal edge of mandibular central incisor, when the mouth is opened as wide as possible painlessly or as the inter incisal distance plus the overbite.	1 day
Primary	bruxism	bruxism is a stereotyped movement disorder characterized by grinding or clenching of the teeth	1 day
Primary	limitation of the movement of the temporomandibular joint	limitation of the movement of the temporomandibular joint	1 day
Primary	temporomandibular joint noises	noises of the temporomandibular joint	1 day
Primary	locking of the temporomandibular joint	locking of the temporomandibular joint	1 day
Primary	Graded Chronic pain Scale v.2.0	Version 2 of the GCPS includes, in addition to the 3 items for pain intensity and 4 items for function, one item for number of days of pain.	1 day
Primary	Jaw Functional Limitation Scale-8	The JFLS was initially developed as an 8-item global scale for overall functional limitation of the masticatory system; based on the resultant items and supporting psychometric data, the instrument was re-developed in order to expand measured constructs to also include masticatory limitation, vertical mobility limitation, and verbal and non-verbal communication limitation.	1 day