Distribution of Trigger Points in Patient Who Have Myofas... | NCT03962556

Studies
Distribution of Trigger Points in Patient Who Have Myofascial Pain Disorder

NCT03962556

Sponsor

Necmettin Erbakan University

Status

Unknown status

Last Update Posted

Aug 20, 2019Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Myofascial Pain

Interventions

bimanual palpation

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 15, 2018Actual

Primary Completion Date

Jan 15, 2020Estimated

Completion Date

Apr 15, 2020Estimated

First Submitted Date

Feb 19, 2019

First Submission Date that Met QC Criteria

May 23, 2019

First Posted Date

May 24, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2019

Last Update Posted Date

Aug 20, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Funda Bastürk, Research assistant in Oral and Maxillofacial surgery, Necmettin Erbakan UniversityPrincipal Investigator

Lead Sponsor

Necmettin Erbakan UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Myofascial pain alone covers 45.3% of the diagnosis of TMJ. It is defined as palpation sensitivity and regional muscle pain. Clinically muscle pain connects to myofascial trigger points.These trigger points are hypersensitive points located in a tense band of the skeletal muscle, which can be described, causing provoked or spontaneous pain. They are divided into two as active and latent. Those who cause spontaneous pain are active, and those who provoke pain are considered latent.Spasm in the chewing muscles with myofascial pain reduces the patient's pain threshold and quality of life.

Therefore, patients with spasm and TMJ pain in the masticatory muscles should be examined for head and neck muscles, the presence of myofascial trigger points should be determined and the head and neck muscles should be included in physical therapy.

The aim of this study was to determine the presence of myofascial trigger points in patients presenting with pain in the masticatory muscles and TMJ region, and to determine the relationship between the presence of trigger point and the degree of pain.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non-Trigger Point			Other: bimanual palpation
Trigger Point			Other: bimanual palpation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bimanual palpation	Other	bimanual palpation....i..	Non-Trigger Point Trigger Point

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
masticatory and cervical muscles examination for determining trigger points	detecting the trigger point (yes or no), determining the number of trigger points and determining the region on the muscle	first day visit
visual analog scale for pain (VAS)	scale to find pain amount , pain scores from 0 to 10 will be taken from patients and higher scores indicate worse pain,all of patient's mean pain score to be determined.	first day visit

Secondary Outcomes

Measure	Description	Time Frame
prevalence of trigger points in facial pain disorder patients	to compare pain scores of patients with and without trigger point,the distribution of trigger points on the masticatory and cervical muscles	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Will be conducted in volunteers who applied to our clinic with complaint of TMJ

Exclusion Criteria:

Diagnosed rheumatoid diseases and fibromyalgia.
Psychiatric drug users.
Patients who use muscle relaxants.
TME pathology

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Will be conducted in volunteers who applied to our clinic with complaint of TMJ

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Funda Basturk	Contact	+905531906023		dtfunda.basturk@gmail.com

Overall Officials

Name	Affiliation	Role
Kubilay Işık	Necmettin Erbakan University/Dentistry Faculty	Study Chair
Dilek Menziletoğlu	Necmettin Erbakan University/Dentistry Faculty	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Necmettin Erbakan University/Dentistry Faculty	Recruiting	Konya			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005157	Facial Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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