Quantitative Ultrasound of Trapezius Muscle in Cervical M... | NCT03571178

Studies
Quantitative Ultrasound of Trapezius Muscle in Cervical Myofascial Syndrome

NCT03571178

Sponsor

Marmara University

Status

Unknown status

Last Update Posted

Jun 27, 2018Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Myofascial Pain Syndrome

Interventions

Physical Therapy

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

Jun 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2018Estimated

Primary Completion Date

Feb 2019Estimated

Completion Date

Aug 2019Estimated

First Submitted Date

Jun 16, 2018

First Submission Date that Met QC Criteria

Jun 16, 2018

First Posted Date

Jun 27, 2018Actual

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

Jun 16, 2018

Last Update Posted Date

Jun 27, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

The myofascial points within the trapezius muscle are hypoechogenic regions that can be depicted via ultrasound imaging. In this study we aimed to demonstrate the hypoechogenic regions within the trapezius muscle and to determine if physical therapy modalities change the appearance and size of these areas. We also wanted to explore if the presence of these areas correlate with pain.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental	Patients who will receive physical therapy	Other: Physical Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Physical Therapy	Other	Physical therapy consisting of the application of hotpack, TENS and treatment ultrasound	Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual Analogue Scale	Pain	3 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with myofascial pain syndrome in the cervical region

Exclusion Criteria:

Presence of cervical radiculopathies
Previous history of cervical injusy
Presence of rheumatologic diseases

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ozge Kenis Coskun	Contact	05058294947		ozgekenis@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ozge Kenis Coskun		Istanbul	Kadikoy	34738	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33480607	Derived	Sancar M, Kenis-Coskun O, Gunduz OH, Kumbhare D. Quantitative Ultrasound Texture Feature Changes With Conservative Treatment of the Trapezius Muscle in Female Patients With Myofascial Pain Syndrome. Am J Phys Med Rehabil. 2021 Nov 1;100(11):1054-1061. doi: 10.1097/PHM.0000000000001697.

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases

ID	Term
D013812	Therapeutics
D012046	Rehabilitation