NCT03571178

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 27, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

June 27, 2018

Status Verified

June 1, 2018

Enrollment Period

6 months

First QC Date

June 16, 2018

Last Update Submit

June 16, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale

    Pain

    3 weeks

Study Arms (1)

Treatment

EXPERIMENTAL

Patients who will receive physical therapy

Other: Physical Therapy

Interventions

Physical therapy consisting of the application of hotpack, TENS and treatment ultrasound

Treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with myofascial pain syndrome in the cervical region

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ozge Kenis Coskun

Istanbul, Kadikoy, 34738, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Central Study Contacts

Ozge Kenis Coskun

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2018

First Posted

June 27, 2018

Study Start

August 1, 2018

Primary Completion

February 1, 2019

Study Completion

August 1, 2019

Last Updated

June 27, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations