NCT05359523

Brief Summary

Pathologies in the trapezius muscle and rhomboid muscle are important in the course and treatment of the disease in patients with myofascial pain syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

May 1, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 4, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

3 years

First QC Date

April 27, 2022

Last Update Submit

January 5, 2025

Conditions

Myofascial Pain Syndrome

Outcome Measures

Primary Outcomes (2)

  • Trapezius muscle and rhomboid muscle thickness

    Trapezius and rhomboid muscle thickness and fascial thickness measurement will be made by ultrasonography at rest.

    20 minute

  • fascial sliding

    Measurements of the amount of slip measured during the movement of the fascial structures during shoulder and arm movements. ultrasonography M-mode measurements Arm from the shoulder joint, cervical lateral flexion, cervical anterior flexion, shoulder elevation

    20 minute

Secondary Outcomes (3)

  • VAS

    6 th month

  • NPDS

    6th month

  • SF-12

    6th month

Study Arms (2)

Patients diagnosed with myofascial pain syndrome

ACTIVE COMPARATOR

Ultrasound measurements will be made while the upper back is at rest and during arm movements.

Device: Ultrasonographic measurements of the trapezius and rhomboid muscle and fasciaOther: fascia injection

Healthy volunteers

ACTIVE COMPARATOR

Ultrasound measurements will be made while the upper back is at rest and during arm movements.

Device: Ultrasonographic measurements of the trapezius and rhomboid muscle and fascia

Interventions

Ultrasonographic measurements of the trapezius and rhomboid muscle and fasciaDEVICE

B mode measurements Trapezius and rhomboid muscle thickness and fascial thickness measurement M mode measurements Abduction at 90 and 180 degrees Forward flexion at 90 and 180 degrees

Healthy volunteersPatients diagnosed with myofascial pain syndrome
fascia injectionOTHER

Under ultrasound guidance, a local anesthetic and steroid mixture will be injected into the fascia between the trapezius muscle and the rhomboid muscle.

Patients diagnosed with myofascial pain syndrome

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • myofascial pain syndrome

You may not qualify if:

  • Cervical radiculopathy
  • Fibromyalgia
  • Shoulder joint disease,
  • Peripheral and central nervous system disease
  • Polyneuropathy,
  • Inflammatory rheumatic disease,
  • Malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Burcu Metin Ökmen

Nilufer, Bursa, 16110, Turkey (Türkiye)

Location

Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

Bursa, 16320, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Study Officials

  • Korgün Ökmen, Assoc. PhD.

    Bursa Yuksek Ihtisas Training and Research Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Phd.M.D

Study Record Dates

First Submitted

April 27, 2022

First Posted

May 4, 2022

Study Start

May 1, 2021

Primary Completion

May 1, 2024

Study Completion

August 1, 2024

Last Updated

January 7, 2025

Record last verified: 2025-01

Locations

TU(2)