NCT05225571

Brief Summary

Participants between the ages of 18-64 who were diagnosed with cervical myofascial pain syndrome will be included in the study. cervical sagittal parameters, numerical pain rating scale, Bournemouth neck questionnaire and cervical range of motion will be measured and evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
133

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 24, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 4, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2022

Completed
Last Updated

December 27, 2022

Status Verified

December 1, 2022

Enrollment Period

10 months

First QC Date

December 24, 2021

Last Update Submit

December 23, 2022

Conditions

Keywords

sagittal alignmentmyofascial pain syndromeneck disabilitypain intensity

Outcome Measures

Primary Outcomes (4)

  • NRS (Numerical rating scale)

    The Numeric Rating Scale (NRS) is the simplest and most commonly used numeric scale in which the child rates the pain from 0 (no pain) to 10 (worst pain)

    1 day

  • cervical range of motion (degree)

    cervical flexion, extension, lateral flexion and rotation angles are actively evaluated.

    1 day

  • Bournemouth Neck Questionnaire

    Adapted from the Bournemouth Low Back Pain questionnaire developed by Bolton and Humphreys in 2002. The Bournemouth Neck Pain Questionnaire consists of 7 questions in total. Each question scores between 0 and 10. Although the highest score is 70, a high score indicates a high level of disability.

    1 day

  • cervical sagittal parameters

    Parameters to be checked in cervical lateral radiograph; C0-2 and C2-7 lordosis, T1 slope, c2-7 sagittal vertical axis, TS-CL, servical tilt and cranial tilt.

    1 day

Study Arms (1)

cervical myofascial pain syndrome

The participants who diagnosed as cervical myofascial pain syndrome aged 18-64 years. The pain must last at least 3 months.

Other: no intervention

Interventions

there is no any intervention in this study. it is an observational and cross-sectional study.

cervical myofascial pain syndrome

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The participants who aged 18-64 Years , and diagnosed as cervical myofascial pain syndrome.

You may qualify if:

  • Age at 18-64 years
  • Neck pain due to myofascial pain syndrome for more than 3 months
  • Presence of lateral cervical radiograph taken in neutral position in the last 3 months
  • Visible lower border of T1 vertebra on lateral radiographs
  • Absence of other spinal pathologies such as underlying scoliosis, cervical disc herniation, spondylolysis, spondylolisthesis

You may not qualify if:

  • Presence of an organic pathology that will cause neck pain
  • Inability to see the lower border of the T1 vertebra on lateral cervical radiographs and the radiographs not taken in neutral position

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Suleyman TRH

Istanbul, Kucukcekmece, 34303, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Myofascial Pain SyndromesNeck PainPain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Merve Damla Korkmaz

    Kanuni Sultan Suleyman Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 24, 2021

First Posted

February 4, 2022

Study Start

September 1, 2021

Primary Completion

July 10, 2022

Study Completion

October 10, 2022

Last Updated

December 27, 2022

Record last verified: 2022-12

Locations