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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05225571
Other study ID # KAEK/2021.05.146
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date October 10, 2022

Study information

Verified date December 2022
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

It is an observational, cross-sectional study. Participants between the ages of 18-64 who were diagnosed with cervical myofascial pain syndrome, who applied to the Physical Medicine and Rehabilitation Clinic of Kanuni Sultan Süleyman Training and Research Hospital with neck pain for more than 3 months will be included. The pain level of the participants will be evaluated with the numerical pain rating scale, the cervical range of motion and the disability level with the Bournemouth neck questionnaire. C0-2 cervical lordosis angle, C2-C7 cervical lordosis angle, cervical sagittal vertical axis (cSVA), T1 slop, T1 slop - cervical lordosis angle (TS-CL), cervical tilt, thoracic inlet angle (TIA) and Cranial tilt measurement will be performed by using Surgimap software program. The relationship between the level of pain and disability, and cervical sagittal parameters will be evaluated.


Recruitment information / eligibility

Status Completed
Enrollment 133
Est. completion date October 10, 2022
Est. primary completion date July 10, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Intervention

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

Locations

Country Name City State
Turkey Kanuni Sultan Suleyman TRH Istanbul Kucukcekmece

Sponsors (1)

Lead Sponsor Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary cervical range of motion (degree) cervical flexion, extension, lateral flexion and rotation angles are actively evaluated. 1 day
Primary 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
Primary 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
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