- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04575129
Psychometric Properties of the Turkish Version of S-ROM-Neck
September 3, 2021 updated by: Emine Aslan Telci, Pamukkale University
Cross-cultural Adaptation, Reliability, and Validity of Self Administered Neck Mobility Assessment Tool (S-ROM-Neck): Turkish Version
Patient-reported joint motion assessment tools have been developed and applied successfully in several joints of the body.
"The Self Administered Neck Mobility Assessment Tool (S-ROM-Neck)" questionnaire was developed by Langenfeld et al in 2018.
With this questionnaire, the clinicians are able to evaluate the neck joint motion perception of the patients, subjectively.
There is no Turkish version of the questionnaire.
The aim of our study is to develop the Turkish version of the S-ROM-Neck questionnaire, to analyze its cultural adaptation, and to reveal its validity and reliability.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Neck pain leads to a decreased range of motion in the cervical spine, bringing along functional losses.
As a result, this situation is associated with many disabilities.
Evaluation of neck joint motion is essential in patients with chronic neck pain.
It is used to evaluate the neck pain level and functional deficit level of the patient.
In this way, it is possible to evaluate the effectiveness of the treatment applied to the patient during the rehabilitation process.
Generally, this evaluation can be made and interpreted by an experienced clinician.
However, patient perception provides a better understanding of patients' needs and problems by converting clinical data into a patient-centered measure.
Moreover, the patient's perspective can add valuable information to the examination by creating a holistic picture of the patient's problems, possible needs, and expectations.
In 2018, the "Self Administered Neck Mobility Assessment Tool (S-ROM-Neck)" survey was developed by Langenfeld et al.
With this questionnaire, developers purposed to evaluate the neck joint motion perception of the patients, subjectively.
There is no Turkish version of the questionnaire.
The aim of our study is to develop the Turkish version of the S-ROM-Neck questionnaire, to analyze its cultural adaptation, and to reveal its validity and reliability.
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Denizli, Turkey, 20160
- Pamukkale University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Primary care clinic
Description
Inclusion Criteria:
- To have neck pain for at least 3 months.
- Turkish literate individual
Exclusion Criteria:
- Operation history due to neck pain problems
- Individuals diagnosed with tumor, infection, ankylosing spondylitis, rheumatoid arthritis or inflammatory diseases, fracture, cauda equina syndrome
- Pregnancy
- Individuals who do not give consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Study Group
No intervention will be applied
|
No intervention will be applied
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
S-ROM-Neck
Time Frame: 5 minutes
|
The scale includes six questions that target the primary movements of the neck joint (i.e.
flexion, extension, rotation, and lateral flexion).
Patients are asked to actively perform each neck movement and then rate the restriction they perceive during movement.
This is done for each of the 6 directions of motion.
Perceived restriction may be due to pain, stiffness, and/or tension.
S-ROM-Neck has a structure scored with a visual analog scale (VAS).
The left side contains the words "none" to indicate severe ROM restriction and the right side "as far as I want" to indicate maximum ROM.
Explanatory pictures accompany each question.
The total score is calculated by adding individual scores (minimum score [600] = no restriction; maximum score [0] = total restriction).
|
5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale
Time Frame: 2 minutes
|
It is scored between 0 and 10.
While 0 indicates no pain, 10 indicates the most severe pain.
With this scale, which is frequently used in individuals with chronic low back pain, the resting and activity pain of the individuals will be questioned.
|
2 minutes
|
|
Neck Disability Index
Time Frame: 5 minutes
|
The Neck Disability Index consists of 10 sections: pain intensity, personal care, weight lifting, reading, headaches, concentration, work-life, driving, sleep and leisure activities.
Each segment has a value ranging from zero (positive case) to five points (negative state).
The total score on the Neck Disability Index ranges from zero to 50, and the high score corresponds to high disability.
|
5 minutes
|
|
Neck range of motion (ROM) measurement with inclinometer
Time Frame: 10 minutes
|
Cervical region flexion, extension, lateral flexion and rotation movements will be evaluated with a Baseline Bubble Inclinometer.
The inclinometer is a valid and reliable method for evaluating the cervical range of motion (14).
While evaluating the flexion, extension and lateral flexion movements in the cervical region with the inclinometer, it was placed at the top of the head as the pivot point and the participant will be asked to perform the movement to the endpoint and return to the previous position.
For rotation movement, the inclinometer will be placed on the participant's forehead in the supine position, and rotation movement will be requested from the patient.
The value measured in the inclinometer will be recorded.
Each move will be evaluated 3 times separately and its average will be noted.
|
10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 15, 2021
Primary Completion (ACTUAL)
August 15, 2021
Study Completion (ACTUAL)
September 1, 2021
Study Registration Dates
First Submitted
September 30, 2020
First Submitted That Met QC Criteria
September 30, 2020
First Posted (ACTUAL)
October 5, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 5, 2021
Last Update Submitted That Met QC Criteria
September 3, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S-ROM-Neck
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neck Pain
-
Hochschule OsnabruckNot yet recruitingNeck Pain | Chronic Neck Pain | Neck Disability | Neck Pain Musculoskeletal | Neck Disease
-
Istanbul University - CerrahpasaRecruitingNonspecific Neck Pain | Neck Pain MusculoskeletalTurkey (Türkiye)
-
Universitat Internacional de CatalunyaNot yet recruitingChronic Neck Pain | Non-specific Neck PainSpain
-
The Hong Kong Polytechnic UniversityNot yet recruitingChronic Neck Pain | Neck Pain Treatment | Neck Pain ChronicHong Kong
-
Benha UniversityCompletedNeck Pain | Mechanical Neck Pain | Pain Threshold | Cervical Pain, Posterior | Neck Pain Musculoskeletal | Extracorporeal Shock Wave TherapyEgypt
-
University of LahoreCompletedNeck Pain | Mechanical Neck Pain | Mobilization | Neck Pain Musculoskeletal | Proprioceptive Neuromuscular FacilitationPakistan
-
Hacettepe UniversityRecruitingNeck Pain | Cervical Pain | Neck Pain, Posterior | Neck Muscle Issue | Cervical Pain, PosteriorTurkey
-
Fatih TekinPamukkale UniversityCompletedChronic Neck Pain | Persistent Neck Pain | Neuroscience ApproachTurkey
-
Hacettepe UniversityNot yet recruitingChronic Neck PainTurkey (Türkiye)
-
Riphah International UniversityCompletedChronic Neck PainPakistan
Clinical Trials on No intervention will be applied
-
Gazi UniversityRecruiting
-
Beijing Friendship HospitalActive, not recruiting
-
Babes-Bolyai UniversityThe Executive Agency for Higher Education, Research, Development and Innovation...Enrolling by invitationEmotional ResilienceRomania
-
Babes-Bolyai UniversityThe Executive Agency for Higher Education, Research, Development and Innovation...Completed
-
Ankara Yildirim Beyazıt UniversityCompleted
-
Beijing Friendship HospitalKaiLuan General HospitalRecruitingBrain Diseases | HypertensionChina
-
Ataturk UniversityNot yet recruitingStroke | Rehabilitation | Mirror Movement Therapy
-
Inonu UniversityNot yet recruitingStroke | Quality of Life | Neglect, Hemispatial | Upper Extremity Function | Motor ımargery | Daily Life Activity
-
Imperial College LondonCompleted
-
Kutahya Health Sciences UniversityRecruitingDisease Management | Coronary Arterial Disease (CAD) | NURSİNG | LIFE SATISFACTIONTurkey (Türkiye)