Neck PainNCT04575129
Psychometric Properties of the Turkish Version of S-ROM-Neck
An observational study of Neck Pain, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2021to 1 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- To have neck pain for at least 3 months.
- Turkish literate individual
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Neck Pain
- Being tested
- No intervention will be applied
- Keywords
- Surveys and Questionnaires, Neck Pain, Range of Motion, Psychometrics
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention will be appliedOther
No intervention will be applied
| Study group | Role | What they receive |
|---|---|---|
| Study Group | No intervention will be applied Receives: Other: No intervention will be applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
S-ROM-Neck
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).
Measured: 5 minutes
Secondary outcomes (3)
Visual Analog Scale
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.
Measured: 2 minutes
Neck Disability Index
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.
Measured: 5 minutes
Neck range of motion (ROM) measurement with inclinometer
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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start15 Jan 2021
- Primary completion15 Aug 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Aslan Telci, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575129
- Sponsor's protocol ID
- S-ROM-Neck
- Status last verified
- Sep 2021
- First submitted
- 30 Sep 2020
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-cultural Adaptation, Reliability, and Validity of Self Administered Neck Mobility Assessment Tool (S-ROM-Neck): Turkish Version
- ClinicalTrials.gov ID
- NCT04575129
- Acronym / sponsor ID
- S-ROM-Neck
- Conditions
- Neck Pain
- Keywords
- Surveys and Questionnaires, Neck Pain, Range of Motion, Psychometrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: No intervention will be appliedNo intervention will be applied |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (2 listed)
- To have neck pain for at least 3 months.
- Turkish literate individual
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention will be appliedNo intervention will be applied | Other | Study Group |
Primary outcome
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).
3 secondary outcomes
Visual Analog Scale
Time frame: 2 minutes
Neck Disability Index
Time frame: 5 minutes
Neck range of motion (ROM) measurement with inclinometer
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Pain, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
S-ROM-Neck (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.