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Completed

NCT Number: NCT04575129

Psychometric Properties of the Turkish Version of S-ROM-Neck

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pamukkale University Hospital

Denizli, 20160, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention will be applied

Other

No intervention will be applied

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

Cross-cultural Adaptation, Reliability, and Validity of Self Administered Neck Mobility Assessment Tool (S-ROM-Neck): Turkish Version

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 5, 2020
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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