Neck Pain Clinical Trial
Official title:
Cross-cultural Adaptation, Reliability, and Validity of Self Administered Neck Mobility Assessment Tool (S-ROM-Neck): Turkish Version
Verified date | September 2021 |
Source | Pamukkale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | September 1, 2021 |
Est. primary completion date | August 15, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Pamukkale University Hospital | Denizli |
Lead Sponsor | Collaborator |
---|---|
Pamukkale University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | 5 minutes | |
Secondary | 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. | 2 minutes | |
Secondary | 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. | 5 minutes | |
Secondary | 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. | 10 minutes |
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