NCT04575129

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

January 15, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2021

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

September 5, 2021

Status Verified

September 1, 2021

Enrollment Period

7 months

First QC Date

September 30, 2020

Last Update Submit

September 3, 2021

Conditions

Keywords

Surveys and QuestionnairesNeck PainRange of MotionPsychometrics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Visual Analog Scale

    2 minutes

  • Neck Disability Index

    5 minutes

  • Neck range of motion (ROM) measurement with inclinometer

    10 minutes

Study Arms (1)

Study Group

No intervention will be applied

Other: No intervention will be applied

Interventions

No intervention will be applied

Study Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic

You may qualify if:

  • To have neck pain for at least 3 months.
  • Turkish literate individual

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University Hospital

Denizli, 20160, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 30, 2020

First Posted

October 5, 2020

Study Start

January 15, 2021

Primary Completion

August 15, 2021

Study Completion

September 1, 2021

Last Updated

September 5, 2021

Record last verified: 2021-09

Locations