NCT05692206

Brief Summary

Chronic neck pain is a common problem in our society. With the Neck Disability Index, we can classify the functional status of individuals with chronic neck pain as "no restriction, mildly limited, moderately limited, severely restricted, completely limited". In this study, the difference between cognitive functions, kinesiophobia and neck awareness between those who have a functional status according to the Neck Disability Index and those whose functional status is "slightly limited-moderately restricted" and those who are "severely limited-totally limited" will be investigated with questionnaires and evaluations. The study will provide information about whether there is a difference between individuals with chronic neck pain regarding cognitive functions, kinesiophobia and neck awareness according to their functional status. Thus, it will contribute to the literature to provide clinicians with awareness about the functionality levels in chronic neck pain and to consider individuals within this framework.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

December 21, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 20, 2023

Completed
24 days until next milestone

Study Start

First participant enrolled

February 13, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2023

Completed
Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

December 21, 2022

Last Update Submit

January 18, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • cognitive functions

    Stroop TBAG test will be applied to evaluate cognitive functions. Stroop TBAG Test; It is designed to measure the perceptual setup, the ability to adjust itself to the desired demand under the influence of distraction, the ability to rule out a habitual behavioral movement, and the focusing skills of individuals. The test consists of 5 separate parts in total. The patient reads the words written in black on the first sheet of paper. The patient reads the words written in color on the second sheet of paper. The patient tells the colors of the circle shapes on the third sheet of paper. The patient simply says the color of the fourth sheet without reading the unrelated words written in color. The patient correctly tells the color of the words printed in a different color from his own color on the fifth paper.

    8 week

  • kinesiophobia

    Tampa Kinesiophobia Scale will be used to measure fear of movement (kinesiophobia). The purpose of developing this scale is to distinguish patients with normal response and high fear of movement. There are 17 questions in the scale and a 4-point Likert scoring is used. After the 4th, 8th, 12th and 16th items are reversed in scoring, a total score is calculated and a minimum of 17 and a maximum of 68 points are obtained. The higher the score on the scale, the greater the fear of movement.

    8 week

  • neck awareness

    The Fremantle Neck Awareness Questionnaire will be used to measure the neck awareness of the individuals participating in the study. The questionnaire asks individuals 9 questions such as how they perceive their neck relative to their body, how they perceive their body position. Likert type assessing individual-specific altered perception (0 = Never/Never feel this way, 1 = I rarely feel this way, 2 = Sometimes, or sometimes I feel this way, 3 = I feel this way often, 4 = I feel this way all or most of the time) it is a simple survey.

    8 week

  • Neck Disability Index

    The Neck Disability Questionnaire consists of 10 questions related to pain intensity, personal care, lifting, reading, concentration, headache, working, driving, sleeping and recreational activities. There are 6 options for each question, ranging from 0 to 5 points. 0 points means no restrictions, 50 points means full apology. A score of 0-4 means no restriction, a score of 5-14 means mildly restricted, a score of 15-24 moderately restricted, 25-34 severely restricted, and 35 and above means completely restricted.

    8 week

Study Arms (2)

according to the neck disability index, mildly and moderately affected

Other: evaluation

According to the neck disability index, severely affected and very severely affected

Other: evaluation

Interventions

Surveys will be administered to the participants. Participants will be given a stroop TBAG test.

According to the neck disability index, severely affected and very severely affectedaccording to the neck disability index, mildly and moderately affected

Eligibility Criteria

Age40 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

According to the neck disability index, those with mild and moderate severity will be determined as the first group, and those who are severely and severely affected will be determined as the second group.

You may qualify if:

  • A score of 24 or higher on the Standardized Minimental Test.
  • Having chronic neck pain problem for the last 6 months.
  • Being between the ages of 40-59.
  • Volunteer to participate in the study.
  • To be able to read and write.

You may not qualify if:

  • To have a score of 0-4 from the Neck Disability Questionnaire.
  • Having undergone musculoskeletal surgery.
  • Having a rheumatic or neurological disease.
  • pregnancy status
  • Having a congenital musculoskeletal disorder.
  • The presence of trauma, infectious pathology or scoliosis affecting the spine.
  • Any visual impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yunus Özkaya

Malatya, Battalgazi, 44050, 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
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

December 21, 2022

First Posted

January 20, 2023

Study Start

February 13, 2023

Primary Completion

April 7, 2023

Study Completion

April 7, 2023

Last Updated

January 20, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations