NCT04201379

Brief Summary

Pain, muscle spasm, loss of muscle strength and impaired posture adversely affect the daily life activities and quality of life of neck pain patients.However, the quality of life; It is a multifaceted concept that includes not only the age, sex, marital status, educational status and duration of pain, but also the number of children, BMI, depression, sleep quality, pain-related inadequacy and fatigue. Therefore, considering all these; quality of life; The aim of our study was to determine the factors affecting the quality of life in nonspesific neck patients with the effect that the determinants affecting physical, physical role difficulty, pain, general health, vitality, social function, emotional role difficulty and mental health may be different.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

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

Study Start

First participant enrolled

September 30, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 17, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2020

Completed
Last Updated

April 30, 2020

Status Verified

January 1, 2019

Enrollment Period

6 months

First QC Date

November 28, 2019

Last Update Submit

April 29, 2020

Conditions

Keywords

chronicneckpain

Outcome Measures

Primary Outcomes (8)

  • DETERMINING FACTORS AFFECTING THE QUALITY OF LIFE

    to reported determining factors affecting their quality of life Short form-SF36 .All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible. Aggregate scores are compiled as a percentage of the total points possible, using the RAND scoring table (STEP I chart). The scores from those questions that address each specific area of functional health status (STEP II chart) are then averaged together, for a final score within each of the 8 dimensions measured. (eg pain, physical functioning etc.)

    27 february 2020

  • IS PAIN DETERMINING THE QUALITY OF LIFE

    MCMcGill Pain Questionnaire will be used to report pain.The McGill Pain Questionnaire (MPQ) is a three-part pain assessment tool that measures several dimensions of the patient's pain experience. The first part consists of an anatomic drawing of the human form on which the patient marks where his or her pain is located. The second part of the MPQ is a VDS that allows the patient to record the intensity level of his or her current pain experience. The third part of the MPQ is a pain verbal descriptor inventory consisting of 72 descriptive adjectives. The patient is asked to review this list of pain descriptors and circle the ones that serve to best describe his or her current pain experience. Each part or dimension of the MPQ is individually scored and a cumulative total score is also recorded.

    27 february 2020

  • IS PAIN INTENSITY DETERMINING THE QUALITY OF LIFE

    Visual Analog Score for pain, Physicians Global Assessment to measure quality of life.The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme .r pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \[100-mm scale\])

    27 february 2020

  • IS SLEEP QUALİTY DETERMINING THE QUALITY OF LIFE

    te report the effect of sleep quality Pitsburgh Sleep Quality Index will be used. The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in the older adult. It differentiates "poor" from "good" sleep by measuring seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month. The client self rates each of these seven areas of sleep. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of "5"or greater indicates a "poor" sleeper

    27 february 2020

  • IS FATIGUE DETERMINING THE QUALITY OF LIFE

    Fatigue Questionnaire will be used to report fatigue.Scoring using a bimodal response system or a Likert score with weights assigned to each response choice. Likert or bimodal rating scales with 4 response options. For the Likert Scale: better than usual = 0, no more than usual = 1, worse than usual = 2, much worse than usual = 3. For the bimodal scale: better than usual = 0, no more than usual = 0, worse than usual = 1, much worse than usual = 1. Sum all items for a total score.

    27 february 2020

  • IS DEPRESSION DETERMINING THE QUALITY OF LIFE

    to report depression levels Beck Depression Inventory (BDI) will be used.Each of the four multiple choice answers is assigned a point value from 0 to 3. At the end of the assessment, you add up the total points from the answers throughout the 21 questions. Hıgh scores ındıcate worse depressıon levels

    27 february 2020

  • IS Anxıety DETERMINING THE QUALITY OF LIFE

    te report the effect of anxıety State-Trait Anxiety Inventory (STAI) will be used.The higher the score, the higher the level of anxiety.

    27 february 2020

  • Is pain disability DETERMINING THE QUALITY OF LIFE

    to report disability levels we will be used The Pain Disability Index.High score indicates high disability

    27 february 2020

Study Arms (2)

neck pain patients

servical disk hernisi servical spondilosis servical problems

Other: quality of life assesment

control

healthy people

Other: quality of life assesment

Interventions

The sociodemographic and clinical characteristics of the individuals who meet the study criteria will be recorded. Evaluations of the participants will be done only once

controlneck pain patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

people with a diagnosis of neck disease living in Ankara and who can answer the study questions

You may qualify if:

  • \) People 18 years and older

You may not qualify if:

  • Hospitalized people
  • Newly Operated People
  • People with psychological diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayça Aytar

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Organizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical therapist Phd

Study Record Dates

First Submitted

November 28, 2019

First Posted

December 17, 2019

Study Start

September 30, 2019

Primary Completion

March 25, 2020

Study Completion

April 25, 2020

Last Updated

April 30, 2020

Record last verified: 2019-01

Locations