Chronic Neck PainNCT04201379
Determines of Quality of Life in Patients
An observational study of Chronic Neck Pain, run by Baskent University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- quality of life assesment
- How many people
- 93 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2019to 25 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: people with a diagnosis of neck disease living in Ankara and who can answer the study questions
Who may be able to join
- 1) People 18 years and older
Who cannot join
- Hospitalized people
- Newly Operated People
- People with psychological diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nonspecific Neck Patients's Quality of Life and Their Predictors
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.
Read the detailed description
The study will include 93 people with a diagnosis neck disease who apply to the physical therapy outpatient clinic. After recorded sociodemographic and clinical characteristics of the individuals, some evaluations will be done only once. The evaluations to be used in the study are as follows: Pain Assesment will be evaluated with McGill Pain Questionnaire, Sleep disorders will be evaluated with Pitsburgh Sleep Quality Index (PSQI), Fatigue level will be assessed by the Fatigue Questionnaire, Beck Depression Inventory (BDI) will be used to determine depression levels. The quality of life of the subjects wiil be evaluate by using the Short Form-36 questionnaire.
- Conditions
- Chronic Neck Pain
- Being tested
- quality of life assesment
- Keywords
- chronic, neckpain
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality of life assesmentOther
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
| Study group | Role | What they receive |
|---|---|---|
| neck pain patients | servical disk hernisi servical spondilosis servical problems Receives: Other: quality of life assesment | |
| control | healthy people Receives: Other: quality of life assesment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 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.
Measured: 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])
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 27 february 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start30 Sep 2019
- Primary completion25 Mar 2020
- Study completion25 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayça Aytar TIĞLI, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201379
- Sponsor's protocol ID
- KA19/406
- Status last verified
- Jan 2019
- First submitted
- 28 Nov 2019
- Last updated
- 30 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonspecific Neck Patients's Quality of Life and Their Predictors
- ClinicalTrials.gov ID
- NCT04201379
- Acronym / sponsor ID
- KA19/406
- Conditions
- Chronic Neck Pain
- Keywords
- chronic, neckpain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 25 Mar 2020 (actual)
- Study completion
- 25 Apr 2020 (actual)
- First posted
- 17 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will include 93 people with a diagnosis neck disease who apply to the physical therapy outpatient clinic. After recorded sociodemographic and clinical characteristics of the individuals, some evaluations will be done only once. The evaluations to be used in the study are as follows: Pain Assesment will be evaluated with McGill Pain Questionnaire, Sleep disorders will be evaluated with Pitsburgh Sleep Quality Index (PSQI), Fatigue level will be assessed by the Fatigue Questionnaire, Beck Depression Inventory (BDI) will be used to determine depression levels. The quality of life of the subjects wiil be evaluate by using the Short Form-36 questionnaire.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neck pain patients | – | Other: quality of life assesmentservical disk hernisi servical spondilosis servical problems |
| control | – | Other: quality of life assesmenthealthy people |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- people with a diagnosis of neck disease living in Ankara and who can answer the study questions
Key inclusion criteria (1 listed)
- 1) People 18 years and older
Key exclusion criteria (3 listed)
- Hospitalized people
- Newly Operated People
- People with psychological diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quality of life assesmentThe sociodemographic and clinical characteristics of the individuals who meet the study criteria will be recorded. Evaluations of the participants will be done only once | Other | control, neck pain patients |
Primary outcome
DETERMINING FACTORS AFFECTING THE QUALITY OF LIFE
Time frame: 27 february 2020
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.)
IS PAIN DETERMINING THE QUALITY OF LIFE
Time frame: 27 february 2020
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.
IS PAIN INTENSITY DETERMINING THE QUALITY OF LIFE
Time frame: 27 february 2020
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])
IS SLEEP QUALİTY DETERMINING THE QUALITY OF LIFE
Time frame: 27 february 2020
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
IS FATIGUE DETERMINING THE QUALITY OF LIFE
Time frame: 27 february 2020
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.
IS DEPRESSION DETERMINING THE QUALITY OF LIFE
Time frame: 27 february 2020
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
IS Anxıety DETERMINING THE QUALITY OF LIFE
Time frame: 27 february 2020
te report the effect of anxıety State-Trait Anxiety Inventory (STAI) will be used.The higher the score, the higher the level of anxiety.
Is pain disability DETERMINING THE QUALITY OF LIFE
Time frame: 27 february 2020
to report disability levels we will be used The Pain Disability Index.High score indicates high disability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Neck Pain, run by Baskent University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DETERMINING FACTORS AFFECTING THE QUALITY OF LIFE (time frame: 27 february 2020). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2020.