Neck PainNCT05233969
Pain-Related Self-Efficacy in Individuals With Chronic Neck Pain
An observational study of Neck Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The factors affecting pain-related self-efficacy in individuals with chronic neck pain were investigated. A total of 69 subjects participated in the study. After the demographic data of the subjects were taken, pain-self-efficacy questionnaire, Timed Up and Go Test, Berg Balance Scale and International Physical… Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Neck Pain
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 30 Jun 2022
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with chronic neck pain
Who may be able to join
- Adults aged 30 to 65 years,
- Adults with neck pain for at least 3 months,
- Having a score of 3 or more on the visual analog scale for pain ,
- To be willing to participate in the study.
Who cannot join
- Diagnosed with neurological, vestibular, rheumatic, or endocrine disorders,
- Had previous spinal surgery, neck trauma associated with post-traumatic amnesia or concurrent head injury, or cervical fracture or dislocation,
- currently receiving treatment for neck pathology.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Merve Karapinar
Isparta
MERVE KARAPINAR, +905079089066, mervekarapinar1306@gmail.com
About this study
Official title: An Investigation of Factors Affecting Pain-Related Self-Efficacy in Individuals With Chronic Neck Pain
The factors affecting pain-related self-efficacy in individuals with chronic neck pain were investigated. A total of 69 subjects participated in the study. After the demographic data of the subjects were taken, pain-self-efficacy questionnaire, Timed Up and Go Test, Berg Balance Scale and International Physical Activity Questionnaire were administered, respectively.
- Conditions
- Neck Pain
- Keywords
- Neck Pain, Self Efficacy, Physical Activity
- Medical subject headings
- Neck Pain, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain-Self-Efficacy Questionnaire(PSEQ)
The Pain Self-Efficacy Questionnaire is composed of 10 items assessing the patient's self-efficacy beliefs on performing a range of life activities taking pain into consideration. Each item is rated on a 7-point Likert scale ranging from 0 = not at all confident to 6 = completely confident. The maximum possible score is 60. A high Pain Self-Efficacy Questionnaire score indicates a high level of belief in one's self-efficacy in performing life activities despite experiencing pain.
Measured: five minutes
Secondary outcomes (3)
Time Up and Go(TUG)
Patients were required to stand up from a chair with armrests, walk 3 meters, turn around, return to the chair and sit down as fast as possible. The time taken to complete this task was recorded in seconds with a stopwatch. Three trials were recorded per patient and the mean time to perform the task was calculated for each patient. The mean time interval between each trial was 1 minute.
Measured: five minutes
Berg Balance Scale(BBS)
The BBS26 is a functional balance measurement and consists of 14 items. Each item is a 5-point ordinal scale ranging from 0 to 4, with 0 indicating an inability to complete the task entirely and 4 indicating an ability to complete the task criterion. Scores can range from 0 to 56. The higher the score, the better the balance.
Measured: ten minutes
International Physical Activity Questionnaire(IPAQ)
The IPAQ is used to assess habitual physical activitiy during the past 7 days. The IPAQ used in the present study is the long version which covers four domains of physical activity: occupational (7 items), transportation (6 items), household/gardening (6 items) and leisure-time activities (6 items). The questionnaire also includes two questions about the time spent on sitting as an indicator of sedentary behavior. The number of days per week and the time spent on walking per day as well as moderate and vigorous activities from all four domains are recorded. The IPAQ data were converted to metabolic equivalent scores (MET-min-week-1) for each type of activity, by multiplying the number of minutes dedicated to each activity class by the specific MET score for that activity. Physical activity levels were also classified into three categories: inactive, minimally active and health-enhancing physically active, according to the scoring system provided by the IPAQ.
Measured: ten minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start1 Feb 2022
- Primary completion20 Mar 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MERVE KARAPINAR, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233969
- Sponsor's protocol ID
- 326
- Status last verified
- Feb 2022
- First submitted
- 1 Feb 2022
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Factors Affecting Pain-Related Self-Efficacy in Individuals With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT05233969
- Acronym / sponsor ID
- 326
- Conditions
- Neck Pain
- Keywords
- Neck Pain, Self Efficacy, Physical Activity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 20 Mar 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 10 Feb 2022 (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.
The factors affecting pain-related self-efficacy in individuals with chronic neck pain were investigated. A total of 69 subjects participated in the study. After the demographic data of the subjects were taken, pain-self-efficacy questionnaire, Timed Up and Go Test, Berg Balance Scale and International Physical Activity Questionnaire were administered, respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with chronic neck pain
Key inclusion criteria (4 listed)
- Adults aged 30 to 65 years,
- Adults with neck pain for at least 3 months,
- Having a score of 3 or more on the visual analog scale for pain ,
- To be willing to participate in the study.
Key exclusion criteria (3 listed)
- Diagnosed with neurological, vestibular, rheumatic, or endocrine disorders,
- Had previous spinal surgery, neck trauma associated with post-traumatic amnesia or concurrent head injury, or cervical fracture or dislocation,
- currently receiving treatment for neck pathology.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain-Self-Efficacy Questionnaire(PSEQ)
Time frame: five minutes
The Pain Self-Efficacy Questionnaire is composed of 10 items assessing the patient's self-efficacy beliefs on performing a range of life activities taking pain into consideration. Each item is rated on a 7-point Likert scale ranging from 0 = not at all confident to 6 = completely confident. The maximum possible score is 60. A high Pain Self-Efficacy Questionnaire score indicates a high level of belief in one's self-efficacy in performing life activities despite experiencing pain.
3 secondary outcomes
Time Up and Go(TUG)
Time frame: five minutes
Berg Balance Scale(BBS)
Time frame: ten minutes
International Physical Activity Questionnaire(IPAQ)
Time frame: ten minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: No
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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.
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 Neck Pain, run by Hacettepe 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 4 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: status not confirmed, as of the sponsor's last update on 2 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MERVE KARAPINAR (+905079089066, mervekarapinar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain-Self-Efficacy Questionnaire(PSEQ) (time frame: five minutes). 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 2 Mar 2022.