Neck PainNCT05606666
Reliability of the Neurophysiology of Pain Questionnaire in the Neck Pain the Cross-validation Study
An observational study of Neck Pain and Pain Knowledge, run by Istanbul Arel University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to study the validity and reliability of the Modified Pain Neurophysiology Questionnaire in patients with neck pain. After the ethics committee approval, women and men in Turkey will be invited to the research via online advertisements (researchers' facebook, instagram, twitter accounts). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain, Pain Knowledge
- What is being tested?
- reliability of the NPQ
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 1 May 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Persons who meet the inclusion criteria and who volunteered to participate in the study
Who may be able to join
- be between the ages of 18-65
- Having neck pain complaints for the last 3 months
- Adult individuals who agreed to participate in the study. Their mother tongue is Turkish.
Who cannot join
- Not answering all the questions
Trial locations and contacts
1 site in 1 country.
Özden YAŞARER contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İstanbul
Istanbul
Özden YAŞARER, 5343845684, ozdenyasarer@gmail.com
Özden YAŞARER
About this study
The aim of this study is to study the validity and reliability of the Modified Pain Neurophysiology Questionnaire in patients with neck pain. After the ethics committee approval, women and men in Turkey will be invited to the research via online advertisements (researchers' facebook, instagram, twitter accounts). The scale will be translated from English to Turkish by two people who are fluent in Turkish and English. A single Turkish translation will be obtained with a common opinion from these two Turkish translations. In ten trial phases, a preliminary assessment will be conducted with 15 participants to test the intelligibility of the scale. If there are participants who think that there is a problem with the intelligibility of the scale, they will be asked to explain which items they have problems understanding and why. After individuals are informed with the online voluntary consent form, participants will be asked to complete the Modified Pain Neurophysiology questionnaire. Modified Pain Neurophysiology scale questions and questions in the data collection form will be prepared through the google surveys application and will be sent to the participants via Whatsapp, Facebook, Instagram and e-mail. Participants will fill out the survey forms online. In order to evaluate the validity of the Modified Pain Neurophysiology questionnaire, the pain subscale of the SF-36 scale, which has been validated in Turkish, will be used (McHorney, Ware, Lu, and Sherbourne, 1994), (Kocyigit et al., 1999). Scales after 15 days to assess test-retest reliability will be repeated.
- Conditions
- Neck Pain, Pain Knowledge
- Being tested
- reliability of the NPQ
- Keywords
- neck pain, neurophysiology of pain, pain knowledge, pain education
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reliability of the NPQOther
The aim of this study is to study the validity and reliability of the Modified Pain Neurophysiology Questionnaire in patients with neck pain.
What is being measured
The primary outcome is the main question the study is designed to answer.
pain subscale of the SF-36 questionnaire
We will use only the pain subscale of the validated Turkish version of the SF-36 questionnaire
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start1 Oct 2022
- Primary completion30 Oct 2022
- Study completion1 May 2023 (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.
- 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
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Arel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özden Laçin, Istanbul Arel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606666
- Sponsor's protocol ID
- NPQ Cross-validation
- Status last verified
- Oct 2022
- First submitted
- 31 Oct 2022
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of the Neurophysiology of Pain Questionnaire in the Neck Pain the Cross-validation Study
- ClinicalTrials.gov ID
- NCT05606666
- Acronym / sponsor ID
- NPQ Cross-validation
- Conditions
- Neck Pain, Pain Knowledge
- Keywords
- neck pain, neurophysiology of pain, pain knowledge, pain education
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Istanbul Arel UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 7 Nov 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 aim of this study is to study the validity and reliability of the Modified Pain Neurophysiology Questionnaire in patients with neck pain. After the ethics committee approval, women and men in Turkey will be invited to the research via online advertisements (researchers' facebook, instagram, twitter accounts). The scale will be translated from English to Turkish by two people who are fluent in Turkish and English. A single Turkish translation will be obtained with a common opinion from these two Turkish translations. In ten trial phases, a preliminary assessment will be conducted with 15 participants to test the intelligibility of the scale. If there are participants who think that there is a problem with the intelligibility of the scale, they will be asked to explain which items they have problems understanding and why. After individuals are informed with the online voluntary consent form, participants will be asked to complete the Modified Pain Neurophysiology questionnaire. Modified Pain Neurophysiology scale questions and questions in the data collection form will be prepared through the google surveys application and will be sent to the participants via Whatsapp, Facebook, Instagram and e-mail. Participants will fill out the survey forms online. In order to evaluate the validity of the Modified Pain Neurophysiology questionnaire, the pain subscale of the SF-36 scale, which has been validated in Turkish, will be used (McHorney, Ware, Lu, and Sherbourne, 1994), (Kocyigit et al., 1999). Scales after 15 days to assess test-retest reliability will be repeated.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Persons who meet the inclusion criteria and who volunteered to participate in the study
Key inclusion criteria (3 listed)
- be between the ages of 18-65
- Having neck pain complaints for the last 3 months
- Adult individuals who agreed to participate in the study. Their mother tongue is Turkish.
Key exclusion criteria (1 listed)
- Not answering all the questions
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 |
|---|---|---|
| reliability of the NPQThe aim of this study is to study the validity and reliability of the Modified Pain Neurophysiology Questionnaire in patients with neck pain. | Other | – |
Primary outcome
pain subscale of the SF-36 questionnaire
Time frame: baseline
We will use only the pain subscale of the validated Turkish version of the SF-36 questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
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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.
Özden YAŞARER contact
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 and Pain Knowledge, run by Istanbul Arel 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 3 inclusion and 1 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 7 Nov 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 Özden YAŞARER (05363845684, ozdenyasarer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain subscale of the SF-36 questionnaire (time frame: baseline). 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 7 Nov 2022.