Chronic Low-back PainNCT04099160
Turkish Version of Revised Neurophysiology of Pain Questionnaire
An observational study of Chronic Low-back Pain and Neck Pain, run by Akdeniz University at 2 sites in Turkey (Türkiye).
Trial summary
The Neurophysiology of Pain Questionnaire was first developed in English to test whether healthcare staff and patients could exactly understand pain neurophysiology. This questionnaire which contains 19 items was developed from the exam questions of students interested in post-graduate pain medicine. Catley et al. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low-back Pain, Neck Pain
- What is being tested?
- Evaluation
- How many people
- 182 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 20 Nov 2019to 20 Jan 2021
- How long will I take part?
- 7 Days
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic spinal pain
Who may be able to join
- Patients with spinal pain lasting more than three months
- Patients who older than 18 years of age
- Patients who can understand and read Turkish.
Who cannot join
- Patients with specific spinal pain such as trauma, fracture, infection, inflammatory disease and tumor
- Patients who have undergone spinal surgery in the last 3 months
- Patients who have received pain neurophysiology education in the last year.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Akdeniz University Department of phyiotherapy
Antalya
Akdeniz University Medical Ethics Committe
Antalya
About this study
Official title: Cross-cultural Adaptation of Revised Neurophysiology of Pain Questionnaire Into Turkish Language
The Neurophysiology of Pain Questionnaire was first developed in English to test whether healthcare staff and patients could exactly understand pain neurophysiology. This questionnaire which contains 19 items was developed from the exam questions of students interested in post-graduate pain medicine. Catley et al. (2013) investigated the psychometric properties of the modified Neurophysiology of Pain Questionnaire with a few word differences from the original version by conducting a rash analysis on 300 patients with chronic spinal pain. Acceptable internal consistency and test-retest reliability of the questionnaire were recorded. However, it was stated that 7 items negatively affect psychometric properties of the questionnaire. As a result, the author concluded that the questionnaire had sufficient psychometric properties for use in chronic spinal pain subjects, but further studies were needed. The Neurophysiology of Pain Questionnaire was used to measure a knowledge about pain in different studies. The validity and reliability studies of the Dutch, French and Brazlian Portuguese versions of the Neurophysiology of Pain Questionnaire were conducted in the literature. The aim of our study was to translate the Revised Neurophysiology of Pain Questionnaire into Turkish language and to investigate its psychometric properties.
- Conditions
- Chronic Low-back Pain, Neck Pain
- Being tested
- Evaluation
- Keywords
- neurophysiology pain questionnaire, reliability, validity, pain, low back pain
- Medical subject headings
- Neck Pain, Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvaluationOther
The Turkish version of the Revised Neurophysiology of Pain Questionnaire will be applied to patients with chronic spinal pain at the beginning of the study and a week later. The Visual Analogue Scale and the Short Form-36 (SF-36) questionnaire will be applied to patients only at the beginning of the stuy.
What is being measured
The primary outcome is the main question the study is designed to answer.
The Revised Neurophysiology of Pain Questionnaire
The Revised Neurophysiology of Pain Questionnaire consists of 12 items and measuring the level of knowledge about pain neurophysiology. High score indicates a high level of knowledge about pain neurophysiology.
Measured: Two minute
Secondary outcomes (2)
Visual Analogue Scale
Visual Analogue Scale assessed pain severity. Visual Analog Scale is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of pain. hence the left end is usually labeled 'no pain', and the right end usually labeled 'extreme pain'. The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark by using a ruler. The scale is provided a range of scores from 0-100. High score indicates a high level of pain..
Measured: 1 minute
Short Form-36
Short Form-36 (SF-36) questionnaire has 8 subscales such as physical function, role limitations due to physical problems, pain, general perception of health, energy, social function, role limitations due to emotional problems, mental health. This questioonaire evaluate quality of life. Scales have a fairly small range of response options, and scores are multiplied up to 0-100.
Measured: Ten minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start20 Nov 2019
- Primary completion20 Oct 2020
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by Akdeniz 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
- Other
- Time perspective
- Prospective
- Enrolment
- 182 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Gül, Akdeniz University
- Investigators
- Hatice Gül, Ph.D, Principal investigator, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099160
- Sponsor's protocol ID
- 34878437-199-E.115170
- Status last verified
- Jan 2024
- First submitted
- 19 Sep 2019
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data obtained from patients at the beginning and a week later will be analyzed with SPSS program.
Publications
Catley MJ, O'Connell NE, Moseley GL. How good is the neurophysiology of pain questionnaire? A Rasch analysis of psychometric properties. J Pain. 2013 Aug;14(8):818-27. doi: 10.1016/j.jpain.2013.02.008. Epub 2013 May 4.
PubMed 23651882
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-cultural Adaptation of Revised Neurophysiology of Pain Questionnaire Into Turkish Language
- ClinicalTrials.gov ID
- NCT04099160
- Acronym / sponsor ID
- 34878437-199-E.115170
- Conditions
- Chronic Low-back Pain, Neck Pain
- Keywords
- neurophysiology pain questionnaire, reliability, validity, pain, low back pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 23 Sep 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.
The Neurophysiology of Pain Questionnaire was first developed in English to test whether healthcare staff and patients could exactly understand pain neurophysiology. This questionnaire which contains 19 items was developed from the exam questions of students interested in post-graduate pain medicine. Catley et al. (2013) investigated the psychometric properties of the modified Neurophysiology of Pain Questionnaire with a few word differences from the original version by conducting a rash analysis on 300 patients with chronic spinal pain. Acceptable internal consistency and test-retest reliability of the questionnaire were recorded. However, it was stated that 7 items negatively affect psychometric properties of the questionnaire. As a result, the author concluded that the questionnaire had sufficient psychometric properties for use in chronic spinal pain subjects, but further studies were needed. The Neurophysiology of Pain Questionnaire was used to measure a knowledge about pain in different studies. The validity and reliability studies of the Dutch, French and Brazlian Portuguese versions of the Neurophysiology of Pain Questionnaire were conducted in the literature. The aim of our study was to translate the Revised Neurophysiology of Pain Questionnaire into Turkish language and to investigate its psychometric properties.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic spinal pain
Key inclusion criteria (3 listed)
- Patients with spinal pain lasting more than three months
- Patients who older than 18 years of age
- Patients who can understand and read Turkish.
Key exclusion criteria (3 listed)
- Patients with specific spinal pain such as trauma, fracture, infection, inflammatory disease and tumor
- Patients who have undergone spinal surgery in the last 3 months
- Patients who have received pain neurophysiology education in the last year.
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 |
|---|---|---|
| EvaluationThe Turkish version of the Revised Neurophysiology of Pain Questionnaire will be applied to patients with chronic spinal pain at the beginning of the study and a week later. The Visual Analogue Scale and the Short Form-36 (SF-36) questionnaire will be applied to patients only at the beginning of the stuy. | Other | – |
Primary outcome
The Revised Neurophysiology of Pain Questionnaire
Time frame: Two minute
The Revised Neurophysiology of Pain Questionnaire consists of 12 items and measuring the level of knowledge about pain neurophysiology. High score indicates a high level of knowledge about pain neurophysiology.
2 secondary outcomes
Visual Analogue Scale
Time frame: 1 minute
Short Form-36
Time frame: Ten minute
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 19 Jan 2024.
- Background: PubMed 23651882Catley MJ, O'Connell NE, Moseley GL. How good is the neurophysiology of pain questionnaire? A Rasch analysis of psychometric properties. J Pain. 2013 Aug;14(8):818-27. doi: 10.1016/j.jpain.2013.02.008. Epub 2013 May 4.
- Individual participant dataSharing planned: No. The data obtained from patients at the beginning and a week later will be analyzed with SPSS program.
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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.
Hatice Gül, Ph.D principal investigator
Akdeniz University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low-back Pain and Neck Pain, run by Akdeniz University at 2 sites 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 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 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The Revised Neurophysiology of Pain Questionnaire (time frame: Two minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04099160, which also lists 1 linked publication.
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 19 Jan 2024.