Nonspecific Chronic Low Back PainNCT07033377
Psychometric Validation of Persian CBQ-NSCLBP
An observational study of Nonspecific Chronic Low Back Pain, run by Kourosh Najafi.
Trial summary
This study aims to translate, culturally adapt, and psychometrically validate the Persian version of the Cognitive Behavioral Questionnaire in Nonspecific Chronic Low Back Pain (CBQ-NSCLBP). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nonspecific Chronic Low Back Pain
- What is being tested?
- Self-administered paper-based questionnaires
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adults aged 18-65 years diagnosed with nonspecific chronic low back pain by a physician, who are fluent in Persian and able to complete questionnaires independently. Participants will be recruited from physiotherapy clinics and outpatient rehabilitation centers.
Who may be able to join
- Age between 18 - 65 years old.
- Experiencing nonspecific low back pain for at least 6 months.
- Have a physician-confirmed diagnosis.
- Be able to read and understand Persian.
- Be willing to participate and provide written informed consent.
Who cannot join
- Specific causes of low back pain (e.g., spinal infection, tumor, fracture, inflammatory disease, radiculopathy, or other neurological disorders).
- Severe psychiatric disorders or cognitive impairments interfering with questionnaire comprehension.
- History of surgery for low back pain.
- Abnormal bowel or bladder function.
- Pregnant at the time of participation.
- Not fluent in Persian.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Cross-Cultural Adaptation and Psychometric Validation of the Persian Version of the Cognitive Behavioral Questionnaire in Nonspecific Chronic Low Back Pain
This study aims to translate, culturally adapt, and psychometrically validate the Persian version of the Cognitive Behavioral Questionnaire in Nonspecific Chronic Low Back Pain (CBQ-NSCLBP). The process will follow standard cross-cultural adaptation guidelines, including forward-backward translation, expert review, and pilot testing. The psychometric properties, including internal consistency, test-retest reliability, and construct validity, will be evaluated in a sample of Persian-speaking adults with nonspecific chronic low back pain.
Read the detailed description
Chronic low back pain (CLBP) is a common and persistent musculoskeletal condition that affects a large portion of the population and can lead to long-term disability. It is typically defined as pain in the lower back that lasts for more than 12 weeks and often impacts daily function and quality of life.
In addition to physical symptoms, people with CLBP frequently experience cognitive and behavioral challenges, such as fear-avoidance beliefs, catastrophizing, and difficulty concentrating. These factors can contribute to ongoing disability and interfere with the rehabilitation process.
The Cognitive Behavioral Questionnaire for Nonspecific Chronic Low Back Pain (CBQ-NSCLBP) was developed to assess these cognitive-behavioral aspects in people with nonspecific CLBP. However, it has only been validated in one population and has not yet been adapted for Persian-speaking individuals.
This study aims to translate and culturally adapt the CBQ-NSCLBP into Persian and evaluate its psychometric properties in individuals with nonspecific chronic low back pain
- Conditions
- Nonspecific Chronic Low Back Pain
- Being tested
- Self-administered paper-based questionnaires
- Keywords
- chronic low back pain, CBQ-NSCLBP, Persian version, cross-cultural adaptation, psychometric validation, CLBP, cognitive behavioral questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-administered paper-based questionnairesOther
Participants will complete the Persian version of the CBQ-NSCLBP and other self-report measures as part of a psychometric validation study. No clinical or therapeutic intervention is involved.
What is being measured
The primary outcome is the main question the study is designed to answer.
CBQ-NSCLBP
Evaluation of the internal consistency, test-retest reliability, and construct validity of the Persian version of the Cognitive Behavioral Questionnaire in Nonspecific Chronic Low Back Pain (CBQ-NSCLBP).
Measured: Baseline and within 6 to 10 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study startJul 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonspecific Chronic Low Back 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kourosh Najafi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kourosh Najafi, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033377
- Sponsor's protocol ID
- MEDI-CBQNSCLBP-Pe
- Status last verified
- Jun 2025
- First submitted
- 13 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- 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 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Cultural Adaptation and Psychometric Validation of the Persian Version of the Cognitive Behavioral Questionnaire in Nonspecific Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT07033377
- Acronym / sponsor ID
- MEDI-CBQNSCLBP-Pe
- Conditions
- Nonspecific Chronic Low Back Pain
- Keywords
- chronic low back pain, CBQ-NSCLBP, Persian version, cross-cultural adaptation, psychometric validation, CLBP, cognitive behavioral questionnaire
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Kourosh NajafiUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 24 Jun 2025 (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.
This study aims to translate, culturally adapt, and psychometrically validate the Persian version of the Cognitive Behavioral Questionnaire in Nonspecific Chronic Low Back Pain (CBQ-NSCLBP). The process will follow standard cross-cultural adaptation guidelines, including forward-backward translation, expert review, and pilot testing. The psychometric properties, including internal consistency, test-retest reliability, and construct validity, will be evaluated in a sample of Persian-speaking adults with nonspecific chronic low back pain.
Detailed description
Chronic low back pain (CLBP) is a common and persistent musculoskeletal condition that affects a large portion of the population and can lead to long-term disability. It is typically defined as pain in the lower back that lasts for more than 12 weeks and often impacts daily function and quality of life.
In addition to physical symptoms, people with CLBP frequently experience cognitive and behavioral challenges, such as fear-avoidance beliefs, catastrophizing, and difficulty concentrating. These factors can contribute to ongoing disability and interfere with the rehabilitation process.
The Cognitive Behavioral Questionnaire for Nonspecific Chronic Low Back Pain (CBQ-NSCLBP) was developed to assess these cognitive-behavioral aspects in people with nonspecific CLBP. However, it has only been validated in one population and has not yet been adapted for Persian-speaking individuals.
This study aims to translate and culturally adapt the CBQ-NSCLBP into Persian and evaluate its psychometric properties in individuals with nonspecific chronic low back pain
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18-65 years diagnosed with nonspecific chronic low back pain by a physician, who are fluent in Persian and able to complete questionnaires independently. Participants will be recruited from physiotherapy clinics and outpatient rehabilitation centers.
Key inclusion criteria (5 listed)
- Age between 18 - 65 years old.
- Experiencing nonspecific low back pain for at least 6 months.
- Have a physician-confirmed diagnosis.
- Be able to read and understand Persian.
- Be willing to participate and provide written informed consent.
Key exclusion criteria (6 listed)
- Specific causes of low back pain (e.g., spinal infection, tumor, fracture, inflammatory disease, radiculopathy, or other neurological disorders).
- Severe psychiatric disorders or cognitive impairments interfering with questionnaire comprehension.
- History of surgery for low back pain.
- Abnormal bowel or bladder function.
- Pregnant at the time of participation.
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 |
|---|---|---|
| Self-administered paper-based questionnairesParticipants will complete the Persian version of the CBQ-NSCLBP and other self-report measures as part of a psychometric validation study. No clinical or therapeutic intervention is involved. | Other | – |
Primary outcome
CBQ-NSCLBP
Time frame: Baseline and within 6 to 10 days after enrollment
Evaluation of the internal consistency, test-retest reliability, and construct validity of the Persian version of the Cognitive Behavioral Questionnaire in Nonspecific Chronic Low Back Pain (CBQ-NSCLBP).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Nonspecific Chronic Low Back Pain, run by Kourosh Najafi.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kourosh Najafi (+905398709096, kourosh.najafi@std.medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CBQ-NSCLBP (time frame: Baseline and within 6 to 10 days after enrollment). 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 24 Jun 2025.