OsteoarthritisNCT06825650
Investigation of the Cultural Adaptation, Validity, and Reliability of the Turkish Version of the CAP Questionnaire
An observational study of Osteoarthritis and Back Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The "CAP questionnaire," developed by modifying the CAP-Knee questionnaire to assess potential nociplastic pain features in painful musculoskeletal disorders, has been described. The "CAP questionnaire" is used in people with musculoskeletal pain and diagnostic subgroups of osteoarthritis, back pain, and fibromyalgia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Back Pain, Fibromyalgia
- What is being tested?
- Questionnaire study
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Nov 2024to 28 Nov 2027
- How long will I take part?
- 3 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of individuals who come to the university hospital for routine controls.
Who may be able to join
- People with musculoskeletal pain and in diagnoses with OA, back pain, or FM
- Above 18 years of age
- Informed consent of the participant
Who cannot join
- Diagnosis of uncontrolled/other clinically significant diseases (chronic obstructive pulmonary disease, congestive heart failure, endocrine system diseases, neurological, psychological diseases, etc.)
- Pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Ankara, Altındağ, 06100
Orkun Tüfekçi, PT, PhD(c), +90 312 305 25 25, orkuntf@gmail.com
About this study
Official title: Investigation of the Cultural Adaptation, Validity, and Reliability of the Turkish Version of the Central Aspects of Pain (CAP) Questionnaire
The "CAP questionnaire," developed by modifying the CAP-Knee questionnaire to assess potential nociplastic pain features in painful musculoskeletal disorders, has been described. The "CAP questionnaire" is used in people with musculoskeletal pain and diagnostic subgroups of osteoarthritis, back pain, and fibromyalgia. There is no Turkish version of the CAP questionnaire. This study aims to investigate the cultural adaptation, validity, and reliability of the Turkish version of the "CAP questionnaire."
Read the detailed description
Chronic pain is a symptom shared by many musculoskeletal conditions, even when disease management is optimized. Musculoskeletal pathologies are reported to be an essential therapeutic target in pain management. However, these pathologies often do not adequately explain the pain or the reason for its persistence.
Central sensitization is the increased sensitivity of Central Nervous System (CNS) neurons to a standard nociceptive input. Pain that increases in intensity and distribution beyond that explained by musculoskeletal pathology has been termed "nociplastic pain." Measuring these CNS aspects of pain is a prerequisite for understanding their mechanistic basis and predicting future pain and responses to treatment. Chronic pain is associated with CNS dysfunction in several areas, including depression, anxiety, pain catastrophizing, cognitive dysfunction, sleep disturbance, and fatigue. Considering the increasing importance of assessing mood-related pain (nociplastic pain) The "CAP questionnaire," developed by modifying the CAP-Knee questionnaire to assess potential nociplastic pain features in painful musculoskeletal disorders, has been described.
- Conditions
- Osteoarthritis, Back Pain, Fibromyalgia
- Being tested
- Questionnaire study
- Keywords
- nociplastic pain, central sensitization, back pain, osteoarthritis, fibromyalgia, pain
- Medical subject headings
- Osteoarthritis, Back Pain, Fibromyalgia, Nociplastic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire studyOther
Also called CAP questionnaire
Questionnaire application
| Study group | Role | What they receive |
|---|---|---|
| Individuals with osteoarthritis | Not described Receives: Other: Questionnaire study | |
| Individuals with back pain | Not described Receives: Other: Questionnaire study | |
| Individuals with fibromyalgia | Not described Receives: Other: Questionnaire study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Aspects of Pain Questionnaire (CAP)
The CAP questionnaire consists of eight items assessing each of the eight characteristics linked to the central mechanisms of knee pain over the past week. These items assess neuropathic-like pain, fatigue, cognition, catastrophizing, anxiety, depression, sleep, and widespread pain.
Measured: Three months
Secondary outcomes (6)
BETY-Biopsychosocial Questionnaire
Measured: Three months
Hospital Anxiety Depression Scale (HADS)
Measured: Three months
Health Assessment Questionnaire (HAQ)
Measured: Three months
Pain Catastrophizing Scale (PCS)
Measured: Three months
Central Sensitisation Inventory (CSI)
Measured: Three months
Short-Form of McGill's Pain Questionnaire
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start28 Nov 2024
- Primary completion28 Nov 2027 (estimated)
- Study completion28 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orkun Tüfekçi, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825650
- Sponsor's protocol ID
- SBA 24/997
- Status last verified
- Nov 2024
- First submitted
- 9 Feb 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will not be shared to protect the data of individuals
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Cultural Adaptation, Validity, and Reliability of the Turkish Version of the Central Aspects of Pain (CAP) Questionnaire
- ClinicalTrials.gov ID
- NCT06825650
- Acronym / sponsor ID
- SBA 24/997
- Conditions
- Osteoarthritis, Back Pain, Fibromyalgia
- Keywords
- nociplastic pain, central sensitization, back pain, osteoarthritis, fibromyalgia, pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 28 Nov 2024 (actual)
- Primary completion
- 28 Nov 2027 (estimated)
- Study completion
- 28 Nov 2027 (estimated)
- First posted
- 13 Feb 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.
The "CAP questionnaire," developed by modifying the CAP-Knee questionnaire to assess potential nociplastic pain features in painful musculoskeletal disorders, has been described. The "CAP questionnaire" is used in people with musculoskeletal pain and diagnostic subgroups of osteoarthritis, back pain, and fibromyalgia. There is no Turkish version of the CAP questionnaire. This study aims to investigate the cultural adaptation, validity, and reliability of the Turkish version of the "CAP questionnaire."
Detailed description
Chronic pain is a symptom shared by many musculoskeletal conditions, even when disease management is optimized. Musculoskeletal pathologies are reported to be an essential therapeutic target in pain management. However, these pathologies often do not adequately explain the pain or the reason for its persistence.
Central sensitization is the increased sensitivity of Central Nervous System (CNS) neurons to a standard nociceptive input. Pain that increases in intensity and distribution beyond that explained by musculoskeletal pathology has been termed "nociplastic pain." Measuring these CNS aspects of pain is a prerequisite for understanding their mechanistic basis and predicting future pain and responses to treatment. Chronic pain is associated with CNS dysfunction in several areas, including depression, anxiety, pain catastrophizing, cognitive dysfunction, sleep disturbance, and fatigue. Considering the increasing importance of assessing mood-related pain (nociplastic pain) The "CAP questionnaire," developed by modifying the CAP-Knee questionnaire to assess potential nociplastic pain features in painful musculoskeletal disorders, has been described.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individuals with osteoarthritis | – | Other: Questionnaire study |
| Individuals with back pain | – | Other: Questionnaire study |
| Individuals with fibromyalgia | – | Other: Questionnaire study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of individuals who come to the university hospital for routine controls.
Key inclusion criteria (3 listed)
- People with musculoskeletal pain and in diagnoses with OA, back pain, or FM
- Above 18 years of age
- Informed consent of the participant
Key exclusion criteria (2 listed)
- Diagnosis of uncontrolled/other clinically significant diseases (chronic obstructive pulmonary disease, congestive heart failure, endocrine system diseases, neurological, psychological diseases, etc.)
- Pregnant women
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 |
|---|---|---|
| Questionnaire studyAlso: CAP questionnaireQuestionnaire application | Other | Individuals with back pain, Individuals with fibromyalgia, Individuals with osteoarthritis |
Primary outcome
Central Aspects of Pain Questionnaire (CAP)
Time frame: Three months
The CAP questionnaire consists of eight items assessing each of the eight characteristics linked to the central mechanisms of knee pain over the past week. These items assess neuropathic-like pain, fatigue, cognition, catastrophizing, anxiety, depression, sleep, and widespread pain.
6 secondary outcomes
BETY-Biopsychosocial Questionnaire
Time frame: Three months
Hospital Anxiety Depression Scale (HADS)
Time frame: Three months
Health Assessment Questionnaire (HAQ)
Time frame: Three months
Pain Catastrophizing Scale (PCS)
Time frame: Three months
Central Sensitisation Inventory (CSI)
Time frame: Three months
Short-Form of McGill's Pain Questionnaire
Time frame: Three months
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 13 Feb 2025.
- Individual participant dataSharing planned: No. Will not be shared to protect the data of individuals
Related trials for Osteoarthritis
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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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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.
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 Osteoarthritis and Back 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 13 Feb 2025. 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?
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 Orkun Tüfekçi, PT, PhD (c) (5319502648, orkuntf@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Aspects of Pain Questionnaire (CAP) (time frame: Three months). 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 13 Feb 2025.