- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06825650
Investigation of the Cultural Adaptation, Validity, and Reliability of the Turkish Version of the CAP Questionnaire
Investigation of the Cultural Adaptation, Validity, and Reliability of the Turkish Version of the Central Aspects of Pain (CAP) Questionnaire
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Orkun Tüfekçi, PT, PhD (c)
- Phone Number: 5319502648
- Email: orkuntf@gmail.com
Study Locations
-
-
Altındağ
-
Ankara, Altındağ, Turkey, 06100
- Recruiting
- Hacettepe University
-
Contact:
- Orkun Tüfekçi, PT, PhD(c)
- Phone Number: +90 312 305 25 25
- Email: orkuntf@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- People with musculoskeletal pain and in diagnoses with OA, back pain, or FM
- Above 18 years of age
- Informed consent of the participant
Exclusion Criteria:
- Diagnosis of uncontrolled/other clinically significant diseases (chronic obstructive pulmonary disease, congestive heart failure, endocrine system diseases, neurological, psychological diseases, etc.)
- Pregnant women
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Individuals with osteoarthritis
|
Questionnaire application
Other Names:
|
|
Individuals with back pain
|
Questionnaire application
Other Names:
|
|
Individuals with fibromyalgia
|
Questionnaire application
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Three months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
BETY-Biopsychosocial Questionnaire
Time Frame: Three months
|
Three months
|
|
Hospital Anxiety Depression Scale (HADS)
Time Frame: Three months
|
Three months
|
|
Health Assessment Questionnaire (HAQ)
Time Frame: Three months
|
Three months
|
|
Pain Catastrophizing Scale (PCS)
Time Frame: Three months
|
Three months
|
|
Central Sensitisation Inventory (CSI)
Time Frame: Three months
|
Three months
|
|
Short-Form of McGill's Pain Questionnaire
Time Frame: Three months
|
Three months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBA 24/997
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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