NCT06825650

Brief 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. 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."

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Nov 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress48%
Nov 2024Nov 2027

Study Start

First participant enrolled

November 28, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2027

Last Updated

February 13, 2025

Status Verified

November 1, 2024

Enrollment Period

3 years

First QC Date

February 9, 2025

Last Update Submit

February 9, 2025

Conditions

Keywords

nociplastic paincentral sensitizationback painosteoarthritisfibromyalgiapain

Outcome Measures

Primary Outcomes (1)

  • 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.

    Three months

Secondary Outcomes (6)

  • BETY-Biopsychosocial Questionnaire

    Three months

  • Hospital Anxiety Depression Scale (HADS)

    Three months

  • Health Assessment Questionnaire (HAQ)

    Three months

  • Pain Catastrophizing Scale (PCS)

    Three months

  • Central Sensitisation Inventory (CSI)

    Three months

  • +1 more secondary outcomes

Study Arms (3)

Individuals with osteoarthritis

Other: Questionnaire study

Individuals with back pain

Other: Questionnaire study

Individuals with fibromyalgia

Other: Questionnaire study

Interventions

Questionnaire application

Also known as: CAP questionnaire
Individuals with back painIndividuals with fibromyalgiaIndividuals with osteoarthritis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population will consist of individuals who come to the university hospital for routine controls.

You may qualify if:

  • People with musculoskeletal pain and in diagnoses with OA, back pain, or FM
  • Above 18 years of age
  • Informed consent of the participant

You may not qualify if:

  • Diagnosis of uncontrolled/other clinically significant diseases (chronic obstructive pulmonary disease, congestive heart failure, endocrine system diseases, neurological, psychological diseases, etc.)
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Altındağ, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

OsteoarthritisBack PainFibromyalgiaNociplastic PainPain

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesNeuromuscular DiseasesNervous System Diseases

Central Study Contacts

Orkun Tüfekçi, PT, PhD (c)

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, PT, PhD(c)

Study Record Dates

First Submitted

February 9, 2025

First Posted

February 13, 2025

Study Start

November 28, 2024

Primary Completion (Estimated)

November 28, 2027

Study Completion (Estimated)

November 28, 2027

Last Updated

February 13, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Will not be shared to protect the data of individuals

Locations