NCT06194812

Brief Summary

To investigate the reliability and sensitivity of the Fear-Avoidance Beliefs Questionnaire, Tampa Kinesiophobia Scale, and Pain Catastrophizing Scale in patients with chronic nonspecific neck pain undergoing multidisciplinary rehabilitation and to determine the most appropriate minimally clinically significant difference values in order to increase confidence in their use in clinical practice and research for this patient population. Therefore, the current study aims to evaluate the answerability and minimal clinical significance of the Turkish versions of the Fear-Avoidance Beliefs Questionnaire, Tampa Kinesiophobia scale, and Pain Catastrophizing scales in patients with non-specific chronic neck pain.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 8, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

January 15, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 8, 2024

Status Verified

December 1, 2023

Enrollment Period

12 months

First QC Date

December 13, 2023

Last Update Submit

December 22, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Fear-Avoidance

    It is aimed to evaluate the responsibility and minimal clinical significance of the Fear-Avoidance Beliefs Questionnaire in patients with non-specific chronic neck pain.

    baseline and after 8 weeks

Secondary Outcomes (2)

  • Kinesiophobia

    baseline and after 8 weeks

  • Pain Catastrophizing

    baseline and after 8 weeks

Study Arms (1)

İNTERVENTİON

OTHER

The surveys in the study will be applied to the patients in this group and initial and final measurements will be taken.

Other: Pain Catastrophizing scale

Interventions

Participants' fear and avoidance behaviors will be evaluated with the Fear Avoidance Beliefs Questionnaire (KKBS) (Appendix 2). Participants' fear of movement will be evaluated with the Tampa Kinesiophobia Scale (TKS) (Appendix 3). Pain Catastrophizing Scale (PAS) (Appendix 4) will be used to evaluate the participants' pain-related thoughts and feelings. The amount of improvement in symptoms perceived by the participants will be evaluated at the end of the treatment with the Global Perceived Impact Scale (GAES) (Appendix 5). Participants were asked "How would you describe your current situation compared to the beginning of treatment?" question will be asked.

Also known as: Fear-Avoidance Beliefs Questionnaire, and Pain Catastrophizing scale, Tampa Kinesiophobia scale
İNTERVENTİON

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Good Turkish communication skills
  • Both genders must be between the ages of 18 and 65,
  • Agreeing to participate in the research and signing the voluntary consent form

You may not qualify if:

  • Systemic disease, cognitive impairment (Mini Mental State Examination \<24),
  • Recent (\<12 weeks) myocardial infarction, cerebrovascular accident
  • Rheumatoid arthritis, neurological disorders, radiculopathy, infection, tumor, osteoporosis, vertebral fracture, trauma and surgery in the cervical region.
  • Having previously received any exercise therapy and/or pain neuroscience training.
  • Refusal of treatment or failure to comply with treatment (

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Avicenna Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck PainKinesiophobia

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPhobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Nuray Alaca, assoc.prof.

    Acibadem University

    STUDY CHAIR
  • Elif Esma Safran, PhD

    Acibadem University

    STUDY CHAIR

Central Study Contacts

ırmak çavuşoğlu, PhD

CONTACT

Irmak çavuşoğlu

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

December 13, 2023

First Posted

January 8, 2024

Study Start

January 15, 2024

Primary Completion

December 30, 2024

Study Completion

December 1, 2025

Last Updated

January 8, 2024

Record last verified: 2023-12

Locations