Minimal Clinical Important Change of the Turkish Versions of the FABQ TKS, and PCS in Patients With Chronic Neck Pain

Neck Pain Clinical Trial

Official title:

Evaluation of the Responsibility and Minimal Clinical Important Change of the Turkish Versions of the Fear-Avoidance Beliefs Questionnaire, Tampa Kinesiophobia Scale,and Pain Catastrophizing Scale in Patients With Chronic Neck Pain.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06194812
• Other study ID #: 2023-19/651
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: Acibadem University
• Contact: irmak çavusoglu, PhD
• Phone: 05346028050
• Email: irmak.cavusoglu[@]acibadem.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:A definitive diagnosis of chronic nonspecific neck pain (documented history of neck pain lasting more than twelve weeks without a recognizable, specific pathoanatomical cause of the pain)

• 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

Exclusion Criteria:

• 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 (

Related Conditions & MeSH terms

• Fear of Movement
• Kinesiophobia
• Neck Pain

Intervention

Other:
• Pain Catastrophizing scale
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.

Locations

Country	Name	City	State
Turkey	Avicenna Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Kinesiophobia	It is aimed to evaluate the responsibility and minimal clinical significance of the Turkish versions of the Tampa Kinesiophobia scale in patients with non-specific chronic neck pain.	baseline and after 8 weeks
Secondary	Pain Catastrophizing	It is aimed to evaluate the responsibility and minimal clinical significance of the Turkish versions of the Pain Catastrophizing scale in patients with non-specific chronic neck pain.	baseline and after 8 weeks