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

December 22, 2023 updated by: Irmak ÇAVUŞOĞLU, Acibadem University

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Avicenna Hospital
        • Contact:
          • Asiye Koçak

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 (

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: İNTERVENTİON
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

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.

Other Names:
  • Fear-Avoidance Beliefs Questionnaire, and Pain Catastrophizing scale
  • Tampa Kinesiophobia scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fear-Avoidance
Time Frame: baseline and after 8 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kinesiophobia
Time Frame: baseline and after 8 weeks
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
Pain Catastrophizing
Time Frame: baseline and after 8 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem University

Investigators

  • Study Chair: Nuray Alaca, assoc.prof., Acibadem University
  • Study Chair: Elif Esma Safran, PhD, Acibadem University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 15, 2024

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 13, 2023

First Submitted That Met QC Criteria

December 22, 2023

First Posted (Estimated)

January 8, 2024

Study Record Updates

Last Update Posted (Estimated)

January 8, 2024

Last Update Submitted That Met QC Criteria

December 22, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-19/651

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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