Answerability and Minimal Clinical Significance of the Pain Questionnaires

August 13, 2024 updated by: Acibadem University

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 Low Back Pain

To investigate the reliability and sensitivity of the Turkish versions of the Fear-Avoidance Beliefs Questionnaire, Tampa Scale for Kinesiophobia, and The Pain Catastrophizing Scale in patients with chronic non-specific low back pain undergoing multidisciplinary rehabilitation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Nonspecific chronic low back pain is a common condition that can have a significant impact on patient's daily lives and beliefs. Patients often believe that there is a strong relationship between structural changes in the lower back, pain, and activities of daily living. Patients with nonspecific low back pain may have lower expectations for recovery because they tend to believe that their condition is chronic and unlikely to improve significantly. Patients' beliefs and perceptions of their condition can influence the clinical management of low back pain. Tampa Scale for Kinesiophobia (TSK), Fear-Avoidance Beliefs Questionnaire (FABQ), and The Pain Catastrophizing Scale (PCS) are commonly used in patients with non-specific chronic low back pain. The common feature of these scales is that they evaluate issues such as pain perception, pain-related beliefs, and pain coping strategies. The use of these scales can provide important information to better respond to individuals' needs in pain management and rehabilitation processes. However, the minimal clinical relevance and answerability of the surveys were not explicitly discussed in the search results. Further research is needed to investigate the clinical consequences of fear-avoidance beliefs and their potential impact on treatment outcomes for patients with chronic low back pain.

Study Type

Observational

Enrollment (Estimated)

100

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
    • None Selected
      • Istanbul, None Selected, Turkey, 34752
        • Recruiting
        • Elif Esma Safran
        • Contact:
        • Principal Investigator:
          • Elif E Safran, asst. prof.
        • Contact:
        • Principal Investigator:
          • Irmak I Çavuşoğlu, asst. prof.
        • Sub-Investigator:
          • Nuray N Alaca, assoc. prof.

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

N/A

Sampling Method

Probability Sample

Study Population

100 patients diagnosed with chronic nonspecific low back pain (documented history of low back pain lasting more than twelve weeks without a recognizable, specific pathoanatomical cause of the pain) who applied to the Physical Therapy and Rehabilitation Polyclinic of the hospitals in the Acıbadem Health Group and the Physiotherapy and Rehabilitation Department of Avicenna Ataşehir Hospital will be included in the study. Diagnoses will be given by Health Physical Medicine and Rehabilitation Doctors with at least 20 years of experience. At the first meeting, eligible participants will be informed about the study, potential participants will be screened in terms of inclusion criteria, and verbal and written informed consent will be obtained from eligible participants by the Helsinki criteria.

Description

Inclusion Criteria:

  • Getting diagnosed with chronic non-specific low back pain
  • Being able to read and speak Turkish
  • Being between the ages of 18 and 65
  • Agreeing to participate in the research and signing the voluntary consent form.

Exclusion Criteria:

  • Presence of systemic disease
  • Cognitive impairment status (Mini-Mental State Examination <24),
  • Recent (<12 weeks) history of myocardial infarction, cerebrovascular accident
  • Presence of radiculopathy, infection, tumor, osteoporosis, vertebral fracture, trauma and surgery in the lumbar region
  • Having previously received any exercise therapy and/or training in pain neuroscience.
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: baseline and through study completion, an average of 4 weeks
Visual Analog Scale (VAS) is a pain rating scale used in clinical and research settings to measure the intensity or frequency of various symptoms. In the current study, VAS will be used to record participants' pain intensity. VAS consists of a single 10 cm line; The left end is described as "No pain" and the right end is described as "The most severe pain ever experienced". Patients will be asked to mark the severity of their current pain on a 10 cm line. When calculating, the marked point will be measured in cm. An increase in the score means that the intensity of the pain increases.
baseline and through study completion, an average of 4 weeks
Fear-Avoidance Beliefs Questionnaire
Time Frame: baseline and through study completion, an average of 4 weeks
Fear-Avoidance Beliefs Questionnaire is a tool used to assess fear-avoidance beliefs in patients with low back pain. In the current study, the fear and avoidance behaviors of the participants will be evaluated with FABQ. In the survey, which consists of sixteen questions and two subscales (physical activity and work), each question is scored on a six-point Likert scale (0: strongly disagree; 5: strongly agree). A high score in the evaluation is considered to indicate an increase in fear-avoidance behavior.
baseline and through study completion, an average of 4 weeks
Tampa Scale for Kinesiophobia
Time Frame: baseline and through study completion, an average of 4 weeks
The Tampa Scale for Kinesiophobia (TSK) will be used to assess participants' fear of movement. TSK is a 17-item scale developed to describe the fear of movement or re-injury. Each question is scored on a four-point Likert scale (1: strongly disagree; 4: strongly agree). The scoring of four items was reversed (items 4, 8, 12, and 16). Higher scores represent an increased fear of movement.
baseline and through study completion, an average of 4 weeks
The Pain Catastrophizing Scale
Time Frame: baseline and through study completion, an average of 4 weeks
The Pain Catastrophizing Scale will be used to assess participants' pain-related thoughts and feelings. It is self-administered and consists of 13 items and 3 subscales (helplessness, magnification, and rumination). It is scored using a five-point Likert-type scale (0: never; 4: always). High scores indicate high levels of catastrophizing.
baseline and through study completion, an average of 4 weeks
The Perceived Global Impact
Time Frame: through study completion, an average of 4 weeks
The Global Perceived Impact Scale (GAES) is the usual gold standard for assessing minimal clinically significant change associated with pain in a patient's subjective perception of improvement (global perceived impact). In the current study, the amount of improvement in symptoms perceived by the participants will be evaluated at the end of treatment with GAES. Participants were asked "How would you describe your current condition compared to the beginning of treatment?" question will be asked. They will be asked to rate on a seven-point Likert scale (1: no change or things have gotten worse; 7: much better, a significant improvement). A score of 6 or above will be chosen as the threshold for clinically significant improvement.
through study completion, an average of 4 weeks

Collaborators and Investigators

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

Sponsor

Acibadem University

Investigators

  • Principal Investigator: Elif E Safran, asst. prof., Acibadem University
  • Study Chair: Irmak I Çavuşoğlu, asst. prof., Acibadem University
  • Study Director: Nuray N Alaca, assoc. prof., 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 (Actual)

March 4, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

February 14, 2024

First Submitted That Met QC Criteria

February 14, 2024

First Posted (Actual)

February 21, 2024

Study Record Updates

Last Update Posted (Actual)

August 14, 2024

Last Update Submitted That Met QC Criteria

August 13, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-21-705

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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