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Recruiting NCT06271447

Answerability and Minimal Clinical Significance of the Pain Questionnaires

Observational Chronic Low-back Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Traditional therapy.
Who it may be relevant to
Registry conditions: Chronic Low-back Pain. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • Other Traditional therapy
    All participants will receive a 60-minute individual treatment program consisting of 16 sessions of routine physiotherapy aimed at reducing pain and improving function over four weeks. These treatments are already the patient's routine physiotherapy modalities. No changes will be made to the study. Since the questionnaires to be used in the study are related to fear of movement and pain, neuroscience education will be included in the treatment program of the patients. Patients will be informed

Primary outcome measures

  • Visual Analog Scale [Time frame: 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]
  • Tampa Scale for Kinesiophobia [Time frame: 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 Perceived Global Impact [Time frame: through study completion, an average of 4 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Elif Esma Safran — Istanbul

Identifiers

NCT: NCT06271447 · 2023-21-705

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗