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NCT Number: NCT06271447

Answerability and Minimal Clinical Significance of the Pain Questionnaires

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Elif Esma Safran

Istanbul, None Selected, 34752, Turkey (Türkiye)

Location status: Recruiting

Location contact

Elif E Safran, asst. prof.

CONTACT

[email protected]

500 4047 ext. 216

Elif E Safran, asst. prof.

PRINCIPAL_INVESTIGATOR

Irmak I Çavuşoğlu, asst. prof.

PRINCIPAL_INVESTIGATOR

Nuray N Alaca, assoc. prof.

CONTACT

[email protected]

500 4184 ext. Safran

Nuray N Alaca, assoc. prof.

SUB_INVESTIGATOR

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

traditional therapy

Other

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 about proper posture and movement regarding fear of movement and pain avoidance behaviors.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elif E Safran, asst. prof.

CONTACT

[email protected]

500 4047 ext. 216

Nuray N Alaca, assoc. prof.

CONTACT

[email protected]

500 4181 ext. 216

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Feb 21, 2024
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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