Clinical trial NCT06271447: Answerability and Minimal Clinical Significance of the Pain Questionnaires
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Low-back Pain
Keywords: Chronic Low Back Pain
pain management
rehabilitation
minimal clinical significance
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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

Primary outcomes:
measure: Visual Analog Scale
timeFrame: baseline and through study completion, an average of 4 weeks
measure: Fear-Avoidance Beliefs Questionnaire
timeFrame: baseline and through study completion, an average of 4 weeks
measure: Tampa Scale for Kinesiophobia
timeFrame: baseline and through study completion, an average of 4 weeks
measure: The Pain Catastrophizing Scale
timeFrame: baseline and through study completion, an average of 4 weeks
measure: The Perceived Global Impact
timeFrame: through study completion, an average of 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Elif Esma Safran
state: None Selected
Study officials:
affiliation: Acibadem University
name: Elif E Safran, asst. prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Acibadem University
name: Irmak I Çavuşoğlu, asst. prof.
role: STUDY_CHAIR
affiliation: Acibadem University
name: Nuray N Alaca, assoc. prof.
role: STUDY_DIRECTOR
References: