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Completed

NCT Number: NCT06404788

Anxiety Level Among Patients With Chronic Low Back Pain

The goal of this observational cross-sectional study is to learn about the intensity of anxiety symptoms among Polish people suffering from chronic lower back pain. The main question it aims to answer is:

What is the severity of anxiety symptoms among the Polish population of patients suffering from chronic lower back pain?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rehab-Med-I

Katowice, Silesian Voivodeship, 40-087, Poland

About this study

Chronic low back pain (CLBP) is among the most prevalent musculoskeletal disorders and is one of the leading causes of disability worldwide. Epidemiological data indicate that while most individuals will experience low back pain at some point in their lives, approximately 10-20% of these cases evolve into chronic conditions lasting longer than three months. The burden of CLBP extends beyond physical symptoms, as it is frequently associated with psychological comorbidities, most notably anxiety disorders. The biopsychosocial model of pain highlights the interrelated role of biological, psychological, and social factors in shaping the patient's pain experience and functional outcomes.

Anxiety symptoms have been consistently identified as amplifiers of pain perception, contributors to disability, and predictors of poor treatment response. Despite international evidence documenting high rates of anxiety in CLBP populations, there is a paucity of data from Poland. This study therefore aims to evaluate the severity of generalized anxiety symptoms in a Polish cohort of patients with CLBP and to investigate sociodemographic and clinical factors potentially associated with anxiety severity.

The study was designed as a cross-sectional observational investigation, conducted at the NZOZ REHABMED-I rehabilitation clinic in Katowice, Poland. Participants were adults aged 18 years or older, with CLBP persisting longer than three months, fluent in Polish, and willing to provide informed consent. Exclusion criteria included recent spinal trauma or surgery, severe psychiatric illness, and pregnancy in the past year. A total of 202 participants were recruited, surpassing the required minimum calculated sample size (n = 196).

Data collection involved completion of the Generalized Anxiety Disorder 7-item scale (GAD-7), supplemented with questions on demographics, pain duration, and comorbidities. Statistical analyses included descriptive summaries, Pearson correlations, independent-sample t-tests, and one-way ANOVA to evaluate associations between anxiety severity and age, gender, education, work type, pain duration, and comorbidities.

Preliminary results demonstrated that nearly half of participants reported clinically relevant anxiety (mild to severe). Comorbidities emerged as the most robust correlate of higher anxiety scores, while gender, education, work type, and pain duration did not show significant associations. These findings highlight the importance of integrating psychological screening into the management of CLBP, particularly for patients with comorbid conditions.

The study contributes to growing international evidence that CLBP should be addressed through a biopsychosocial approach, where both physical and psychological dimensions are routinely assessed and treated. Implementation of targeted interventions such as cognitive-behavioral therapy and acceptance-based strategies may improve outcomes, reduce disability, and enhance quality of life in this patient population.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age minimum 18 years old
  • chronic low back pain (duration longer than 3 months)
  • native Polish speaker
  • people who gave informed consent to participate in the study

Exclusion criteria

  • trauma/ surgery on the low back within the past one year
  • diagnosis of severe mental illness
  • pregnant within the past one year

Treatment and study plan

Primary outcomes

  1. Questionnaire - Generalized Anxiety Disorder (GAD-7) Scale

    Time frame: up to 10 months

    The questionnaire consists of seven items, which are assessed on a four-point Likert scale (0-3) measuring the severity of various symptoms (21 points in total) 0-4: No or minimal anxiety symptoms. The person does not experience significant anxiety, or if they do, it is sporadic and not burdensome.

    5-9: Mild anxiety. The person experiences moderate anxiety that may affect daily functioning, but it is not too severe or long-lasting.

    10-14: Moderate anxiety. The person experiences severe anxiety, which may interfere with daily activities and require some adaptation. Somatic symptoms such as muscle tension or sleep problems may also occur.

    15-21: Severe anxiety. The person experiences intense and debilitating anxiety that significantly impairs daily functioning and may require professional intervention.

    Minimum values: 0 points Maximum values: 21 points The higher the number of points, the greater the severity of the symptoms.

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Registry information

Official study title

Anxiety Level Among Polish Patients With Chronic Low Back Pain: a Cross-sectional Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 8, 2024
Registry last updated
May 19, 2026

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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