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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?
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire - Generalized Anxiety Disorder (GAD-7) Scale | 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. | up to 10 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adult people with chronic low back pain waiting for consultation or physiotherpay intervention in primary care clinic or physiotherapy clinic.
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| Name | Affiliation | Role |
|---|---|---|
| Tomasz Jurys | Department of Rehabilitation, Medical University of Silesia in Katowice, Poland | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehab-Med-I | Katowice | Silesian Voivodeship | 40-087 | Poland |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adults With Diagnosed Chronic Low Back Pain | Adults with diagnosed chronic low back pain (with pain duration longer than 3 months) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adults With Diagnosed Chronic Low Back Pain | Adults with diagnosed chronic low back pain (with pain duration longer than 3 months) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Questionnaire - Generalized Anxiety Disorder (GAD-7) Scale | 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. | Posted | Mean | Standard Deviation | score on a scale | up to 10 months |
|
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adults With Diagnosed Chronic Low Back Pain | Adults with diagnosed chronic low back pain (with pain duration longer than 3 months) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tomasz Jurys | Department of Rehabilitation, Faculty of Health Sciences in Katowice, Medical University of Silesia in Katowice, Poland | +48 727 519 946 | tomasz.jurys@sum.edu.pl |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 17, 2025 | Aug 17, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D017116 | Low Back Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| GAD-7 results | Mean | Standard Deviation | units on a scale |
|
| Adults With Diagnosed Chronic Low Back Pain |
Adults with diagnosed chronic low back pain (with pain duration longer than 3 months) |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |