- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06404788
Anxiety Level Among Patients With Chronic Low Back Pain
Anxiety Level Among Polish Patients With Chronic Low Back Pain: a Cross-sectional Study
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?
Study Overview
Status
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Silesian Voivodeship
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Katowice, Silesian Voivodeship, Poland, 40-087
- Rehab-Med-I
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Questionnaire - Generalized Anxiety Disorder (GAD-7) Scale
Time Frame: up to 10 months
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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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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Tomasz Jurys, Department of Rehabilitation, Medical University of Silesia in Katowice, Poland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BNW/NWN/0052/KB/97/24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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