Anxiety DisordersNCT06404788
Anxiety Level Among Patients With Chronic Low Back Pain
An observational study of Anxiety Disorders and Anxiety Disorders and Symptoms, run by Medical University of Silesia at 1 site in Poland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorders, Anxiety Disorders and Symptoms, Lower Back Pain
- How many people
- 202 participants
- Where
- 1 sitePoland
- Study dates
- 27 Nov 2024to 21 Apr 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult people with chronic low back pain waiting for consultation or physiotherpay intervention in primary care clinic or physiotherapy clinic.
Who may be able to join
- 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
Who cannot join
- trauma/ surgery on the low back within the past one year
- diagnosis of severe mental illness
- pregnant within the past one year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read the 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.
- Keywords
- chronic pain, low back pain, anxiety
- Medical subject headings
- Anxiety Disorders, Low Back Pain, Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start27 Nov 2024
- Primary completion31 Mar 2025
- Study completion21 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tomasz Jurys, Study chair, Department of Rehabilitation, Medical University of Silesia in Katowice, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404788
- Sponsor's protocol ID
- BNW/NWN/0052/KB/97/24
- Status last verified
- May 2024
- First submitted
- 1 May 2024
- Last updated
- 19 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiety Level Among Polish Patients With Chronic Low Back Pain: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06404788
- Acronym / sponsor ID
- BNW/NWN/0052/KB/97/24
- Keywords
- chronic pain, low back pain, anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 21 Apr 2025 (actual)
- First posted
- 8 May 2024 (actual)
- Results
- Posted 27 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult people with chronic low back pain waiting for consultation or physiotherpay intervention in primary care clinic or physiotherapy clinic.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- trauma/ surgery on the low back within the past one year
- diagnosis of severe mental illness
- pregnant within the past one year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Anxiety Disorders
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomasz Jurys study chair
Department of Rehabilitation, Medical University of Silesia in Katowice, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety Disorders and Anxiety Disorders and Symptoms, run by Medical University of Silesia at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire - Generalized Anxiety Disorder (GAD-7) Scale (time frame: up to 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.