NCT06404788

Brief 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 pain?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 8, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

November 27, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2025

Completed
1 year until next milestone

Results Posted

Study results publicly available

April 27, 2026

Completed
Last Updated

April 27, 2026

Status Verified

May 1, 2024

Enrollment Period

4 months

First QC Date

May 1, 2024

Results QC Date

September 18, 2025

Last Update Submit

April 23, 2026

Conditions

Keywords

chronic painlow back painanxiety

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult people with chronic low back pain waiting for consultation or physiotherpay intervention in primary care clinic or physiotherapy clinic.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehab-Med-I

Katowice, Silesian Voivodeship, 40-087, Poland

Location

MeSH Terms

Conditions

Anxiety DisordersLow Back PainChronic Pain

Condition Hierarchy (Ancestors)

Mental DisordersBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Tomasz Jurys
Organization
Department of Rehabilitation, Faculty of Health Sciences in Katowice, Medical University of Silesia in Katowice, Poland

Study Officials

  • Tomasz Jurys

    Department of Rehabilitation, Medical University of Silesia in Katowice, Poland

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2024

First Posted

May 8, 2024

Study Start

November 27, 2024

Primary Completion

March 31, 2025

Study Completion

April 21, 2025

Last Updated

April 27, 2026

Results First Posted

April 27, 2026

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations