Trial Outcomes & Findings for Anxiety Level Among Patients With Chronic Low Back Pain (NCT NCT06404788)
NCT ID: NCT06404788
Last Updated: 2026-05-19
Results Overview
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.
COMPLETED
202 participants
up to 10 months
2026-05-19
Participant Flow
Participant milestones
| Measure |
Adults With Diagnosed Chronic Low Back Pain
Adults with diagnosed chronic low back pain (with pain duration longer than 3 months)
|
|---|---|
|
Overall Study
STARTED
|
202
|
|
Overall Study
COMPLETED
|
202
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Adults With Diagnosed Chronic Low Back Pain
n=202 Participants
Adults with diagnosed chronic low back pain (with pain duration longer than 3 months)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=202 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
136 Participants
n=202 Participants
|
|
Age, Categorical
>=65 years
|
66 Participants
n=202 Participants
|
|
Age, Continuous
|
56.2 years
STANDARD_DEVIATION 13.5 • n=202 Participants
|
|
Sex: Female, Male
Female
|
129 Participants
n=202 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=202 Participants
|
|
Region of Enrollment
Poland
|
202 participants
n=202 Participants
|
|
GAD-7 results
|
5.53 units on a scale
STANDARD_DEVIATION 5.07 • n=202 Participants
|
PRIMARY outcome
Timeframe: up to 10 monthsThe 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.
Outcome measures
| Measure |
Adults With Diagnosed Chronic Low Back Pain
n=202 Participants
Adults with diagnosed chronic low back pain (with pain duration longer than 3 months)
|
|---|---|
|
Questionnaire - Generalized Anxiety Disorder (GAD-7) Scale
|
5.53 score on a scale
Standard Deviation 5.07
|
Adverse Events
Adults With Diagnosed Chronic Low Back Pain
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Tomasz Jurys
Department of Rehabilitation, Faculty of Health Sciences in Katowice, Medical University of Silesia in Katowice, Poland
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place