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.

Recruitment status

COMPLETED

Target enrollment

202 participants

Primary outcome timeframe

up to 10 months

Results posted on

2026-05-19

Participant Flow

Participant milestones

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

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 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.

Outcome measures

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 events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: +48 727 519 946

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place