Clinical trial NCT03909048: Chronic Low Back Pain Graded - Exposure Psychoeducation Intervention
Official title: Chronic Low Back Pain Graded - Exposure Psychoeducation Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Chronic Pain
Low Back Pain
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine the effectiveness of one of two psychoeducation treatments on chronic low back pain.

Detailed description: This study will examine the effectiveness of one of two psychoeducation treatments on chronic low back pain. Participants will be randomized to one of these two treatments.

Eligibility criteria: Inclusion Criteria:

* report having low back pain for more than three months and at least half the days in the past 6 months
* be 18-65 years of age,
* have scores higher than 37 on the Tampa Scale of Kinesiophobia,

Exclusion Criteria:

* medical conditions other than back pain that significantly impair movement (e.g., arthritis)
* confirmed/suspected pregnancy
* pending litigation related to an episode of low back pain
* significant impairment in vision

Primary outcomes:
measure: Pain Intensity as assessed by Numeric Rating Scale
timeFrame: Baseline - Final assessment (average 1 week post treatment)
measure: Present Pain Intensity
timeFrame: Baseline - Final assessment (average 1 week post treatment)
measure: Present Pain Rating
timeFrame: Baseline - Final assessment (average 1 week post treatment)
measure: Pain Chronicity assessed by the Graded Chronic Pain Scale
timeFrame: Baseline - Final assessment (average 1 week post treatment)
measure: Daily Pain Monitoring: 10 point scale
timeFrame: Baseline - Final assessment (average 1 week post treatment)
Secondary outcomes:
measure: Back Disability as assessed by the Roland Morris Disability Questionnaire
timeFrame: Baseline - Final assessment (average 1 week post treatment)
measure: Depressive symptoms as assessed by the Center for Epidemiologic Studies Depression Scale
timeFrame: Baseline - Final assessment (average 1 week post treatment)
measure: Pain Catastrophizing as assessed by the Pain Catastrophizing Scale
timeFrame: Baseline - Final assessment (average 1 week post treatment)
measure: Pain-related fear of movement as assessed by the Tampa Scale Kinesiophobia
timeFrame: Baseline - Final assessment (average 1 week post treatment)
measure: Mood and Affect as assessed by the Positive and Negative Affect Scale
timeFrame: Baseline - Final assessment (average 1 week post treatment)
measure: Immersive Tendencies
timeFrame: Baseline only
measure: Absorption Tendencies
timeFrame: Baseline Only
measure: Video Game History
timeFrame: Baseline Only
measure: Patient Treatment Evaluation as assessed by the Modified Treatment Evaluation Inventory
timeFrame: Final assessment (average 1 week post treatment)
measure: Patient Treatment Evaluation as assessed by Semi-structured Qualitative interviewing
timeFrame: Final assessment (average 1 week post treatment)
measure: Daily intervention feedback questions
timeFrame: Baseline - Final assessment (average 1 week post treatment)
measure: Patient Treatment Evaluation as assessed by the Usefulness, Satisfaction, and Ease of Use Questionnaire
timeFrame: Final assessment (average 1 week post treatment)
measure: Patient Treatment Evaluation as assessed by the Patient Global Impression of Change Scale
timeFrame: Final assessment (average 1 week post treatment)
measure: Video Game Preferences as assessed by the BrainHex
timeFrame: Final assessment (average 1 week post treatment)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References: