Research Study on Patient Education for People With Chronic Low Back Pain
NCT Number: NCT06492642
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Low-back Pain
Interventions: OTHER: Patient Education for Chronic Low Back Pain
Sponsor: University of Pittsburgh
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2025-02-28
Locations: University of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States

Summary:
The goal of this pilot single-arm study is to examine the potential of personalized patient education materials to improve self-efficacy and perceived functional disability in patients with chronic low back pain. The main questions it aims to answer are:

1. What is the feasibility of delivering a personalized patient education program for individuals with chronic low back pain?
2. What is the impact of personalized patient education materials on disease-specific self-efficacy and patient-reported function in a small sample of individuals with chronic low back pain?

Participants will be asked to:

* access and complete online baseline questionnaires
* access and follow online patient materials on chronic low back pain on days 5, 8, 11, 14, and 17
* access and complete online follow-up responses to baseline questionnaires and a post-study survey

Primary Outcome Measures: Change from Baseline Personal Pain Beliefs on Pain Self-Efficacy Questionnaire (PSEQ) at Day 21, The PSEQ is a 10-item questionnaire that assesses an individual's confidence in performing specific functional activities despite ongoing pain. Reliability, validity, and internal consistency of the PSEQ have been established when used with patients with spine conditions. Possible scores range from 0-60 with higher scores indicating greater self-efficacy for managing pain.

Change= (Day 21 score - Baseline score), Baseline Day 0 & Day 21|Feasibility of delivering a personalized patient education program for individuals with chronic low back pain - Recruitment, - recruitment of at least 30 participants in 3 months, Through overall study completion, about 7 months|Feasibility of delivering a personalized patient education program for individuals with chronic low back pain - Retention, - retention of at least 80% of those participants through follow-up data collection, Through overall study completion, about 7 months|Feasibility of delivering a personalized patient education program for individuals with chronic low back pain - Missing Data, - missing data of no greater than 20% for any given data element, Through overall study completion, about 7 months
Secondary Outcome Measures: Change from Baseline Subjective Level of Disability on Oswestry Disability Index (ODI) at Day 21, In addition to using the ODI as an eligibility screening tool, the investigators will also use it as a secondary outcome to measure patient-reported physical function relative to LBP. The ODI is a 10-item questionnaire that is considered the gold standard of LBP functional outcome assessments. Possible scores range from 0 to 100 with higher scores indicating more severe disability caused by LBP.

Change= (Day 21 score - Baseline score), Baseline Day 0 & Day 21|Change from Baseline Pain on Numeric Pain Rating Scale (NPRS) at Day 21, The NPRS is a one item, 11-point tool that simply asks the user to rate their pain on a whole-number scale from 0 to 10. The investigators will ask participants to rate their average LBP over the last 24 hours. Possible scores range from 0 (no pain at all) to 10 (worst imaginable pain).

Change= (Day 21 score - Baseline score), Baseline Day 0 & Day 21