Clinical trial NCT06492642: Research Study on Patient Education for People With Chronic Low Back Pain
Official title: Pilot Study of Personalized Patient Education for Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: Chronic Low-Back Pain
Patient Education
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 20 individuals with chronic low back pain. Will aim to recruit a socioeconomically diverse sample. No randomization or group assignment; analyses will be conducted using a pre-post design.
Primary purpose: TREATMENT

Brief 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

Detailed description: This is a pilot single-arm study to examine the potential of personalized patient education materials to improve self-efficacy and perceived functional disability for patients with chronic low back pain (cLBP).

The investigators aim to recruit 30 individuals with cLBP. The investigators will aim to recruit 15 individuals from areas with an Area Deprivation Index (ADI) of at least 6 and 15 from areas with an ADI of 5 or lower.

Participants will complete a 3-week educational intervention aimed at improving self-efficacy in managing chronic LBP. Educational materials will be personalized for each participant depending upon things like baseline knowledge of cLBP, smoking status, exercise status, beliefs about safe movement with cLBP, preference for various health care interventions, and nature of work (sedentary vs. labor-oriented job).

Educational materials will be provided electronically using Qualtrics.

Participants will complete outcome measures at baseline and follow-up as described elsewhere in this study record.

Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Existence of chronic low back pain, defined as back pain that has lasted longer than 12 weeks
* Has sought care for LBP within the past 12 months, confirmable through medical records
* Classified as having at least "moderate" LBP-related disability, defined as a raw score of 15 or higher (out of 50) on the Oswestry Disability Index (additional detail below in Outcomes) upon telephone screening

  * Patients who receive care through UPMC: The study team will confirm in Epic that the participant has indeed had a health care encounter that included a diagnosis of low back pain in the previous 12 months
  * Patients who receive care outside of UPMC: The potential participant can provide a physician letter, after visit summary, or other reasonable documentation to confirm that they have indeed sought health care for LBP within the previous 12 months
* (for 50% of participants) Area Deprivation Index (ADI) of 6 or higher, using the Pennsylvania-specific deciles. The investigators will use ADI as a marker of socioeconomic status. Although the sample size in this study will not be large enough to detect the ability of the intervention to reduce socioeconomic disparities in chronic LBP outcomes, the investigators do need to show that the investigators are able to recruit a sufficient population of individuals of lower socioeconomic status and individuals of higher socioeconomic status to demonstrate feasibility for a future larger study. State-level ADI is measured from 1 to 10, with lower scores indicating greater advantage, and higher scores indicating greater deprivation. It is measured at the level of a census block group. The investigators will identify a potential participant's ADI by inputting their address of residence into the Neighborhood Atlas mapping tool, which is freely available online at https://www.neighborhoodatlas.medicine.wisc.edu/mapping

Exclusion Criteria:

* any prior spine surgery
* any orthopaedic surgery in the past 6 months
* does not have own smartphone, tablet, laptop, or desktop to access study questionnaires and education materials

Primary outcomes:
measure: Change from Baseline Personal Pain Beliefs on Pain Self-Efficacy Questionnaire (PSEQ) at Day 21
timeFrame: Baseline Day 0 & Day 21
measure: Feasibility of delivering a personalized patient education program for individuals with chronic low back pain - Recruitment
timeFrame: Through overall study completion, about 7 months
measure: Feasibility of delivering a personalized patient education program for individuals with chronic low back pain - Retention
timeFrame: Through overall study completion, about 7 months
measure: Feasibility of delivering a personalized patient education program for individuals with chronic low back pain - Missing Data
timeFrame: Through overall study completion, about 7 months
Secondary outcomes:
measure: Change from Baseline Subjective Level of Disability on Oswestry Disability Index (ODI) at Day 21
timeFrame: Baseline Day 0 & Day 21
measure: Change from Baseline Pain on Numeric Pain Rating Scale (NPRS) at Day 21
timeFrame: Baseline Day 0 & Day 21
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Allyn Bove, PhD, PT, DPT
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Yanshan Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lewis M, Bromley K, Sutton CJ, McCray G, Myers HL, Lancaster GA. Determining sample size for progression criteria for pragmatic pilot RCTs: the hypothesis test strikes back! Pilot Feasibility Stud. 2021 Feb 3;7(1):40. doi: 10.1186/s40814-021-00770-x.