Research Study on Patient Education for People With Chronic Low Back Pain

March 5, 2025 updated by: Allyn Bove, University of Pittsburgh

Pilot Study of Personalized Patient Education for Chronic Low Back Pain

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient Education for Chronic Low Back Pain
Patients will access online patient education materials on chronic low back pain five times after completing baseline questionnaires on days 5, 8, 11, 14, and 17.
Other: Patient Education for Chronic Low Back Pain

Patient education on chronic low back pain (LBP), including:

Day 5: Basic LBP education, types of LBP, "red flags"; Day 8: LBP guideline recommendations re: imaging; Day 11: LBP guideline recommendations re: use of rehabilitation services, sitting and standing desks; Day 14: LBP guideline recommendations re:pharmacologic management; Day 17: LBP guideline recommendations re: injections and surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Personal Pain Beliefs on Pain Self-Efficacy Questionnaire (PSEQ) at Day 21
Time Frame: Baseline Day 0 & 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
Time Frame: Through overall study completion, about 7 months
- 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
Time Frame: Through overall study completion, about 7 months
- 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
Time Frame: Through overall study completion, about 7 months
- missing data of no greater than 20% for any given data element
Through overall study completion, about 7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Subjective Level of Disability on Oswestry Disability Index (ODI) at Day 21
Time Frame: Baseline Day 0 & 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
Time Frame: Baseline Day 0 & 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: Allyn Bove, PhD, PT, DPT, University of Pittsburgh
  • Principal Investigator: Yanshan Wang, PhD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2024

Primary Completion (Actual)

January 21, 2025

Study Completion (Actual)

January 28, 2025

Study Registration Dates

First Submitted

June 21, 2024

First Submitted That Met QC Criteria

July 1, 2024

First Posted (Actual)

July 9, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 5, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY24020023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No current plan to share IPD with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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