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

NCT06492642 | Completed

• 1 other identifier: STUDY24020023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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:

• 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

Conditions

Chronic Low-back Pain

Keywords

Chronic Low-Back Pain; Patient Education

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Change from Baseline Subjective Level of Disability on Oswestry Disability Index (ODI) at Day 21

  Baseline Day 0 & Day 21

• Change from Baseline Pain on Numeric Pain Rating Scale (NPRS) at Day 21

  Baseline Day 0 & Day 21

Study Arms (1)

Patient Education for Chronic Low Back Pain

EXPERIMENTAL

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

Interventions

Patient Education for Chronic Low Back Pain OTHER

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.

Patient Education for Chronic Low Back Pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• 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.

  PMID: 33536076 BACKGROUND

Related Links

• Neighborhood Atlas Mapping Tool

MeSH Terms

Interventions

Patient Education as Topic

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Allyn Bove, PhD, PT, DPT

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Yanshan Wang, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Physical Therapy

Model Details: 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.

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: July 9, 2024
• Study Start: September 5, 2024
• Primary Completion: January 21, 2025
• Study Completion: January 28, 2025
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)