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Chronic Low-back PainNCT06492642

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

A study testing Patient Education for Chronic Low Back Pain in people with Chronic Low-back Pain, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Low-back Pain
What is being tested?
Patient Education for Chronic Low Back Pain
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
5 Sep 2024to 28 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: 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?
Read more

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
Read the 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.

Being tested
Patient Education for Chronic Low Back Pain
Keywords
Chronic Low-Back Pain, Patient Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient Education for Chronic Low Back PainOther

    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.

Study groups in NCT06492642
Study groupRoleWhat they receive
Patient Education for Chronic Low Back PainExperimentalPatients 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.
Receives: Other: Patient Education for Chronic Low Back Pain

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Baseline Day 0 & Day 21

  2. 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

    Measured: Through overall study completion, about 7 months

  3. 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

    Measured: Through overall study completion, about 7 months

  4. 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

    Measured: Through overall study completion, about 7 months

Secondary outcomes (2)

  1. 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)

    Measured: Baseline Day 0 & Day 21

  2. 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)

    Measured: Baseline Day 0 & Day 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2024
  2. Study start5 Sep 2024
  3. Primary completion21 Jan 2025
  4. Study completion28 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06492642
Sponsor's protocol ID
STUDY24020023
Status last verified
Mar 2025
First submitted
21 Jun 2024
Last updated
6 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No current plan to share IPD with other researchers.

Publications

  • 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.

    PubMed 33536076

Questions about this trial

What is this clinical trial studying?

A study testing Patient Education for Chronic Low Back Pain in people with Chronic Low-back Pain, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Personal Pain Beliefs on Pain Self-Efficacy Questionnaire (PSEQ) at Day 21 (time frame: Baseline Day 0 & Day 21). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06492642, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.

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