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Recruiting NCT05843890

Tailored Pain Guide (TPG) Study

No phase Interventional Chronic Lower Back Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Structured and tailored PainGuide, Standard PainGuide.
Who it may be relevant to
Registry conditions: Chronic Lower Back Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This research is studying whether changing an individual's behaviors may have an impact as a treatment or outcome for chronic low back pain. This research will try to understand how much an electronic, self-management website like PainGuide can help participants. The study hypothesizes that tailored digital interventions (plus using PainGuide) will demonstrate greater improvement in pain interference.

Detailed description

There was an amendment approved by the University of Michigan Medical School Institutional Review Board (AME00158411). This amendment included the following:

increased enrollment numbers, updated recruitment procedures including the Non-Pharma Program (NPP) Sub-Study, as well as changes in time frames.

Interventions

  • Behavioral Structured and tailored PainGuide
    Participants will receive specific instruction to complete one module a week over the first 4 weeks. Participants will then receive tailored messaging using scores from the assessments completed during T1(baseline visit) from the PROMIS 29+2. The initial group of participants (prior to AME00158411) will complete surveys for 24 weeks. The NPP Participants will be asked to complete surveys for 52 weeks. All participants will also be registered with a Fitbit device that is linked to the PainGuid
  • Behavioral Standard PainGuide
    Participants in the control group will not receive any messaging once enrolled. The initial group of participants (prior to AME00158411) will complete surveys for 24 weeks. The NPP Participants will be asked to complete surveys for 52 weeks. All participants will also be registered with a Fitbit device that is linked to the PainGuide to capture movement data (daily step counts).

Primary outcome measures

  • Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference score [Time frame: Baseline, Week 24]
Secondary outcome measures (10)
  • Change in pain intensity based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0 [Time frame: Baseline, Week 24 (initial group), Week 52 (NPP group)]
  • Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive function [Time frame: Baseline, Week 24 (initial group), Week 52 (NPP group)]
  • Change in the physical function based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0 [Time frame: Baseline, Week 24 (initial group), Week 52 (NPP group)]
  • Change in anxiety based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0 [Time frame: Baseline, Week 24 (initial group), Week 52 (NPP group)]
  • Change in depression based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0 [Time frame: Baseline, Week 24 (initial group), Week 52 (NPP group)]
  • Change in fatigue based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0 [Time frame: Baseline, Week 24 (initial group), Week 52 (NPP group)]
  • Change in sleep disturbance based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0 [Time frame: Baseline, Week 24 (initial group), Week 52 (NPP group)]
  • Change in ability to participate in social roles and activities based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0 [Time frame: Baseline, Week 24 (initial group), Week 52 (NPP group)]
  • Change in pain interference based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0 [Time frame: Baseline, Week 24 (initial group), Week 52 (NPP group)]
  • Change in pain interference based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0 - between baseline and 52 weeks for NPP participants [Time frame: Baseline, Week 52 (T5)]

Eligibility criteria

Inclusion criteria

  • Chronic Lower Back pain (cLBP) defined by the National Institutes of Health (NIH) Task Force Report on Research Standards for Chronic Low Back Pain, (i.e., low back pain present at least six months, and present more than half of those days.)
  • Individuals must have a score of greater or equal to (≥) 60 on PROMIS Pain Interference.
  • Non-Pharma Sub-study:
  • Must be referred and currently on the waitlist for the NPP at the Back \& Pain Center (BPC)

Exclusion criteria

  • Current cancer related pain
  • Diagnosis of autoimmune disease
  • Unable to speak, write or read English
  • Visual or hearing difficulties
  • Pregnancy or breastfeeding
  • Any other diseases or conditions that would make a patient unsuitable for study participation as determined by the site principal investigators.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Michigan — Ann Arbor

Identifiers

NCT: NCT05843890 · HUM00214375

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗