Tailored Pain Guide (TPG) Study

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT05843890
Status
Recruiting
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Conditions

  • Chronic Lower Back Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Structured and tailored PainGuide — BEHAVIORAL
    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 PainGuide to capture movement data (daily step counts).
  • Standard PainGuide — BEHAVIORAL
    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).

Study Details

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.

Key Dates

Start date
Aug 18, 2023
Status verified
Mar 2026
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

Enrollment
550 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Structured and tailored PainGuide
  • Active Comparator: Standard PainGuide

Primary Outcome Measure

Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference score [ Time Frame: Baseline, Week 24 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Beth Banner
[email protected]
734-998-5837
Daniel Clauw, MD (PRINCIPAL_INVESTIGATOR)

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