Tailored Pain Guide (TPG) Study

NCT05843890 | Recruiting

• 1 other identifier: HUM00214375
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Lower Back Pain

Keywords

Online resources; Fitbit; Surveys

Outcome Measures

Primary Outcomes (1)

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference score

  The PROMIS Pain Interference consists of 4-items that assess the degree to which pain interferes with various aspects of life. Items are scored on a 1 ("Not at all") to 5 ("Very much") scale with a range of 4 - 20. Higher scores indicate greater pain interference

  Baseline, Week 24

Secondary Outcomes (10)

• Change in pain intensity based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0

  Baseline, Week 24 (initial group), Week 52 (NPP group)

• Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive function

  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

  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

  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

  Baseline, Week 24 (initial group), Week 52 (NPP group)

Study Arms (2)

Structured and tailored PainGuide

EXPERIMENTAL

Behavioral: Structured and tailored PainGuide

Standard PainGuide

ACTIVE COMPARATOR

Behavioral: Standard PainGuide

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).

Structured and tailored PainGuide

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).

Standard PainGuide

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Study Officials

• Daniel Clauw, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beth Banner

CONTACT

734-998-5837; eledward@umich.edu

Sana Shaikh

CONTACT

734-763-5226; skazi@med.umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Model Details: The initial study enrolled 297 participants. Following the amendment (AME00158411) the study team will now enroll the non-pharma program to this project. The anticipated enrollment number was increased from 430 to 550.

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 6, 2023
• Study Start: August 18, 2023
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)