Tailored Pain Guide (TPG) Study

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Lower Back Pain
• Intervention / Treatment: Behavioral: Structured and tailored PainGuide; Behavioral: Standard PainGuide

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.

• Study Type: Interventional
• Enrollment (Estimated): 550
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Beth Banner; Phone Number: 734-998-5837; Email: eledward@umich.edu
• Study Contact Backup: Name: Sana Shaikh; Phone Number: 734-763-5226; Email: skazi@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Beth Banner; Phone Number: 734-998-5837; Email: eledward@umich.edu
      • Principal Investigator: Daniel Clauw, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

  1. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Structured and tailored PainGuide	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 PainGuide to capture movement data (daily step counts).
Active Comparator: Standard PainGuide	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain intensity based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0	There is one question that participants select 0 (no pain) - 10 (worst imaginable pain).	Baseline, Week 24 (initial group), Week 52 (NPP group)
Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive function	There are 2 questions regarding cognitive function where participants select answers from not at all (1)-very mush (5) regarding cognitive function. There is a total of 10 points where higher scores mean higher 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	There are 4 questions that participants will select from without any difficulty (5) to unable to do (1). There are a total of 20 points where higher scores indicate higher physical function.	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	There are 4 questions that participants will select from never (1) to always (5). There are a total of 20 points where lower scores indicate lower levels of anxiety.	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	There are 4 questions that participants will select from never (1) to always (5). There are a total of 20 points where higher scores indicate higher levels of depression.	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	There are 4 questions that participants will select from not at all (1) to very much (5). There are a total of 20 points where higher scores indicate higher levels of fatigue.	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	There are 4 questions that participants will select from. Question 1 participants will select from Very poor (5) to very good. Questions 2-4 participants will select from not all (5) to very much (1). There are a total of 20 points where higher scores indicate higher sleep disturbances.	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	There are 4 questions that participants will select from never (5) to always (1). There are a total of 20 points where lower scores indicate more difficulty participating in social roles.	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	There are 4 questions that participants will select from not at all (1) to very much (5). There are a total of 20 points where lower scores indicate less pain interference.	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	There are 4 questions that participants will select from not at all (1) to very much (5). There are a total of 20 points where lower scores indicate less pain interference.	Baseline, Week 52 (T5)

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Daniel Clauw, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2023
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Surveys; Fitbit; Online resources
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: HUM00214375

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No