Tailored Pain Guide (TPG) Study

Not Applicable

Recruiting

• Conditions: Chronic Lower Back Pain
• Interventions: Behavioral: Standard PainGuide; Behavioral: Structured and tailored PainGuide

• Registration Number: NCT05843890
• Lead Sponsor: University of Michigan

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.

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 Timeline

• Study First Submitted: 2023-04-24
• Study First Submitted QC: 2023-04-24
• Study First Posted: 2023-05-06
• Study Start: 2023-08-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01
• Primary Completion: 2027-02
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 550

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard PainGuide	Standard PainGuide	-
Structured and tailored PainGuide	Structured and tailored PainGuide	-

Primary Outcome Measures

Name	Time	Method
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference score	Baseline, Week 24	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

Secondary Outcome Measures

Name	Time	Method
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)	There is one question that participants select 0 (no pain) - 10 (worst imaginable pain).
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)	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.
Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive function	Baseline, Week 24 (initial group), Week 52 (NPP group)	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.
Change in pain interference based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0	Baseline, Week 24 (initial group), Week 52 (NPP group)	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.
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)	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.
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)	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.
Change in fatigue based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0	Baseline, Week 24 (initial group), Week 52 (NPP group)	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.
Change in sleep disturbance based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0	Baseline, Week 24 (initial group), Week 52 (NPP group)	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.
Change in ability to participate in social roles and activities based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0	Baseline, Week 24 (initial group), Week 52 (NPP group)	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.
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	Baseline, Week 52 (T5)	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States