An interventional study of Structured and tailored PainGuide and Standard PainGuide in Chronic Lower Back Pain, sponsored by University of Michigan. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-09.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
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.
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.
University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Non-Pharma Sub-study:
Exclusion Criteria:
Behavioral: Structured and tailored PainGuide
Behavioral: Standard 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).
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).
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
Time frame: Baseline, Week 24
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).
Time frame: 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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
Time frame: Baseline, Week 52 (T5)
Plan to share: No
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