Clinical trial NCT05843890: Tailored Pain Guide (TPG) Study
Official title: Tailored Pain Guide (TPG) Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Lower Back Pain
Keywords: Online resources
Fitbit
Surveys
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference score
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Change in pain intensity based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0
timeFrame: Baseline, Week 24 (initial group), Week 52 (NPP group)
measure: Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive function
timeFrame: Baseline, Week 24 (initial group), Week 52 (NPP group)
measure: Change in the physical function based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0
timeFrame: Baseline, Week 24 (initial group), Week 52 (NPP group)
measure: Change in anxiety based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0
timeFrame: Baseline, Week 24 (initial group), Week 52 (NPP group)
measure: Change in depression based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0
timeFrame: Baseline, Week 24 (initial group), Week 52 (NPP group)
measure: Change in fatigue based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0
timeFrame: Baseline, Week 24 (initial group), Week 52 (NPP group)
measure: Change in sleep disturbance based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0
timeFrame: Baseline, Week 24 (initial group), Week 52 (NPP group)
measure: Change in ability to participate in social roles and activities based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0
timeFrame: Baseline, Week 24 (initial group), Week 52 (NPP group)
measure: Change in pain interference based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0
timeFrame: Baseline, Week 24 (initial group), Week 52 (NPP group)
measure: 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
timeFrame: Baseline, Week 52 (T5)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Daniel Clauw, MD
role: PRINCIPAL_INVESTIGATOR
References: