Health TrialsbyHealthPanel

Tailored Pain Guide (TPG) Study

ConditionChronic Lower Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Must be referred and currently on the waitlist for the NPP at the Back & Pain Center (BPC)

Disqualifiers

Current cancer related pain

Diagnosis of autoimmune disease

Unable to speak, write or read English

Visual or hearing difficulties

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • 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).

Treatment groups

550 Participants
are divided into 2 treatment groups
Group A: Structured and tailored PainGuideExperimental treatment 1 intervention
Group B: Standard PainGuideActive comparator 1 intervention

Trial outcomes

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

Time frame
Baseline, Week 24

Secondary outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan

Lead sponsor

Source ClinicalTrials.gov
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