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NCT Number: NCT05843890

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.

Recruiting

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Key information

Conditions

Chronic Lower Back Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Beth Banner

CONTACT

[email protected]

734-998-5837

Daniel Clauw, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

Treatment and study plan

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).

Primary outcomes

  1. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference score

    Time frame: 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 outcomes

  1. Change in pain intensity based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0

    Time frame: Baseline, Week 24 (initial group), Week 52 (NPP group)

    There is one question that participants select 0 (no pain) - 10 (worst imaginable pain).

  2. Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive function

    Time frame: 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.

  3. Change in the physical function based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0

    Time frame: 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.

  4. Change in anxiety based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0

    Time frame: 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.

  5. Change in depression based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0

    Time frame: 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.

  6. Change in fatigue based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0

    Time frame: 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.

  7. Change in sleep disturbance based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0

    Time frame: 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.

  8. Change in ability to participate in social roles and activities based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0

    Time frame: 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.

  9. Change in pain interference based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0

    Time frame: 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.

  10. 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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Beth Banner

CONTACT

[email protected]

734-998-5837

Sana Shaikh

CONTACT

[email protected]

734-763-5226

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
May 6, 2023
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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