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Chronic Lower Back PainNCT05843890

Tailored Pain Guide (TPG) Study

A study testing Structured and tailored PainGuide and Standard PainGuide in people with Chronic Lower Back Pain, run by University of Michigan at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lower Back Pain
What is being tested?
Structured and tailored PainGuide and Standard PainGuide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
550 participants
Where
1 siteUnited States
Study dates
18 Aug 2023to Feb 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Beth Banner contact

734-998-5837

eledward@umich.edu

Sana Shaikh contact

734-763-5226

skazi@med.umich.edu

United States1 site, 1 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Beth Banner, 734-998-5837, eledward@umich.edu

    Daniel Clauw, MD

    Recruiting

Other trials in United States

About this 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.

Read the 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.

Being tested
Structured and tailored PainGuide, Standard PainGuide
Keywords
Online resources, Fitbit, Surveys

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Structured and tailored PainGuideBehavioural

    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 PainGuideBehavioural

    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).

Study groups in NCT05843890
Study groupRoleWhat they receive
Structured and tailored PainGuideExperimentalNot described
Receives: Behavioral: Structured and tailored PainGuide
Standard PainGuideActive comparatorNot described
Receives: Behavioral: Standard PainGuide

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline, Week 24

Secondary outcomes (10)

  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).

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Baseline, Week 24 (initial group), Week 52 (NPP group)

  5. 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.

    Measured: Baseline, Week 24 (initial group), Week 52 (NPP group)

  6. 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.

    Measured: Baseline, Week 24 (initial group), Week 52 (NPP group)

  7. 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.

    Measured: Baseline, Week 24 (initial group), Week 52 (NPP group)

  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

    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.

    Measured: Baseline, Week 24 (initial group), Week 52 (NPP group)

  9. 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.

    Measured: Baseline, Week 24 (initial group), Week 52 (NPP group)

  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

    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.

    Measured: Baseline, Week 52 (T5)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2023
  2. Study start18 Aug 2023
  3. Primary completionFeb 2028 (estimated)
  4. Study completionFeb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
550 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05843890
Sponsor's protocol ID
HUM00214375
Status last verified
Mar 2026
First submitted
24 Apr 2023
Last updated
9 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Structured and tailored PainGuide and Standard PainGuide in people with Chronic Lower Back Pain, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Beth Banner (734-998-5837, eledward@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference score (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05843890.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.

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