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Tailored PainGuide for Chronic Lower Back Pain

N/A

Recruiting

Led By Daniel Clauw, MD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.)

Be older than 18 years old

Must not have

Visual or hearing difficulties

Diagnosis of autoimmune disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 24

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if tailored digital interventions and a website like PainGuide can help people with chronic low back pain.

Who is the study for?

This trial is for people who have had lower back pain for at least six months, on more than half of those days, and experience significant disruption due to this pain. Participants must understand English and not be pregnant or breastfeeding. They can't join if they have cancer-related pain, autoimmune diseases, severe visual/hearing issues, or other conditions that the study leaders think would make them unsuitable.

What is being tested?

The study is testing two versions of an electronic self-management website called PainGuide: a standard version and one tailored to individual behaviors. It aims to see if the tailored guide helps reduce how much chronic low back pain interferes with daily activities more effectively.

What are the potential side effects?

Since this trial involves behavioral interventions through a digital platform rather than medication, traditional side effects are not expected. However, participants may experience discomfort from increased focus on their condition or frustration if no improvement in symptoms occurs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had lower back pain for at least six months, on most days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have problems with my sight or hearing.

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I have been diagnosed with an autoimmune disease.

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I am experiencing pain due to my cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

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

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

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