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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 24

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Structured and tailored PainGuideExperimental Treatment1 Intervention

Group II: Standard PainGuideActive Control1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,798 Previous Clinical Trials

6,377,708 Total Patients Enrolled

Daniel Clauw, MDPrincipal InvestigatorUniversity of Michigan

3 Previous Clinical Trials

692 Total Patients Enrolled

Media Library

Standard PainGuide Clinical Trial Eligibility Overview. Trial Name: NCT05843890 — N/A

Chronic Lower Back Pain Research Study Groups: Standard PainGuide, Structured and tailored PainGuide

Chronic Lower Back Pain Clinical Trial 2023: Standard PainGuide Highlights & Side Effects. Trial Name: NCT05843890 — N/A

Standard PainGuide 2023 Treatment Timeline for Medical Study. Trial Name: NCT05843890 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment phase of this trial ongoing?

"According to the available information on clinicaltrials.gov, this medical trial is presently not enrolling participants. First posted on May 1st 2023 and last edited April 24th 2023, the study has ceased recruitment for now. However, there are other trials ongoing that may accept patients; 292 of them in fact."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tailored Pain Guide (TPG) Study

Daniel Clauw, MD 2023. "Tailored Pain Guide (TPG) Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05843890.

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