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Tailored Pain Guide (TPG) Study

Primary Purpose

Chronic Lower Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Structured and tailored PainGuide
Standard PainGuide
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lower Back Pain focused on measuring Online resources, Fitbit, Surveys

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. 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.

Sites / Locations

  • University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Structured and tailored PainGuide

Standard PainGuide

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
April 24, 2023
Last Updated
August 25, 2023
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT05843890
Brief Title
Tailored Pain Guide (TPG) Study
Official Title
Tailored Pain Guide (TPG) Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 18, 2023 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. The study hypothesizes that tailored digital interventions (plus using PainGuide) will demonstrate greater improvement in pain interference.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lower Back Pain
Keywords
Online resources, Fitbit, Surveys

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
430 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Structured and tailored PainGuide
Arm Type
Experimental
Arm Title
Standard PainGuide
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Structured and tailored PainGuide
Intervention Description
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. Participants will be asked to complete surveys over 24 weeks. All participants will also be registered with a Fitbit device that is linked to the PainGuide to capture movement data (daily step counts).
Intervention Type
Behavioral
Intervention Name(s)
Standard PainGuide
Intervention Description
Participants in the control group will not receive any messaging once enrolled. Participants will be asked to complete surveys over 24 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 Outcome Measure Information:
Title
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference score
Description
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 Outcome Measure Information:
Title
Change in pain intensity based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0
Description
There is one question that participants select 0 (no pain) - 10 (worst imaginable pain).
Time Frame
Baseline, Week 24
Title
Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive function
Description
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
Title
Change in the physical function based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0
Description
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
Title
Change in anxiety based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0
Description
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
Title
Change in depression based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0
Description
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.
Time Frame
Baseline, Week 24
Title
Change in fatigue based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0
Description
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.
Time Frame
Baseline, Week 24
Title
Change in sleep disturbance based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0
Description
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.
Time Frame
Baseline, Week 24
Title
Change in ability to participate in social roles and activities based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0
Description
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.
Time Frame
Baseline, Week 24
Title
Change in pain interference based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0
Description
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.
Time Frame
Baseline, Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beth Banner
Phone
734-998-5837
Email
eledward@umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sana Shaikh
Phone
734-763-5226
Email
skazi@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Clauw, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beth Banner
Phone
734-998-5837
Email
eledward@umich.edu
First Name & Middle Initial & Last Name & Degree
Daniel Clauw, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Tailored Pain Guide (TPG) Study

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