Tailored Pain Guide (TPG) Study

Study Overview
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Brief Summary
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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.

Official Title
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Tailored Pain Guide (TPG) Study

Conditions
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Chronic Lower Back Pain

Intervention / Treatment
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* Behavioral: Structured and tailored PainGuide
* Behavioral: Standard PainGuide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Structured and tailored PainGuide<br> | Behavioral: Structured and tailored PainGuide<br>* 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).<br>|
| Active Comparator: Standard PainGuide<br> | Behavioral: Standard PainGuide<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline, Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline, Week 24 | 
| 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. | Baseline, Week 24 | 
| 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. | Baseline, Week 24 | 
| 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. | Baseline, Week 24 | 
| 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. | Baseline, Week 24 | 
| 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. | Baseline, Week 24 | 
| 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. | Baseline, Week 24 | 
| 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. | Baseline, Week 24 | 
| 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. | Baseline, Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Online resources, Fitbit, Surveys