Tailored Pain Guide (TPG) Study

Chronic Lower Back Pain Clinical Trial

Official title:

Tailored Pain Guide (TPG) Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05843890
• Other study ID #: HUM00214375
• Status: Recruiting
• Phase: N/A
• Start date: August 18, 2023
• Est. completion date: February 2025

Study information

• Verified date: August 2023
• Source: University of Michigan
• Contact: Beth Banner
• Phone: 734-998-5837
• Email: eledward[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 430
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Lower Back Pain
• Low Back Pain

Intervention

Behavioral:
• Structured and tailored PainGuide
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).
• Standard PainGuide
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).

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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