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Community Supported Self-Management Programs for Back Pain
N/A
Waitlist Available
Led By Brent Leininger, PhD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months
Awards & highlights
Study Summary
This trial will work to create better self-care programs for back/neck pain in underserved populations. Community input will be used to develop/test & evaluate.
Who is the study for?
This trial is for adults over 18 with chronic back or neck pain lasting more than 3 months, scoring at least a 3 on the PEG scale. It's aimed at those in health disparity groups such as certain ethnic minorities or people with low income. Excluded are individuals undergoing cancer treatment, hospitalized for severe mental illness recently, pregnant women, children under 18, and those with dementia or recent severe psychiatric symptoms.Check my eligibility
What is being tested?
The study tests two community-based self-management programs for chronic back/neck pain: Partners4Pain and Key to Wellbeing. The goal is to see how well these programs work for people from underserved communities. Participants will be randomly assigned to one of the programs to assess their effectiveness.See study design
What are the potential side effects?
Since this trial involves non-pharmaceutical interventions like mindfulness and physical exercises rather than medication, side effects may include discomfort during exercises or emotional distress due to mind-body practices but are generally expected to be minimal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Data Collection Feasibility
Intervention Delivery Feasibility
Intervention Fidelity
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Partners4Pain programExperimental Treatment1 Intervention
adults with chronic neck or back pain from populations that experience health disparities due to race/ethnicity or socioeconomic status
Group II: Key to Wellbeing programActive Control1 Intervention
adults with chronic neck or back pain from populations that experience health disparities due to race/ethnicity or socioeconomic status
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Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,388 Previous Clinical Trials
1,552,776 Total Patients Enrolled
Brent Leininger, PhDPrincipal InvestigatorUniversity of Minnesota
Roni Evans, PhDPrincipal InvestigatorUniversity of Minnesota
1 Previous Clinical Trials
30 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been hospitalized for a serious mental illness in the past six months, as the experimental practices may make your symptoms worse.You are currently receiving radiation or chemotherapy for cancer, which could affect your back or neck pain and health during the study.Your pain, enjoyment of life, and general activity score is 3 or higher on a scale from 0 to 10.You are part of a group that has been identified as having less access to healthcare or being at higher risk for certain diseases by the National Institutes of Health. This includes American Indian/Alaska Native, Asian, Black/African American, Hispanic/Latino, Native Hawaiian/Pacific Islanders, and people with low income (earning less than $50,000 per year).You have experienced severe mental health symptoms like seeing or hearing things that aren't there, thinking about harming yourself, or feeling extremely high and impulsive in the past three months.You have trouble remembering things or following instructions for safe physical activities.You cannot participate if you are pregnant because back pain during pregnancy is different and may affect the study results differently.You have been experiencing back or neck pain for 3 months or more.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Partners4Pain program
- Group 2: Key to Wellbeing program
Lower Back Pain Patient Testimony for trial: Trial Name: NCT05786508 — N/A
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