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Behavioral Intervention
Self-Management Programs for Chronic Back and Neck Pain (P4P Trial)
N/A
Recruiting
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years of age or older
Be older than 18 years old
Must not have
Self-reported cancer with active treatment involving radiation or chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 2, 4, 6
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see how well two community-based self-management programs work for people with chronic back or neck pain from minoritized populations. The study will compare a program teaching mind-body skills like mindfulness and
Who is the study for?
This trial is for individuals from underrepresented communities based on race, ethnicity, or income who suffer from chronic back or neck pain. Participants will be screened to ensure they meet the study's requirements and must commit to attending weekly sessions and completing several surveys.
What is being tested?
The trial compares two self-management programs: Partners4Pain, which teaches mind-body skills like mindfulness and cognitive behavioral strategies; versus Keys to Wellbeing, focusing on general health. The effectiveness in reducing pain intensity and its impact on life activities will be measured.
What are the potential side effects?
Since the interventions are non-pharmaceutical community-based self-management programs focused on teaching skills for managing pain and improving wellbeing, significant side effects are not anticipated.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently undergoing radiation or chemotherapy for my cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ months 2, 4, 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 2, 4, 6
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain, Interference with Enjoyment of Life and General Activity
Secondary study objectives
Adverse Events
Anxiety
Complementary Integrative Health Self-Management Use
+17 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Partners4PainExperimental Treatment1 Intervention
Community-based program that focuses on evidence based mind-body tools (mindfulness, cognitive behavioral approaches) for pain self-management in addition to pain education and physical exercises.
Group II: Keys to WellbeingActive Control1 Intervention
Community-based program that focuses on general health and well-being education for pain self-management in addition to pain education and physical exercises.
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Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,434 Previous Clinical Trials
1,621,326 Total Patients Enrolled
4 Trials studying Back Pain
1,131 Patients Enrolled for Back Pain
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,378 Previous Clinical Trials
651,816 Total Patients Enrolled
6 Trials studying Back Pain
601 Patients Enrolled for Back Pain
National Center for Complementary and Integrative Health (NCCIH)NIH
858 Previous Clinical Trials
671,935 Total Patients Enrolled
51 Trials studying Back Pain
263,436 Patients Enrolled for Back Pain
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