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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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~months 2, 4, 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and months 2, 4, 6 for reporting.

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 more

Awards & 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.

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,439 Previous Clinical Trials
1,621,582 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,385 Previous Clinical Trials
652,312 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
867 Previous Clinical Trials
674,595 Total Patients Enrolled
~251 spots leftby Aug 2027