Partners for Pain & Wellbeing Equity: A Randomized Trial of Community Supported Complementary and Integrative Health Self-management for Back Pain

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Primary Purpose

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Partners4Pain program

Key to Wellbeing program

About this trial

This is an interventional supportive care trial for Neck Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Provide a signed and dated informed consent form State willingness to comply with all study procedures outlined in the consent form Be 18 years of age or older Have self-reported chronic back pain (defined as pain in the low or mid back, or neck pain) which has lasted for 3 months or longer Have a score of 3 or higher on the self-reported Pain, Enjoyment of Life and General Activity (PEG) scale (0 to 10) Be a member of one or more of the following NIH-designated health disparity populations: American Indian/Alaska Native, Asian, Black/African American, Hispanic/Latino, Native Hawaiian/Pacific Islanders, Socioeconomically disadvantaged (annual household income less than $50,000) Exclusion Criteria: Hospitalization for severe mental illness in past six months because the mindfulness and behavioral mind-body practices (e.g., meditation, progressive muscle relaxation, etc.) in the experimental intervention may aggravate symptoms of severe mental illness Active psychotic symptoms, suicidal ideation, or manic episodes in the past three months for the same reasons noted in #1 Self-reported cancer with active treatment involving radiation or chemotherapy due to the potential for complications of their back or neck pain and impact on health outcomes Dementia - Mini Mental State Exam score of 23 or lower for those with suspicion of cognitive impairment due to safety risks (e.g., not being able to follow directions for safe physical exercise) Self-reported pregnancy due to the fact that back pain is often associated with pregnancy and differs from non-pregnancy related back pain and thus might have different impacts on health outcomes Children under the age of 18

Sites / Locations

University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Partners4Pain program

Key to Wellbeing program

Arm Description

adults with chronic neck or back pain from populations that experience health disparities due to race/ethnicity or socioeconomic status

Outcomes

Primary Outcome Measures

Participant Recruitment

Demonstrate the ability to recruit and retain subjects in the clinical study as follows: Randomize at least 30 participants

Participant Recruitment

Demonstrate the ability to recruit and retain subjects in the clinical study as follows: 75% or more of randomized participants are from NIH-defined racial/ethnic health disparity groups;

Participant Retention Feasibility

Demonstrate the ability to recruit and retain subjects in the clinical study as follows: 80% or more of randomized participants are retained for primary outcome measurement at the end of the study (2 month follow up) regardless of adherence to the intervention

Intervention Delivery Feasibility

Demonstrate that the delivery of the intervention(s) and the control intervention(s) under study can be delivered consistently, as defined by: 85% or more of randomized participants engage in 1 or more sessions; 75% or more of randomized participants engage in at least 6 of 9 sessions

Intervention Fidelity

Demonstrate the fidelity of the intervention(s) used in the study by: Program facilitators deliver 90% of session activities 90% of the time

Data Collection Feasibility

Demonstrate the ability to collect study data by: 80% or more of randomized participants complete follow up at 2 months (end of the study)

Safety and Tolerability of the Interventions

Demonstrate the safety and tolerability of the intervention(s) used in the study by: 5% or less of randomized participants experience a severe or serious adverse event related to the intervention(s)

Safety and Tolerability of the Interventions

Demonstrate the safety and tolerability of the intervention(s) used in the study by: 75% or more of randomized participants attend at least 6 of 9 sessions;

Safety and Tolerability of the Interventions

Demonstrate the safety and tolerability of the intervention(s) used in the study by: 75% or more of randomized participants are satisfied with assigned program

Secondary Outcome Measures

Full Information

NCT ID

NCT05786508

First Posted

February 15, 2023

Last Updated

October 2, 2023

Sponsor

University of Minnesota

1. Study Identification

Unique Protocol Identification Number

NCT05786508

Brief Title

Partners for Pain & Wellbeing Equity: A Randomized Trial of Community Supported Complementary and Integrative Health Self-management for Back Pain

Official Title

Partners for Pain & Wellbeing Equity: A Randomized Trial of Community Supported Complementary and Integrative Health Self-management for Back Pain

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 28, 2023 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

Brief Summary

The focus of this project is on developing and optimizing community-based programs for the self-management of back or neck pain for individuals from populations that experience health disparities (BP-PEHD). Community-engaged research approach will be used to conduct quality improvement activities that involves gathering feedback from multiple stakeholders to inform development of the study interventions and materials which will be followed by a randomized pilot study to evaluate feasibility. Supported by the National Center for Complementary and Integrative Health through the National Institutes of Health's HEAL initiative (https://heal.nih.gov/)"

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neck Pain, Low Back Pain, Chronic Pain

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Partners4Pain program

Arm Type

Experimental

Arm Description

adults with chronic neck or back pain from populations that experience health disparities due to race/ethnicity or socioeconomic status

Arm Title

Key to Wellbeing program

Arm Type

Active Comparator

Arm Description

adults with chronic neck or back pain from populations that experience health disparities due to race/ethnicity or socioeconomic status

Intervention Type

Other

Intervention Name(s)

Partners4Pain program

Intervention Description

Partners4Pain is a self-management program of evidence based complementary and integrative health approaches for pain including pain education, mindfulness, cognitive behavioral approaches, and neck/back specific exercises. The intervention program will include nine, 90-minute group sessions that occur weekly for 9 weeks

Intervention Type

Other

Intervention Name(s)

Key to Wellbeing program

Intervention Description

Keys to Wellbeing is a general health and wellbeing education program addressing topics such as keeping socially connected, finding meaning and purpose, addressing mental health, and keeping physically fit. The program was designed to control for time, attention, and many other key contextual factors (e.g., program format, materials). The intervention program will include nine, 90-minute group sessions that occur weekly for 9 weeks

Primary Outcome Measure Information:

Title

Participant Recruitment

Description

Demonstrate the ability to recruit and retain subjects in the clinical study as follows: Randomize at least 30 participants

Time Frame

2 months

Title

Participant Recruitment

Description

Demonstrate the ability to recruit and retain subjects in the clinical study as follows: 75% or more of randomized participants are from NIH-defined racial/ethnic health disparity groups;

Time Frame

2 months

Title

Participant Retention Feasibility

Description

Demonstrate the ability to recruit and retain subjects in the clinical study as follows: 80% or more of randomized participants are retained for primary outcome measurement at the end of the study (2 month follow up) regardless of adherence to the intervention

Time Frame

2 months

Title

Intervention Delivery Feasibility

Description

Demonstrate that the delivery of the intervention(s) and the control intervention(s) under study can be delivered consistently, as defined by: 85% or more of randomized participants engage in 1 or more sessions; 75% or more of randomized participants engage in at least 6 of 9 sessions

Time Frame

9 weeks

Title

Intervention Fidelity

Description

Demonstrate the fidelity of the intervention(s) used in the study by: Program facilitators deliver 90% of session activities 90% of the time

Time Frame

9 weeks

Title

Data Collection Feasibility

Description

Demonstrate the ability to collect study data by: 80% or more of randomized participants complete follow up at 2 months (end of the study)

Time Frame

2 months

Title

Safety and Tolerability of the Interventions

Description

Demonstrate the safety and tolerability of the intervention(s) used in the study by: 5% or less of randomized participants experience a severe or serious adverse event related to the intervention(s)

Time Frame

9 weeks

Title

Safety and Tolerability of the Interventions

Description

Demonstrate the safety and tolerability of the intervention(s) used in the study by: 75% or more of randomized participants attend at least 6 of 9 sessions;

Time Frame

9 weeks

Title

Safety and Tolerability of the Interventions

Description

Demonstrate the safety and tolerability of the intervention(s) used in the study by: 75% or more of randomized participants are satisfied with assigned program

Time Frame

9 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Provide a signed and dated informed consent form State willingness to comply with all study procedures outlined in the consent form Be 18 years of age or older Have self-reported chronic back pain (defined as pain in the low or mid back, or neck pain) which has lasted for 3 months or longer Have a score of 3 or higher on the self-reported Pain, Enjoyment of Life and General Activity (PEG) scale (0 to 10) Be a member of one or more of the following NIH-designated health disparity populations: American Indian/Alaska Native, Asian, Black/African American, Hispanic/Latino, Native Hawaiian/Pacific Islanders, Socioeconomically disadvantaged (annual household income less than $50,000) Exclusion Criteria: Hospitalization for severe mental illness in past six months because the mindfulness and behavioral mind-body practices (e.g., meditation, progressive muscle relaxation, etc.) in the experimental intervention may aggravate symptoms of severe mental illness Active psychotic symptoms, suicidal ideation, or manic episodes in the past three months for the same reasons noted in #1 Self-reported cancer with active treatment involving radiation or chemotherapy due to the potential for complications of their back or neck pain and impact on health outcomes Dementia - Mini Mental State Exam score of 23 or lower for those with suspicion of cognitive impairment due to safety risks (e.g., not being able to follow directions for safe physical exercise) Self-reported pregnancy due to the fact that back pain is often associated with pregnancy and differs from non-pregnancy related back pain and thus might have different impacts on health outcomes Children under the age of 18

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roni Evans, PhD, DC,MS

Organizational Affiliation

University of Minnesota

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Brent Leininger, PhD, DC, MS

Organizational Affiliation

University of Minnesota

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Minnesota

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55414

Country

United States

Neck Pain, Low Back Pain, Chronic Pain

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial