Trial Outcomes & Findings for Partners for Pain & Wellbeing Equity: A Randomized Trial of Community Supported Complementary and Integrative Health Self-management for Back Pain (NCT NCT05786508)

NCT ID: NCT05786508

Last Updated: 2024-12-10

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 51 participants
• Primary outcome timeframe: 2 months
• Results posted on: 2024-12-10

Participant Flow

Participant milestones

Measure	Partners4Pain Program 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 included nine, 90-minute group sessions that occurred weekly for 9 weeks	Key to Wellbeing Program 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 included nine, 90-minute group sessions that occurred weekly for 9 weeks
Overall Study STARTED	26	25
Overall Study COMPLETED	24	25
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Partners4Pain Program 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 included nine, 90-minute group sessions that occurred weekly for 9 weeks	Key to Wellbeing Program 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 included nine, 90-minute group sessions that occurred weekly for 9 weeks
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Partners4Pain Program n=26 Participants 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 included nine, 90-minute group sessions that occurred weekly for 9 weeks	Key to Wellbeing Program n=25 Participants 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 included nine, 90-minute group sessions that occurred weekly for 9 weeks	Total n=51 Participants Total of all reporting groups
Age, Continuous	55 years STANDARD_DEVIATION 13.5 • n=5 Participants	57 years STANDARD_DEVIATION 15.9 • n=7 Participants	56 years STANDARD_DEVIATION 14.6 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized No Hispanic, Latino, or Spanish origin	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Race/Ethnicity, Customized Mexican, Mexican American, Chicano	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Another Hispanic, Latino, or Spanish origin (e.g. Savadorian, Dominican, Columbian, Guatemalan, etc)	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American (African American, Jamaican, Haitian, Nigerian, Ethiopian, Somali, etc.)	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
Race/Ethnicity, Customized White (German, Irish, English, Italian, Lebanese, Egyptian, etc.)	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Chinese	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian Indian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other Asian (Pakistani, Cambodian, Hmong, etc.)	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other Race (Mestizo)	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other Race (Mexican)	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized More Than One Race	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants	25 participants n=7 Participants	51 participants n=5 Participants
Pain, Enjoyment of Life and General Activity (PEG)	6.7 units on a scale STANDARD_DEVIATION 2.2 • n=5 Participants	6.4 units on a scale STANDARD_DEVIATION 1.7 • n=7 Participants	6.5 units on a scale STANDARD_DEVIATION 2.0 • n=5 Participants

PRIMARY outcome

Timeframe: 2 months

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

Outcome measures

Measure	Enrolled Participants n=51 Participants Individuals enrolled into the randomized trial	Key to Wellbeing Program 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 included nine, 90-minute group sessions that occurred weekly for 9 weeks
Recruitment Feasibility: # of Enrolled Participants	51 Participants	—

PRIMARY outcome

Timeframe: 2 months

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;

Outcome measures

Measure	Enrolled Participants n=51 Participants Individuals enrolled into the randomized trial	Key to Wellbeing Program 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 included nine, 90-minute group sessions that occurred weekly for 9 weeks
Recruitment Feasibility: % of Enrolled Participants From NIH-defined Racial or Ethnic Disparity Groups	40 Participants	—

PRIMARY outcome

Timeframe: 2 months

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

Outcome measures

Measure	Enrolled Participants n=51 Participants Individuals enrolled into the randomized trial	Key to Wellbeing Program 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 included nine, 90-minute group sessions that occurred weekly for 9 weeks
Participant Retention Feasibility: Primary Outcome Measurement	49 Participants	—

PRIMARY outcome

Timeframe: 9 weeks

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

Outcome measures

Measure	Enrolled Participants n=26 Participants Individuals enrolled into the randomized trial	Key to Wellbeing Program n=25 Participants 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 included nine, 90-minute group sessions that occurred weekly for 9 weeks
Intervention Delivery Feasibility: Participant Engagement Engage in 1 or more sessions	24 Participants	25 Participants
Intervention Delivery Feasibility: Participant Engagement Engage in 6 or more sessions	24 Participants	24 Participants

PRIMARY outcome

Timeframe: 9 weeks

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

Outcome measures

Measure	Enrolled Participants n=9 Sessions Individuals enrolled into the randomized trial	Key to Wellbeing Program n=9 Sessions 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 included nine, 90-minute group sessions that occurred weekly for 9 weeks
Intervention Fidelity: Facilitator Delivery of Required Activities	9 Sessions	9 Sessions

PRIMARY outcome

Timeframe: 2 months

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

Outcome measures

Measure	Enrolled Participants n=26 Participants Individuals enrolled into the randomized trial	Key to Wellbeing Program n=25 Participants 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 included nine, 90-minute group sessions that occurred weekly for 9 weeks
Data Collection Feasibility: Completion of Self-reported Outcomes	24 Participants	25 Participants

PRIMARY outcome

Timeframe: 9 weeks

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 interventions

Outcome measures

Measure	Enrolled Participants n=26 Participants Individuals enrolled into the randomized trial	Key to Wellbeing Program n=25 Participants 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 included nine, 90-minute group sessions that occurred weekly for 9 weeks
Safety and Tolerability of the Interventions: Severe or Serious Related Adverse Events	0 Participants	1 Participants

PRIMARY outcome

Timeframe: 9 weeks

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

Outcome measures

Measure	Enrolled Participants n=26 Participants Individuals enrolled into the randomized trial	Key to Wellbeing Program n=25 Participants 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 included nine, 90-minute group sessions that occurred weekly for 9 weeks
Safety and Tolerability of the Interventions: Satisfaction With Program	21 Participants	21 Participants

Adverse Events

Partners4Pain Program

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Key to Wellbeing Program

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Partners4Pain Program n=26 participants at risk 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 included nine, 90-minute group sessions that occurred weekly for 9 weeks	Key to Wellbeing Program n=25 participants at risk 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 included nine, 90-minute group sessions that occurred weekly for 9 weeks
Musculoskeletal and connective tissue disorders Hip Fracture	0.00% 0/26 • 9 weeks	4.0% 1/25 • Number of events 1 • 9 weeks
Injury, poisoning and procedural complications Motor Vehicle Accident	0.00% 0/26 • 9 weeks	4.0% 1/25 • Number of events 1 • 9 weeks

Other adverse events

Measure	Partners4Pain Program n=26 participants at risk 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 included nine, 90-minute group sessions that occurred weekly for 9 weeks	Key to Wellbeing Program n=25 participants at risk 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 included nine, 90-minute group sessions that occurred weekly for 9 weeks
Musculoskeletal and connective tissue disorders Worsening back or neck pain	15.4% 4/26 • Number of events 4 • 9 weeks	24.0% 6/25 • Number of events 6 • 9 weeks
Musculoskeletal and connective tissue disorders Increased muscle soreness	23.1% 6/26 • Number of events 6 • 9 weeks	20.0% 5/25 • Number of events 5 • 9 weeks
Psychiatric disorders Feeling more upset than usual when reminded of the past	7.7% 2/26 • Number of events 2 • 9 weeks	8.0% 2/25 • Number of events 2 • 9 weeks
Psychiatric disorders Increased feelings of sadness	11.5% 3/26 • Number of events 3 • 9 weeks	8.0% 2/25 • Number of events 2 • 9 weeks
Psychiatric disorders Increased feelings of anxiousness	7.7% 2/26 • Number of events 2 • 9 weeks	16.0% 4/25 • Number of events 4 • 9 weeks
General disorders Feeling more tired or fatigued than usual	11.5% 3/26 • Number of events 3 • 9 weeks	32.0% 8/25 • Number of events 8 • 9 weeks
Social circumstances Feeling more isolated or lonely	7.7% 2/26 • Number of events 2 • 9 weeks	16.0% 4/25 • Number of events 4 • 9 weeks

Additional Information

Brent Leininger

University of Minnesota

Phone: 6126266477

Email: lein0122@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place