NCT05786508

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

Completed NA Results posted Last updated 10 December 2024

What this trial tests

NA trial testing Partners4Pain program in Neck Pain in 51 participants. Completed in 19 December 2023.

Timeline

28 August 2023

Primary endpoint
19 December 2023

19 December 2023

Quick facts

Lead sponsor	University of Minnesota
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	51
Start date	28 August 2023
Primary completion	19 December 2023
Estimated completion	19 December 2023
Sites	1 location across United States

Drugs / interventions tested

• Partners4Pain program
• Key to Wellbeing program

Conditions studied

• Neck Pain — all drugs for Neck Pain →
• Low Back Pain — all drugs for Low Back Pain →
• Chronic Pain — all drugs for Chronic Pain →

Sponsor

University of Minnesota

Who can join

18 and older, any sex, with Neck Pain or Low Back Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Recruitment Feasibility: # of Enrolled Participants Primary · 2 months

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

Group	Value	95% CI
Enrolled Participants	51

Recruitment Feasibility: % of Enrolled Participants From NIH-defined Racial or Ethnic Disparity Groups Primary · 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;

Group	Value	95% CI
Enrolled Participants	40

Participant Retention Feasibility: Primary Outcome Measurement Primary · 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

Group	Value	95% CI
Enrolled Participants	49

Intervention Delivery Feasibility: Participant Engagement Primary · 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

Engage in 1 or more sessions

Group	Value	95% CI
Partners4Pain Program	24
Key to Wellbeing Program	25

Engage in 6 or more sessions

Group	Value	95% CI
Partners4Pain Program	24
Key to Wellbeing Program	24

Intervention Fidelity: Facilitator Delivery of Required Activities Primary · 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

Group	Value	95% CI
Partners4Pain Program	9
Key to Wellbeing Program	9

Data Collection Feasibility: Completion of Self-reported Outcomes Primary · 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)

Group	Value	95% CI
Partners4Pain Program	24
Key to Wellbeing Program	25

Safety and Tolerability of the Interventions: Severe or Serious Related Adverse Events Primary · 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

Group	Value	95% CI
Partners4Pain Program	0
Key to Wellbeing Program	1

Safety and Tolerability of the Interventions: Satisfaction With Program Primary · 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

Group	Value	95% CI
Partners4Pain Program	21
Key to Wellbeing Program	21

Adverse events — posted to ClinicalTrials.gov

Time frame: 9 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Partners4Pain Program

Serious: 0/26 (0%)

Deaths: 0/26

Key to Wellbeing Program

Serious: 2/25 (8%)

Deaths: 0/25

Serious adverse events (2 terms)

Reaction	System	Partners4Pain Program	Key to Wellbeing Program
Hip Fracture	Musculoskeletal and connective tissue disorders	—	—
Motor Vehicle Accident	Injury, poisoning and procedural complications	—	—

Other adverse events (7 terms — click to expand)

Reaction	System	Partners4Pain Program	Key to Wellbeing Program
Feeling more tired or fatigued than usual	General disorders	—	—
Worsening back or neck pain	Musculoskeletal and connective tissue disorders	—	—
Increased muscle soreness	Musculoskeletal and connective tissue disorders	—	—
Increased feelings of anxiousness	Psychiatric disorders	—	—
Feeling more isolated or lonely	Social circumstances	—	—
Increased feelings of sadness	Psychiatric disorders	—	—
Feeling more upset than usual when reminded of the past	Psychiatric disorders	—	—

Most-reported serious reactions: Hip Fracture, Motor Vehicle Accident.

Data from ClinicalTrials.gov NCT05786508 adverse events section.

Sponsor's own description

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/)"

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.