Chronic Pain, Low Back Pain, Neck Pain
Conditions
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/)
Interventions
OTHERPartners4Pain 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 will include nine, 90-minute group sessions that occur weekly for 9 weeks
OTHERKey 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 will include nine, 90-minute group sessions that occur weekly for 9 weeks
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
National Institute of Neurological Disorders and Stroke (NINDS)
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Feasibility: # of Enrolled Participants | 2 months | Demonstrate the ability to recruit and retain subjects in the clinical study as follows: Randomize at least 30 participants |
| Recruitment Feasibility: % of Enrolled Participants From NIH-defined Racial or Ethnic Disparity Groups | 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; |
| Participant Retention Feasibility: Primary Outcome Measurement | 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 |
| Intervention Delivery Feasibility: Participant Engagement | 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 |
| Intervention Fidelity: Facilitator Delivery of Required Activities | 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 |
| Data Collection Feasibility: Completion of Self-reported Outcomes | 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) |
| Safety and Tolerability of the Interventions: Severe or Serious Related Adverse Events | 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 |
| Safety and Tolerability of the Interventions: Satisfaction With Program | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 26 |
| 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 | 25 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Total | Partners4Pain Program | Key to Wellbeing Program |
|---|---|---|---|
| Age, Continuous | 56 years STANDARD_DEVIATION 14.6 | 55 years STANDARD_DEVIATION 13.5 | 57 years STANDARD_DEVIATION 15.9 |
| Pain, Enjoyment of Life and General Activity (PEG) | 6.5 units on a scale STANDARD_DEVIATION 2 | 6.7 units on a scale STANDARD_DEVIATION 2.2 | 6.4 units on a scale STANDARD_DEVIATION 1.7 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Another Hispanic, Latino, or Spanish origin (e.g. Savadorian, Dominican, Columbian, Guatemalan, etc) | 4 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian Indian | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American (African American, Jamaican, Haitian, Nigerian, Ethiopian, Somali, etc.) | 29 Participants | 16 Participants | 13 Participants |
| Race/Ethnicity, Customized Chinese | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Mexican, Mexican American, Chicano | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized More Than One Race | 3 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized No Hispanic, Latino, or Spanish origin | 45 Participants | 23 Participants | 22 Participants |
| Race/Ethnicity, Customized Other Asian (Pakistani, Cambodian, Hmong, etc.) | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other Race (Mestizo) | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other Race (Mexican) | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White (German, Irish, English, Italian, Lebanese, Egyptian, etc.) | 12 Participants | 5 Participants | 7 Participants |
| Region of Enrollment United States | 51 participants | 26 participants | 25 participants |
| Sex: Female, Male Female | 42 Participants | 20 Participants | 22 Participants |
| Sex: Female, Male Male | 9 Participants | 6 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 25 |
| other Total, other adverse events | 8 / 26 | 14 / 25 |
| serious Total, serious adverse events | 0 / 26 | 2 / 25 |
Outcome results
Primary
Data Collection Feasibility: Completion of Self-reported Outcomes
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enrolled Participants | Data Collection Feasibility: Completion of Self-reported Outcomes | 24 Participants |
| Key to Wellbeing Program | Data Collection Feasibility: Completion of Self-reported Outcomes | 25 Participants |
Primary
Intervention Delivery Feasibility: Participant Engagement
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enrolled Participants | Intervention Delivery Feasibility: Participant Engagement | Engage in 1 or more sessions | 24 Participants |
| Enrolled Participants | Intervention Delivery Feasibility: Participant Engagement | Engage in 6 or more sessions | 24 Participants |
| Key to Wellbeing Program | Intervention Delivery Feasibility: Participant Engagement | Engage in 1 or more sessions | 25 Participants |
| Key to Wellbeing Program | Intervention Delivery Feasibility: Participant Engagement | Engage in 6 or more sessions | 24 Participants |
Primary
Intervention Fidelity: Facilitator Delivery of Required Activities
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
Time frame: 9 weeks
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Enrolled Participants | Intervention Fidelity: Facilitator Delivery of Required Activities | 9 Sessions |
| Key to Wellbeing Program | Intervention Fidelity: Facilitator Delivery of Required Activities | 9 Sessions |
Primary
Participant Retention Feasibility: Primary Outcome Measurement
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enrolled Participants | Participant Retention Feasibility: Primary Outcome Measurement | 49 Participants |
Primary
Recruitment Feasibility: # of Enrolled Participants
Demonstrate the ability to recruit and retain subjects in the clinical study as follows: Randomize at least 30 participants
Time frame: 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enrolled Participants | Recruitment Feasibility: # of Enrolled Participants | 51 Participants |
Primary
Recruitment Feasibility: % of Enrolled Participants From NIH-defined Racial or Ethnic Disparity Groups
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enrolled Participants | Recruitment Feasibility: % of Enrolled Participants From NIH-defined Racial or Ethnic Disparity Groups | 40 Participants |
Primary
Safety and Tolerability of the Interventions: Satisfaction With Program
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enrolled Participants | Safety and Tolerability of the Interventions: Satisfaction With Program | 21 Participants |
| Key to Wellbeing Program | Safety and Tolerability of the Interventions: Satisfaction With Program | 21 Participants |
Primary
Safety and Tolerability of the Interventions: Severe or Serious Related Adverse Events
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
Time frame: 9 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enrolled Participants | Safety and Tolerability of the Interventions: Severe or Serious Related Adverse Events | 0 Participants |
| Key to Wellbeing Program | Safety and Tolerability of the Interventions: Severe or Serious Related Adverse Events | 1 Participants |