Trial Outcomes & Findings for Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain (NCT NCT05022121)

NCT ID: NCT05022121

Last Updated: 2024-03-15

Results Overview

As a measure of recruitment feasibility, the average number of participants screened per month is reported

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 42 participants
• Primary outcome timeframe: 6 month period of active study screening
• Results posted on: 2024-03-15

Participant Flow

Participant milestones

Measure	Supported Biopsychosocial Self-Management (SBSM) Supported Biopsychosocial Self-Management (SBSM) Supported Biopsychosocial Self-Management (SBSM): Participants receive training and instruction in skills to engage in healthy physical, psychological, and social self-management behaviors. This will be accomplished through 6-12 sessions with a trained chiropractor or physical therapist. Patients will receive training and instruction in exercises targeting posture, strength, stabilization, and mobility based on their individual needs. They will learn psychological strategies including problem solving and cognitive restructuring to address unhelpful thoughts and emotions. Social strategies include pleasant activity planning with a social focus, and communication techniques for navigating relationships to garner support for self-sufficiency. Other elements include providing key evidence based information about BRLP and spinal manipulation therapies (SMT). SMT will include manipulation, mobilization and soft-tissue treatment. Other intervention elements include enablement, persuasion, and resources and materials to support the patient.	Medical Care Medical Care Medical Care: Medical care will be comprised of primarily medication management, which is a standard first-line approach for back-related leg pain in primary care. Choice of medications is informed by the current evidence and the American College of Physicians guidelines on noninvasive treatment for LBP which balances evidence for risks and benefits when making recommendations. Decisions regarding medication selection will be made collaboratively between the study provider and patient after a discussion of risk/benefit profiles and patient preferences, including prior response. Study providers licensed to prescribe FDA-approved medications will call-in the prescription for the medication of choice to the participant's preferred pharmacy, as is typical in clinical practice.
Overall Study STARTED	20	22
Overall Study COMPLETED	19	20
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Measure	Supported Biopsychosocial Self-Management (SBSM) Supported Biopsychosocial Self-Management (SBSM) Supported Biopsychosocial Self-Management (SBSM): Participants receive training and instruction in skills to engage in healthy physical, psychological, and social self-management behaviors. This will be accomplished through 6-12 sessions with a trained chiropractor or physical therapist. Patients will receive training and instruction in exercises targeting posture, strength, stabilization, and mobility based on their individual needs. They will learn psychological strategies including problem solving and cognitive restructuring to address unhelpful thoughts and emotions. Social strategies include pleasant activity planning with a social focus, and communication techniques for navigating relationships to garner support for self-sufficiency. Other elements include providing key evidence based information about BRLP and spinal manipulation therapies (SMT). SMT will include manipulation, mobilization and soft-tissue treatment. Other intervention elements include enablement, persuasion, and resources and materials to support the patient.	Medical Care Medical Care Medical Care: Medical care will be comprised of primarily medication management, which is a standard first-line approach for back-related leg pain in primary care. Choice of medications is informed by the current evidence and the American College of Physicians guidelines on noninvasive treatment for LBP which balances evidence for risks and benefits when making recommendations. Decisions regarding medication selection will be made collaboratively between the study provider and patient after a discussion of risk/benefit profiles and patient preferences, including prior response. Study providers licensed to prescribe FDA-approved medications will call-in the prescription for the medication of choice to the participant's preferred pharmacy, as is typical in clinical practice.
Overall Study Lack of Efficacy	1	0
Overall Study Lost to Follow-up	0	2

Baseline Characteristics

Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain

Baseline characteristics by cohort

Measure	Supported Biopsychosocial Self-Management (SBSM) n=20 Participants Supported Biopsychosocial Self-Management (SBSM) Supported Biopsychosocial Self-Management (SBSM): Participants receive training and instruction in skills to engage in healthy physical, psychological, and social self-management behaviors. This will be accomplished through 6-12 sessions with a trained chiropractor or physical therapist. Patients will receive training and instruction in exercises targeting posture, strength, stabilization, and mobility based on their individual needs. They will learn psychological strategies including problem solving and cognitive restructuring to address unhelpful thoughts and emotions. Social strategies include pleasant activity planning with a social focus, and communication techniques for navigating relationships to garner support for self-sufficiency. Other elements include providing key evidence based information about BRLP and spinal manipulation therapies (SMT). SMT will include manipulation, mobilization and soft-tissue treatment. Other intervention elements include enablement, persuasion, and resources and materials to support the patient.	Medical Care n=22 Participants Medical Care Medical Care: Medical care will be comprised of primarily medication management, which is a standard first-line approach for back-related leg pain in primary care. Choice of medications is informed by the current evidence and the American College of Physicians guidelines on noninvasive treatment for LBP which balances evidence for risks and benefits when making recommendations. Decisions regarding medication selection will be made collaboratively between the study provider and patient after a discussion of risk/benefit profiles and patient preferences, including prior response. Study providers licensed to prescribe FDA-approved medications will call-in the prescription for the medication of choice to the participant's preferred pharmacy, as is typical in clinical practice.	Total n=42 Participants Total of all reporting groups
Age, Continuous	54.3 years STANDARD_DEVIATION 14.6 • n=5 Participants	51.6 years STANDARD_DEVIATION 14.0 • n=7 Participants	52.9 years STANDARD_DEVIATION 14.2 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	14 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	15 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 month period of active study screening

As a measure of recruitment feasibility, the average number of participants screened per month is reported

Outcome measures

Measure	Screened Participants n=617 Participants Individuals contacting study staff expressing interest in participating	Medical Care Medical Care Medical Care: Medical care will be comprised of primarily medication management, which is a standard first-line approach for back-related leg pain in primary care. Choice of medications is informed by the current evidence and the American College of Physicians guidelines on noninvasive treatment for LBP which balances evidence for risks and benefits when making recommendations. Decisions regarding medication selection will be made collaboratively between the study provider and patient after a discussion of risk/benefit profiles and patient preferences, including prior response. Study providers licensed to prescribe FDA-approved medications will call-in the prescription for the medication of choice to the participant's preferred pharmacy, as is typical in clinical practice.
Number of Particpants Screened Per Month	103 participants per month Interval 26.0 to 247.0	—

PRIMARY outcome

Timeframe: 6 month period of active study screening

As a measure of recruitment feasibility, the number of female participants in the study is reported

Outcome measures

Measure	Screened Participants n=617 Participants Individuals contacting study staff expressing interest in participating	Medical Care Medical Care Medical Care: Medical care will be comprised of primarily medication management, which is a standard first-line approach for back-related leg pain in primary care. Choice of medications is informed by the current evidence and the American College of Physicians guidelines on noninvasive treatment for LBP which balances evidence for risks and benefits when making recommendations. Decisions regarding medication selection will be made collaboratively between the study provider and patient after a discussion of risk/benefit profiles and patient preferences, including prior response. Study providers licensed to prescribe FDA-approved medications will call-in the prescription for the medication of choice to the participant's preferred pharmacy, as is typical in clinical practice.
Percentage of Screened Participants Who Are Female	414 Participants	—

PRIMARY outcome

Timeframe: 6 month period of active study screening

As a measure of recruitment feasibility, the number of participants from racial or ethnic minority populations is reported.

Outcome measures

Measure	Screened Participants n=617 Participants Individuals contacting study staff expressing interest in participating	Medical Care Medical Care Medical Care: Medical care will be comprised of primarily medication management, which is a standard first-line approach for back-related leg pain in primary care. Choice of medications is informed by the current evidence and the American College of Physicians guidelines on noninvasive treatment for LBP which balances evidence for risks and benefits when making recommendations. Decisions regarding medication selection will be made collaboratively between the study provider and patient after a discussion of risk/benefit profiles and patient preferences, including prior response. Study providers licensed to prescribe FDA-approved medications will call-in the prescription for the medication of choice to the participant's preferred pharmacy, as is typical in clinical practice.
Percentage of Screened Participants Who Are From Racial or Ethnic Minority Populations	168 Participants	—

PRIMARY outcome

Timeframe: 6 month period of active study screening

As a measure of enrollment feasibility, the average number of participants recruited per month is reported.

Outcome measures

Measure	Screened Participants n=42 Participants Individuals contacting study staff expressing interest in participating	Medical Care Medical Care Medical Care: Medical care will be comprised of primarily medication management, which is a standard first-line approach for back-related leg pain in primary care. Choice of medications is informed by the current evidence and the American College of Physicians guidelines on noninvasive treatment for LBP which balances evidence for risks and benefits when making recommendations. Decisions regarding medication selection will be made collaboratively between the study provider and patient after a discussion of risk/benefit profiles and patient preferences, including prior response. Study providers licensed to prescribe FDA-approved medications will call-in the prescription for the medication of choice to the participant's preferred pharmacy, as is typical in clinical practice.
Number of Participants Enrolled Per Month	7 participants per month Interval 3.0 to 11.0	—

PRIMARY outcome

Timeframe: 6 month period of active study enrollment

As a measure of enrollment feasibility, the number of female participants enrolled in the study is reported.

Outcome measures

Measure	Screened Participants n=42 Participants Individuals contacting study staff expressing interest in participating	Medical Care Medical Care Medical Care: Medical care will be comprised of primarily medication management, which is a standard first-line approach for back-related leg pain in primary care. Choice of medications is informed by the current evidence and the American College of Physicians guidelines on noninvasive treatment for LBP which balances evidence for risks and benefits when making recommendations. Decisions regarding medication selection will be made collaboratively between the study provider and patient after a discussion of risk/benefit profiles and patient preferences, including prior response. Study providers licensed to prescribe FDA-approved medications will call-in the prescription for the medication of choice to the participant's preferred pharmacy, as is typical in clinical practice.
Percentage of Enrolled Participants Who Are Female	25 Participants	—

PRIMARY outcome

Timeframe: 6 month period of active enrollment

As a measure of enrollment feasibility, the number of participants enrolled from racial or ethnic minority populations is reported.

Outcome measures

Measure	Screened Participants n=42 Participants Individuals contacting study staff expressing interest in participating	Medical Care Medical Care Medical Care: Medical care will be comprised of primarily medication management, which is a standard first-line approach for back-related leg pain in primary care. Choice of medications is informed by the current evidence and the American College of Physicians guidelines on noninvasive treatment for LBP which balances evidence for risks and benefits when making recommendations. Decisions regarding medication selection will be made collaboratively between the study provider and patient after a discussion of risk/benefit profiles and patient preferences, including prior response. Study providers licensed to prescribe FDA-approved medications will call-in the prescription for the medication of choice to the participant's preferred pharmacy, as is typical in clinical practice.
Percentage of Enrolled Participants Who Are From Racial or Ethnic Minority Populations	8 Participants	—

PRIMARY outcome

Timeframe: Through study treatment, an average of 3 months

As a measure of intervention acceptability and credibility associated with feasibility, the number of enrollees not receiving any treatment is reported.

Outcome measures

Measure	Screened Participants n=20 Participants Individuals contacting study staff expressing interest in participating	Medical Care n=22 Participants Medical Care Medical Care: Medical care will be comprised of primarily medication management, which is a standard first-line approach for back-related leg pain in primary care. Choice of medications is informed by the current evidence and the American College of Physicians guidelines on noninvasive treatment for LBP which balances evidence for risks and benefits when making recommendations. Decisions regarding medication selection will be made collaboratively between the study provider and patient after a discussion of risk/benefit profiles and patient preferences, including prior response. Study providers licensed to prescribe FDA-approved medications will call-in the prescription for the medication of choice to the participant's preferred pharmacy, as is typical in clinical practice.
Percentage of Enrollees Not Receiving Any Treatment	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Through study treatment, an average of 3 months

As a measure of intervention acceptability and credibility associated with feasibility, the number of enrollees receiving prohibited treatments, (contamination), during the 12-week intervention phase of the study is reported.

Outcome measures

Measure	Screened Participants n=20 Participants Individuals contacting study staff expressing interest in participating	Medical Care n=22 Participants Medical Care Medical Care: Medical care will be comprised of primarily medication management, which is a standard first-line approach for back-related leg pain in primary care. Choice of medications is informed by the current evidence and the American College of Physicians guidelines on noninvasive treatment for LBP which balances evidence for risks and benefits when making recommendations. Decisions regarding medication selection will be made collaboratively between the study provider and patient after a discussion of risk/benefit profiles and patient preferences, including prior response. Study providers licensed to prescribe FDA-approved medications will call-in the prescription for the medication of choice to the participant's preferred pharmacy, as is typical in clinical practice.
Percentage of Enrollees Receiving Prohibited Treatments	1 Participants	1 Participants

PRIMARY outcome

Timeframe: Through study treatment, an average of 3 months

As a measure of intervention acceptability and credibility associated with feasibility, treatment satisfaction was reported by participants via a 7-point Likert satisfaction scale, ranging from 1, "completely satisfied," to 7, "completely dissatisfied," where lower numbers indicate greater satisfaction. The percentage of enrollees satisfied with treatment is reported as a percent value representing those who choose "somewhat satisfied" or better on the scale.

Outcome measures

Measure	Screened Participants n=20 Participants Individuals contacting study staff expressing interest in participating	Medical Care n=22 Participants Medical Care Medical Care: Medical care will be comprised of primarily medication management, which is a standard first-line approach for back-related leg pain in primary care. Choice of medications is informed by the current evidence and the American College of Physicians guidelines on noninvasive treatment for LBP which balances evidence for risks and benefits when making recommendations. Decisions regarding medication selection will be made collaboratively between the study provider and patient after a discussion of risk/benefit profiles and patient preferences, including prior response. Study providers licensed to prescribe FDA-approved medications will call-in the prescription for the medication of choice to the participant's preferred pharmacy, as is typical in clinical practice.
Percentage of Enrollees Satisfied With Treatment	17 Participants	14 Participants

PRIMARY outcome

Timeframe: Through study treatment, an average of 3 months

As a measure of participant treatment adherence associated with feasibility, the number of enrollees attending the minimum number of required study sessions (6 for SBSM and 2 for Medical Care) are reported.

Outcome measures

Measure	Screened Participants n=20 Participants Individuals contacting study staff expressing interest in participating	Medical Care n=22 Participants Medical Care Medical Care: Medical care will be comprised of primarily medication management, which is a standard first-line approach for back-related leg pain in primary care. Choice of medications is informed by the current evidence and the American College of Physicians guidelines on noninvasive treatment for LBP which balances evidence for risks and benefits when making recommendations. Decisions regarding medication selection will be made collaboratively between the study provider and patient after a discussion of risk/benefit profiles and patient preferences, including prior response. Study providers licensed to prescribe FDA-approved medications will call-in the prescription for the medication of choice to the participant's preferred pharmacy, as is typical in clinical practice.
Percentage of Enrollees Attending Required Sessions	19 Participants	20 Participants

PRIMARY outcome

Timeframe: Through study treatment, an average of 3 months

As a measure of participant treatment adherence associated with feasibility, the number of enrollees who are part of the supported biopsychosocial self-management arm of the study who self-report participation in home treatment practice is reported.

Outcome measures

Measure	Screened Participants n=20 Participants Individuals contacting study staff expressing interest in participating	Medical Care Medical Care Medical Care: Medical care will be comprised of primarily medication management, which is a standard first-line approach for back-related leg pain in primary care. Choice of medications is informed by the current evidence and the American College of Physicians guidelines on noninvasive treatment for LBP which balances evidence for risks and benefits when making recommendations. Decisions regarding medication selection will be made collaboratively between the study provider and patient after a discussion of risk/benefit profiles and patient preferences, including prior response. Study providers licensed to prescribe FDA-approved medications will call-in the prescription for the medication of choice to the participant's preferred pharmacy, as is typical in clinical practice.
Percentage of Enrollees in Supported Biopsychosocial Self-management Group Reporting Participation in Home Practice	19 Participants	—

PRIMARY outcome

Timeframe: Through study treatment, an average of 3 months

As a measure of participant treatment adherence associated with feasibility, the number of enrollees who are part of the medical care arm self-reporting taking medications as prescribed is reported.

Outcome measures

Measure	Screened Participants n=22 Participants Individuals contacting study staff expressing interest in participating	Medical Care Medical Care Medical Care: Medical care will be comprised of primarily medication management, which is a standard first-line approach for back-related leg pain in primary care. Choice of medications is informed by the current evidence and the American College of Physicians guidelines on noninvasive treatment for LBP which balances evidence for risks and benefits when making recommendations. Decisions regarding medication selection will be made collaboratively between the study provider and patient after a discussion of risk/benefit profiles and patient preferences, including prior response. Study providers licensed to prescribe FDA-approved medications will call-in the prescription for the medication of choice to the participant's preferred pharmacy, as is typical in clinical practice.
Percentage of Enrollees in Medical Care Group Reporting Taking Medications as Prescribed	17 Participants	—

PRIMARY outcome

Timeframe: Through study treatment, an average of 3 months

As a measure of provider fidelity, the percentage of provider vists where 100% of required intervention activities were delivered is reported.

Outcome measures

Measure	Screened Participants n=155 Visits Individuals contacting study staff expressing interest in participating	Medical Care n=80 Visits Medical Care Medical Care: Medical care will be comprised of primarily medication management, which is a standard first-line approach for back-related leg pain in primary care. Choice of medications is informed by the current evidence and the American College of Physicians guidelines on noninvasive treatment for LBP which balances evidence for risks and benefits when making recommendations. Decisions regarding medication selection will be made collaboratively between the study provider and patient after a discussion of risk/benefit profiles and patient preferences, including prior response. Study providers licensed to prescribe FDA-approved medications will call-in the prescription for the medication of choice to the participant's preferred pharmacy, as is typical in clinical practice.
Percentage of Provider Visits Where All Required Intervention Activities Were Delivered	111 Visits	79 Visits

PRIMARY outcome

Timeframe: Month 3 assessment

As a measure of data collection feasibility, the number of enrollees completing the month 3 assessment is reported.

Outcome measures

Measure	Screened Participants n=20 Participants Individuals contacting study staff expressing interest in participating	Medical Care n=22 Participants Medical Care Medical Care: Medical care will be comprised of primarily medication management, which is a standard first-line approach for back-related leg pain in primary care. Choice of medications is informed by the current evidence and the American College of Physicians guidelines on noninvasive treatment for LBP which balances evidence for risks and benefits when making recommendations. Decisions regarding medication selection will be made collaboratively between the study provider and patient after a discussion of risk/benefit profiles and patient preferences, including prior response. Study providers licensed to prescribe FDA-approved medications will call-in the prescription for the medication of choice to the participant's preferred pharmacy, as is typical in clinical practice.
Percentage of Enrollees Completing the Month 3 Assessment	18 Participants	20 Participants

PRIMARY outcome

Timeframe: Month 6 assessment

As a measure of data collection feasibility, the number of enrollees completing the month 6 assessment is reported.

Outcome measures

Measure	Screened Participants n=20 Participants Individuals contacting study staff expressing interest in participating	Medical Care n=22 Participants Medical Care Medical Care: Medical care will be comprised of primarily medication management, which is a standard first-line approach for back-related leg pain in primary care. Choice of medications is informed by the current evidence and the American College of Physicians guidelines on noninvasive treatment for LBP which balances evidence for risks and benefits when making recommendations. Decisions regarding medication selection will be made collaboratively between the study provider and patient after a discussion of risk/benefit profiles and patient preferences, including prior response. Study providers licensed to prescribe FDA-approved medications will call-in the prescription for the medication of choice to the participant's preferred pharmacy, as is typical in clinical practice.
Percentage of Enrollees Completing the Month 6 Assessment	18 Participants	20 Participants

PRIMARY outcome

Timeframe: Through completion of all weekly assessments, an average of 6 months

As a measure of data collection feasibility, the number of weekly pain severity and frequency assessments completed by participants is reported.

Outcome measures

Measure	Screened Participants n=520 Weekly Surveys Individuals contacting study staff expressing interest in participating	Medical Care n=572 Weekly Surveys Medical Care Medical Care: Medical care will be comprised of primarily medication management, which is a standard first-line approach for back-related leg pain in primary care. Choice of medications is informed by the current evidence and the American College of Physicians guidelines on noninvasive treatment for LBP which balances evidence for risks and benefits when making recommendations. Decisions regarding medication selection will be made collaboratively between the study provider and patient after a discussion of risk/benefit profiles and patient preferences, including prior response. Study providers licensed to prescribe FDA-approved medications will call-in the prescription for the medication of choice to the participant's preferred pharmacy, as is typical in clinical practice.
Percentage of Weekly Pain Severity and Frequency Assessments Completed	461 Weekly Surveys	479 Weekly Surveys

Adverse Events

Supported Biopsychosocial Self-Management (SBSM)

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Medical Care

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Supported Biopsychosocial Self-Management (SBSM) n=20 participants at risk Supported Biopsychosocial Self-Management (SBSM) Supported Biopsychosocial Self-Management (SBSM): Participants receive training and instruction in skills to engage in healthy physical, psychological, and social self-management behaviors. This will be accomplished through 6-12 sessions with a trained chiropractor or physical therapist. Patients will receive training and instruction in exercises targeting posture, strength, stabilization, and mobility based on their individual needs. They will learn psychological strategies including problem solving and cognitive restructuring to address unhelpful thoughts and emotions. Social strategies include pleasant activity planning with a social focus, and communication techniques for navigating relationships to garner support for self-sufficiency. Other elements include providing key evidence based information about BRLP and spinal manipulation therapies (SMT). SMT will include manipulation, mobilization and soft-tissue treatment. Other intervention elements include enablement, persuasion, and resources and materials to support the patient.	Medical Care n=22 participants at risk Medical Care Medical Care: Medical care will be comprised of primarily medication management, which is a standard first-line approach for back-related leg pain in primary care. Choice of medications is informed by the current evidence and the American College of Physicians guidelines on noninvasive treatment for LBP which balances evidence for risks and benefits when making recommendations. Decisions regarding medication selection will be made collaboratively between the study provider and patient after a discussion of risk/benefit profiles and patient preferences, including prior response. Study providers licensed to prescribe FDA-approved medications will call-in the prescription for the medication of choice to the participant's preferred pharmacy, as is typical in clinical practice.
Musculoskeletal and connective tissue disorders Fracture injury after fall	0.00% 0/20 • 6 months	9.1% 2/22 • Number of events 2 • 6 months

Other adverse events

Measure	Supported Biopsychosocial Self-Management (SBSM) n=20 participants at risk Supported Biopsychosocial Self-Management (SBSM) Supported Biopsychosocial Self-Management (SBSM): Participants receive training and instruction in skills to engage in healthy physical, psychological, and social self-management behaviors. This will be accomplished through 6-12 sessions with a trained chiropractor or physical therapist. Patients will receive training and instruction in exercises targeting posture, strength, stabilization, and mobility based on their individual needs. They will learn psychological strategies including problem solving and cognitive restructuring to address unhelpful thoughts and emotions. Social strategies include pleasant activity planning with a social focus, and communication techniques for navigating relationships to garner support for self-sufficiency. Other elements include providing key evidence based information about BRLP and spinal manipulation therapies (SMT). SMT will include manipulation, mobilization and soft-tissue treatment. Other intervention elements include enablement, persuasion, and resources and materials to support the patient.	Medical Care n=22 participants at risk Medical Care Medical Care: Medical care will be comprised of primarily medication management, which is a standard first-line approach for back-related leg pain in primary care. Choice of medications is informed by the current evidence and the American College of Physicians guidelines on noninvasive treatment for LBP which balances evidence for risks and benefits when making recommendations. Decisions regarding medication selection will be made collaboratively between the study provider and patient after a discussion of risk/benefit profiles and patient preferences, including prior response. Study providers licensed to prescribe FDA-approved medications will call-in the prescription for the medication of choice to the participant's preferred pharmacy, as is typical in clinical practice.
Musculoskeletal and connective tissue disorders Back problems - soreness/stiffness	35.0% 7/20 • Number of events 10 • 6 months	22.7% 5/22 • Number of events 8 • 6 months
Musculoskeletal and connective tissue disorders Back problems - new back or leg pain	10.0% 2/20 • Number of events 2 • 6 months	27.3% 6/22 • Number of events 8 • 6 months
Musculoskeletal and connective tissue disorders Back problems - increased back or leg pain	25.0% 5/20 • Number of events 6 • 6 months	36.4% 8/22 • Number of events 11 • 6 months
Musculoskeletal and connective tissue disorders Back problems - numbness or tingling	10.0% 2/20 • Number of events 2 • 6 months	13.6% 3/22 • Number of events 3 • 6 months
Gastrointestinal disorders Gastrointestinal problems - dry mouth	5.0% 1/20 • Number of events 1 • 6 months	13.6% 3/22 • Number of events 3 • 6 months
Gastrointestinal disorders Gastrointestinal problems - indigestion	0.00% 0/20 • 6 months	9.1% 2/22 • Number of events 2 • 6 months
Gastrointestinal disorders Gastrointestinal problems - abdominal pain	10.0% 2/20 • Number of events 2 • 6 months	18.2% 4/22 • Number of events 4 • 6 months
Gastrointestinal disorders Gastrointestinal problems - reflux	0.00% 0/20 • 6 months	13.6% 3/22 • Number of events 3 • 6 months
Gastrointestinal disorders Gastrointestinal problems - constipation	15.0% 3/20 • Number of events 5 • 6 months	9.1% 2/22 • Number of events 2 • 6 months
Gastrointestinal disorders Gastrointestinal problems - decreased appetite	0.00% 0/20 • 6 months	9.1% 2/22 • Number of events 2 • 6 months
General disorders Mental health problems - emotional discomfort	15.0% 3/20 • Number of events 4 • 6 months	4.5% 1/22 • Number of events 1 • 6 months
Nervous system disorders Other problems - headache	10.0% 2/20 • Number of events 2 • 6 months	13.6% 3/22 • Number of events 5 • 6 months
Respiratory, thoracic and mediastinal disorders Other problems - breathing problems	10.0% 2/20 • Number of events 2 • 6 months	13.6% 3/22 • Number of events 3 • 6 months
Skin and subcutaneous tissue disorders Other problems - rash	10.0% 2/20 • Number of events 2 • 6 months	4.5% 1/22 • Number of events 1 • 6 months
Eye disorders Other problems - blurry vision or vision loss	0.00% 0/20 • 6 months	9.1% 2/22 • Number of events 4 • 6 months
General disorders Other problems - sleep problems	15.0% 3/20 • Number of events 3 • 6 months	22.7% 5/22 • Number of events 6 • 6 months
General disorders Other problems - drowsiness	15.0% 3/20 • Number of events 3 • 6 months	18.2% 4/22 • Number of events 5 • 6 months
General disorders Other problems - weight gain or loss	10.0% 2/20 • Number of events 2 • 6 months	18.2% 4/22 • Number of events 6 • 6 months
General disorders Other problems - bowel or bladder changes	10.0% 2/20 • Number of events 3 • 6 months	13.6% 3/22 • Number of events 3 • 6 months
General disorders Other problems - bruising	0.00% 0/20 • 6 months	13.6% 3/22 • Number of events 3 • 6 months
General disorders Other problems - weakness	10.0% 2/20 • Number of events 2 • 6 months	9.1% 2/22 • Number of events 4 • 6 months
General disorders Other problems - clumsiness	5.0% 1/20 • Number of events 1 • 6 months	9.1% 2/22 • Number of events 2 • 6 months

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