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| ID | Type | Description | Link |
|---|---|---|---|
| R34AT011209 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Pittsburgh | OTHER |
| Duke University | OTHER |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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Guidelines advocate several complementary modalities as alternatives to drugs and other invasive treatments for chronic low back pain (LBP) conditions. However, there is little high-quality research investigating treatments for back-related leg pain, one of the more severe and disabling presentations of LBP. The investigators are conducting a pilot study to assess the feasibility of a future phase II multi-site randomized clinical trial (RCT). The future trial will assess the comparative effectiveness of a novel supported biopsychosocial self-management (SBSM) intervention versus Medical Care (MC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supported Biopsychosocial Self-Management (SBSM) | Experimental | Supported Biopsychosocial Self-Management (SBSM) |
|
| Medical Care | Active Comparator | Medical Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supported Biopsychosocial Self-Management (SBSM) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Particpants Screened Per Month | As a measure of recruitment feasibility, the average number of participants screened per month is reported | 6 month period of active study screening |
| Percentage of Screened Participants Who Are Female | As a measure of recruitment feasibility, the number of female participants in the study is reported | 6 month period of active study screening |
| Percentage of Screened Participants Who Are From Racial or Ethnic Minority Populations | As a measure of recruitment feasibility, the number of participants from racial or ethnic minority populations is reported. | 6 month period of active study screening |
| Number of Participants Enrolled Per Month | As a measure of enrollment feasibility, the average number of participants recruited per month is reported. | 6 month period of active study screening |
| Percentage of Enrolled Participants Who Are Female | As a measure of enrollment feasibility, the number of female participants enrolled in the study is reported. | 6 month period of active study enrollment |
| Percentage of Enrolled Participants Who Are From Racial or Ethnic Minority Populations | As a measure of enrollment feasibility, the number of participants enrolled from racial or ethnic minority populations is reported. | 6 month period of active enrollment |
| Percentage of Enrollees Not Receiving Any Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda Hanson, DC, MS | University of Minnesota | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States | ||
| University of Pittsburgh |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Particpants Screened Per Month | As a measure of recruitment feasibility, the average number of participants screened per month is reported | Posted | Mean | Full Range | participants per month | 6 month period of active study screening |
|
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fracture injury after fall | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back problems - soreness/stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brent Leininger | University of Minnesota | 6126266477 | lein0122@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 18, 2022 | Feb 8, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 19, 2021 | Feb 23, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D012585 | Sciatica |
| D059350 | Chronic Pain |
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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|
| Medical Care | Drug | 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. |
|
As a measure of intervention acceptability and credibility associated with feasibility, the number of enrollees not receiving any treatment is reported. |
| Through study treatment, an average of 3 months |
| Percentage of Enrollees Receiving Prohibited Treatments | 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. | Through study treatment, an average of 3 months |
| Percentage of Enrollees Satisfied With Treatment | 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. | Through study treatment, an average of 3 months |
| Percentage of Enrollees Attending Required Sessions | 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. | Through study treatment, an average of 3 months |
| Percentage of Enrollees in Supported Biopsychosocial Self-management Group Reporting Participation in Home Practice | 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. | Through study treatment, an average of 3 months |
| Percentage of Enrollees in Medical Care Group Reporting Taking Medications as Prescribed | 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. | Through study treatment, an average of 3 months |
| Percentage of Provider Visits Where All Required Intervention Activities Were Delivered | As a measure of provider fidelity, the percentage of provider vists where 100% of required intervention activities were delivered is reported. | Through study treatment, an average of 3 months |
| Percentage of Enrollees Completing the Month 3 Assessment | As a measure of data collection feasibility, the number of enrollees completing the month 3 assessment is reported. | Month 3 assessment |
| Percentage of Enrollees Completing the Month 6 Assessment | As a measure of data collection feasibility, the number of enrollees completing the month 6 assessment is reported. | Month 6 assessment |
| Percentage of Weekly Pain Severity and Frequency Assessments Completed | As a measure of data collection feasibility, the number of weekly pain severity and frequency assessments completed by participants is reported. | Through completion of all weekly assessments, an average of 6 months |
| Pittsburgh |
| Pennsylvania |
| 15260 |
| United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| Primary | Percentage of Screened Participants Who Are Female | As a measure of recruitment feasibility, the number of female participants in the study is reported | Posted | Count of Participants | Participants | 6 month period of active study screening |
|
|
|
| Primary | Percentage of Screened Participants Who Are From Racial or Ethnic Minority Populations | As a measure of recruitment feasibility, the number of participants from racial or ethnic minority populations is reported. | Posted | Count of Participants | Participants | 6 month period of active study screening |
|
|
|
| Primary | Number of Participants Enrolled Per Month | As a measure of enrollment feasibility, the average number of participants recruited per month is reported. | Posted | Mean | Full Range | participants per month | 6 month period of active study screening |
|
|
|
| Primary | Percentage of Enrolled Participants Who Are Female | As a measure of enrollment feasibility, the number of female participants enrolled in the study is reported. | Posted | Count of Participants | Participants | 6 month period of active study enrollment |
|
|
|
| Primary | Percentage of Enrolled Participants Who Are From Racial or Ethnic Minority Populations | As a measure of enrollment feasibility, the number of participants enrolled from racial or ethnic minority populations is reported. | Posted | Count of Participants | Participants | 6 month period of active enrollment |
|
|
|
| Primary | Percentage of Enrollees Not Receiving Any Treatment | As a measure of intervention acceptability and credibility associated with feasibility, the number of enrollees not receiving any treatment is reported. | Posted | Count of Participants | Participants | Through study treatment, an average of 3 months |
|
|
|
| Primary | Percentage of Enrollees Receiving Prohibited Treatments | 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. | Posted | Count of Participants | Participants | Through study treatment, an average of 3 months |
|
|
|
| Primary | Percentage of Enrollees Satisfied With Treatment | 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. | Posted | Count of Participants | Participants | Through study treatment, an average of 3 months |
|
|
|
| Primary | Percentage of Enrollees Attending Required Sessions | 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. | Posted | Count of Participants | Participants | Through study treatment, an average of 3 months |
|
|
|
| Primary | Percentage of Enrollees in Supported Biopsychosocial Self-management Group Reporting Participation in Home Practice | 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. | Posted | Count of Participants | Participants | Through study treatment, an average of 3 months |
|
|
|
| Primary | Percentage of Enrollees in Medical Care Group Reporting Taking Medications as Prescribed | 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. | Posted | Count of Participants | Participants | Through study treatment, an average of 3 months |
|
|
|
| Primary | Percentage of Provider Visits Where All Required Intervention Activities Were Delivered | As a measure of provider fidelity, the percentage of provider vists where 100% of required intervention activities were delivered is reported. | Posted | Count of Units | Visits | Through study treatment, an average of 3 months | Visits | Visits |
|
|
|
| Primary | Percentage of Enrollees Completing the Month 3 Assessment | As a measure of data collection feasibility, the number of enrollees completing the month 3 assessment is reported. | Posted | Count of Participants | Participants | Month 3 assessment |
|
|
|
| Primary | Percentage of Enrollees Completing the Month 6 Assessment | As a measure of data collection feasibility, the number of enrollees completing the month 6 assessment is reported. | Posted | Count of Participants | Participants | Month 6 assessment |
|
|
|
| Primary | Percentage of Weekly Pain Severity and Frequency Assessments Completed | As a measure of data collection feasibility, the number of weekly pain severity and frequency assessments completed by participants is reported. | Posted | Count of Units | Weekly Surveys | Through completion of all weekly assessments, an average of 6 months | Weekly Surveys | Weekly Surveys |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 12 |
| 20 |
| EG001 | 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. | 0 | 22 | 2 | 22 | 14 | 22 |
| Back problems - new back or leg pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back problems - increased back or leg pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back problems - numbness or tingling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Gastrointestinal problems - dry mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal problems - indigestion | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal problems - abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal problems - reflux | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal problems - constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal problems - decreased appetite | Gastrointestinal disorders | Systematic Assessment |
|
| Mental health problems - emotional discomfort | General disorders | Systematic Assessment |
|
| Other problems - headache | Nervous system disorders | Systematic Assessment |
|
| Other problems - breathing problems | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Other problems - rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Other problems - blurry vision or vision loss | Eye disorders | Systematic Assessment |
|
| Other problems - sleep problems | General disorders | Systematic Assessment |
|
| Other problems - drowsiness | General disorders | Systematic Assessment |
|
| Other problems - weight gain or loss | General disorders | Systematic Assessment |
|
| Other problems - bowel or bladder changes | General disorders | Systematic Assessment |
|
| Other problems - bruising | General disorders | Systematic Assessment |
|
| Other problems - weakness | General disorders | Systematic Assessment |
|
| Other problems - clumsiness | General disorders | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D020426 | Sciatic Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009437 | Neuralgia |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |