Low Back Pain, Sciatica, Back Related Leg Pain, Pain, Chronic, Intervertebral Disc Displacement
Conditions
Brief summary
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).
Interventions
BEHAVIORALSupported 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.
DRUGMedical 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.
Sponsors
University of Pittsburgh
Duke University
National Center for Complementary and Integrative Health (NCCIH)
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Back-related leg pain (BRLP) consistent with the Quebec Task Force (QTF) classifications 2-4 (radiating pain into proximal or distal extremity with or without neurological signs). * 18 years of age or older. * Back-related leg pain severity of 3 or higher at all screening assessments (0 to 10 scale) * Episode duration of 12 weeks or more * Ability to read English fluently
Exclusion criteria
* Spinal stenosis (QTF 7) * Specific, non-mechanical causes of BRLP (QTF 11; e.g. infection, tumor) * Contraindications to study interventions (e.g. spinal fracture (QTF 5)) * Inflammatory conditions of the lumbar spine (QTF 11) * Lumbar fusion * Progressive neurological deficits * Cauda equina syndrome * Pregnancy, nursing * Ongoing care from another healthcare provider for BRLP * Severe unmanaged comorbid conditions (e.g. substance abuse, major depressive disorder, stage 3 hypertension).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Particpants Screened Per Month | 6 month period of active study screening | As a measure of recruitment feasibility, the average number of participants screened per month is reported |
| Percentage of Screened Participants Who Are Female | 6 month period of active study screening | As a measure of recruitment feasibility, the number of female participants in the study is reported |
| Percentage of Screened Participants Who Are From Racial or Ethnic Minority Populations | 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. |
| Number of Participants Enrolled Per Month | 6 month period of active study screening | As a measure of enrollment feasibility, the average number of participants recruited per month is reported. |
| Percentage of Enrolled Participants Who Are Female | 6 month period of active study enrollment | As a measure of enrollment feasibility, the number of female participants enrolled in the study is reported. |
| Percentage of Enrolled Participants Who Are From Racial or Ethnic Minority Populations | 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. |
| Percentage of Enrollees Not Receiving Any Treatment | 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. |
| Percentage of Enrollees Receiving Prohibited Treatments | 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. |
| Percentage of Enrollees Satisfied With Treatment | 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. |
| Percentage of Enrollees Attending Required Sessions | 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. |
| Percentage of Enrollees in Supported Biopsychosocial Self-management Group Reporting Participation in Home Practice | 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. |
| Percentage of Enrollees in Medical Care Group Reporting Taking Medications as Prescribed | 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. |
| Percentage of Provider Visits Where All Required Intervention Activities Were Delivered | 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. |
| Percentage of Enrollees Completing the Month 3 Assessment | Month 3 assessment | As a measure of data collection feasibility, the number of enrollees completing the month 3 assessment is reported. |
| Percentage of Enrollees Completing the Month 6 Assessment | Month 6 assessment | As a measure of data collection feasibility, the number of enrollees completing the month 6 assessment is reported. |
| Percentage of Weekly Pain Severity and Frequency Assessments Completed | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 22 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 2 |
Baseline characteristics
| Characteristic | Medical Care | Total | Supported Biopsychosocial Self-Management (SBSM) |
|---|---|---|---|
| Age, Continuous | 51.6 years STANDARD_DEVIATION 14 | 52.9 years STANDARD_DEVIATION 14.2 | 54.3 years STANDARD_DEVIATION 14.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 40 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 33 Participants | 18 Participants |
| Sex: Female, Male Female | 14 Participants | 25 Participants | 11 Participants |
| Sex: Female, Male Male | 8 Participants | 17 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 22 |
| other Total, other adverse events | 12 / 20 | 14 / 22 |
| serious Total, serious adverse events | 0 / 20 | 2 / 22 |
Outcome results
Primary
Number of Participants Enrolled Per Month
As a measure of enrollment feasibility, the average number of participants recruited per month is reported.
Time frame: 6 month period of active study screening
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Screened Participants | Number of Participants Enrolled Per Month | 7 participants per month |
Primary
Number of Particpants Screened Per Month
As a measure of recruitment feasibility, the average number of participants screened per month is reported
Time frame: 6 month period of active study screening
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Screened Participants | Number of Particpants Screened Per Month | 103 participants per month |
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.
Time frame: 6 month period of active study enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screened Participants | Percentage of Enrolled Participants Who Are Female | 25 Participants |
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.
Time frame: 6 month period of active enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screened Participants | Percentage of Enrolled Participants Who Are From Racial or Ethnic Minority Populations | 8 Participants |
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.
Time frame: Through study treatment, an average of 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screened Participants | Percentage of Enrollees Attending Required Sessions | 19 Participants |
| Medical Care | Percentage of Enrollees Attending Required Sessions | 20 Participants |
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.
Time frame: Month 3 assessment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screened Participants | Percentage of Enrollees Completing the Month 3 Assessment | 18 Participants |
| Medical Care | Percentage of Enrollees Completing the Month 3 Assessment | 20 Participants |
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.
Time frame: Month 6 assessment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screened Participants | Percentage of Enrollees Completing the Month 6 Assessment | 18 Participants |
| Medical Care | Percentage of Enrollees Completing the Month 6 Assessment | 20 Participants |
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.
Time frame: Through study treatment, an average of 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screened Participants | Percentage of Enrollees in Medical Care Group Reporting Taking Medications as Prescribed | 17 Participants |
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.
Time frame: Through study treatment, an average of 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screened Participants | Percentage of Enrollees in Supported Biopsychosocial Self-management Group Reporting Participation in Home Practice | 19 Participants |
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.
Time frame: Through study treatment, an average of 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screened Participants | Percentage of Enrollees Not Receiving Any Treatment | 0 Participants |
| Medical Care | Percentage of Enrollees Not Receiving Any Treatment | 1 Participants |
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.
Time frame: Through study treatment, an average of 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screened Participants | Percentage of Enrollees Receiving Prohibited Treatments | 1 Participants |
| Medical Care | Percentage of Enrollees Receiving Prohibited Treatments | 1 Participants |
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.
Time frame: Through study treatment, an average of 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screened Participants | Percentage of Enrollees Satisfied With Treatment | 17 Participants |
| Medical Care | Percentage of Enrollees Satisfied With Treatment | 14 Participants |
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.
Time frame: Through study treatment, an average of 3 months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Screened Participants | Percentage of Provider Visits Where All Required Intervention Activities Were Delivered | 111 Visits |
| Medical Care | Percentage of Provider Visits Where All Required Intervention Activities Were Delivered | 79 Visits |
Primary
Percentage of Screened Participants Who Are Female
As a measure of recruitment feasibility, the number of female participants in the study is reported
Time frame: 6 month period of active study screening
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screened Participants | Percentage of Screened Participants Who Are Female | 414 Participants |
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.
Time frame: 6 month period of active study screening
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screened Participants | Percentage of Screened Participants Who Are From Racial or Ethnic Minority Populations | 168 Participants |
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.
Time frame: Through completion of all weekly assessments, an average of 6 months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Screened Participants | Percentage of Weekly Pain Severity and Frequency Assessments Completed | 461 Weekly Surveys |
| Medical Care | Percentage of Weekly Pain Severity and Frequency Assessments Completed | 479 Weekly Surveys |