Low Back PainSUPPORTNCT05022121
Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain
A study testing Supported Biopsychosocial Self-Management (SBSM) and Medical Care in people with Low Back Pain and Sciatica, run by University of Minnesota at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Sciatica, Back Related Leg Pain
- What is being tested?
- Supported Biopsychosocial Self-Management (SBSM) and Medical Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Jan 2022to 20 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Minnesota
Minneapolis, Minnesota, 55455
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
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).
- Conditions
- Low Back Pain, Sciatica, Back Related Leg Pain, Pain, Chronic, Intervertebral Disc Displacement
- Being tested
- Supported Biopsychosocial Self-Management (SBSM), Medical Care
- Medical subject headings
- Low Back Pain, Sciatica, Chronic Pain, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supported Biopsychosocial Self-Management (SBSM)Behavioural
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 CareDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Supported Biopsychosocial Self-Management (SBSM) | Experimental | Supported Biopsychosocial Self-Management (SBSM) Receives: Behavioral: Supported Biopsychosocial Self-Management (SBSM) |
| Medical Care | Active comparator | Medical Care Receives: Drug: Medical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Particpants Screened Per Month
As a measure of recruitment feasibility, the average number of participants screened per month is reported
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 month period of active enrollment
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through completion of all weekly assessments, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start26 Jan 2022
- Primary completion20 Feb 2023
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, Duke University, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Linda Hanson, DC, MS, Study director, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022121
- Sponsor's protocol ID
- CSH-2021-30117
- Other IDs
- R34AT011209
- Acronym
- SUPPORT
- Status last verified
- Feb 2024
- First submitted
- 18 May 2021
- Last updated
- 15 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain
- ClinicalTrials.gov ID
- NCT05022121
- Acronym / sponsor ID
- SUPPORT / CSH-2021-30117
- Conditions
- Low Back Pain, Sciatica, Back Related Leg Pain, Pain, Chronic, Intervertebral Disc Displacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- University of Pittsburgh, Duke University, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 26 Aug 2021 (actual)
- Results
- Posted 15 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supported Biopsychosocial Self-Management (SBSM) | Experimental | Behavioral: Supported Biopsychosocial Self-Management (SBSM)Supported Biopsychosocial Self-Management (SBSM) |
| Medical Care | Active comparator | Drug: Medical CareMedical Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Supported Biopsychosocial Self-Management (SBSM) |
| Medical CareMedical 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. | Drug | Medical Care |
Primary outcome
Number of Particpants Screened Per Month
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Hanson, DC, MS study director
University of Minnesota
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supported Biopsychosocial Self-Management (SBSM) and Medical Care in people with Low Back Pain and Sciatica, run by University of Minnesota at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Particpants Screened Per Month (time frame: 6 month period of active study screening). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.