- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04411420
Improving Veteran Access to Integrated Management of Back Pain (AIM-BACK)
Improving Veteran Access to Integrated Management of Back Pain: A Pragmatic, Cluster Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
- Behavioral: Pain modulation with physical pain treatment
- Behavioral: Telephone delivered self-management counseling for increasing physical activity
- Behavioral: Telephone delivered behavioral treatment for participants with high risk for continued disability
- Behavioral: Patient preference treatment protocol
- Behavioral: Nonpharmacological guideline adherent treatment protocol
- Behavioral: Facilitated referrals to existing VA or non-VA pain management resources
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Leo Brothers, MPH
- Phone Number: 919-668-8322
- Email: joseph.l.brothers@duke.edu
Study Contact Backup
- Name: Catherine Stanwyck
- Email: catherine.stanwyck@va.gov
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27705
- Durham VA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Clinic eligibility:
- Volunteer and return signed clinic participation agreement
- Availability of clinical personnel willing to deliver the treatment interventions (in either arm).
- Staff and location need to be distinct from other enrolled clinics.
- Clinics can have a variable number of providers, but together meet criteria for range of monthly visits for low back pain.
Participant Survey Eligibility Criteria:
Inclusion Criteria:
- Age >= 18
- Seeking care for LBP with or without radiating symptoms from a participating VA primary care clinic
- Provider determines LBP is appropriate for conservative management
- Referred to integrated ICP pathway or CCP pathway by participating clinic provider
Exclusion Criteria:
- Receiving or referred for hospice/ palliative care (defined by encounter codes and CPRS consults)
- No documented phone number in the electronic health record.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Integrated Care Pathway
The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.
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Examples of pain modulation with physical pain treatment include spinal manipulation, massage, or transcutaneous electrical nerve stimulation
Centrally located physical therapy assistants will provide six weeks of telehealth consults to increase physical activity for the patient
Patients with a higher risk of developing chronic or persistent back pain will be identified using the nine question risk stratification start back screening tool (SBST) and will receive six additional weeks of physical activity instructions and additional pain modulation treatments as needed.
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Active Comparator: Coordinated Care Management Pathway
The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.
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the pain navigator will work through a shared decision making process with the patient to determine the preferred treatment protocol
the pain navigator will select only nonpharmacological guideline adherent treatment options for the patient
the pain navigator will work with the referring physician to select only existing VA or non-VA pain management resources for the patient.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pain Interference Measure
Time Frame: Baseline, three months post baseline
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The PROMIS Short form scores will be collected by the clinical providers within the medical record at baseline and three months to measure pain interference.
The pain interference form asks the participant to rate a series of pain related questions on a scale of 1-5 within the past seven days with 1 representing a better outcome.
With the revised statistical analysis plan, the patient reported outcomes survey data will be used to supplement missing three month follow up data from the medical record, when possible.
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Baseline, three months post baseline
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Change in Physical Function Measure
Time Frame: Baseline, three months post baseline
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The PROMIS Short form scores will be collected by the clinical providers within the medical record at baseline and three months to measure physical function.
The physical function form asks the participant to rate a series of physical function related questions on a scale of 1-5 within the past seven days with one representing a better outcome.
With the revised statistical analysis plan, the patient reported outcomes survey data will be used to supplement missing three month follow up data from the medical record, when possible.
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Baseline, three months post baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Sleep Disturbance
Time Frame: Baseline, three months post baseline
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The PROMIS Short form scores will be collected in the medical record by the provider at baseline, and three months post baseline to measure sleep disturbance.
The sleep disturbance form asks the participant to rate a series of sleep related questions on a scale of 1-5 with one representing a better outcome
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Baseline, three months post baseline
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Change in Opioid Use--Chronic User
Time Frame: Baseline, twelve months post baseline
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opioid use will be defined at baseline and 12 months post baseline as a binary variable based on whether a chronic opioid user or not at baseline and at twelve months
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Baseline, twelve months post baseline
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Change in Opioid Use--Morphine Dose
Time Frame: Baseline, twelve months post baseline
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opioid use--morphine dose will be defined at baseline and 12 months post baseline as a continuous variable measuring morphine equivalents for opioid dose at baseline and twelve months
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Baseline, twelve months post baseline
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Change in Patient reported Outcomes--PROMIS Sleep Disturbance
Time Frame: Baseline, three, six, and twelve months
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The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure sleep disturbance.
The sleep disturbance form asks the participant to rate a series of sleep related questions on a scale of 1-5 with one representing a better outcome
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Baseline, three, six, and twelve months
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Change in Patient Reported Outcomes--PROMIS Pain Interference
Time Frame: Baseline, three, six, and twelve months
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The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure pain interference.
The pain interference form asks the participant to rate a series of pain related questions on a scale of 1-5 within the past seven days with one representing a better outcome
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Baseline, three, six, and twelve months
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Change in Patient Reported Outcomes--PROMIS Physical Function
Time Frame: Baseline, three, six, and twelve months
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The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure physical function.
The physical function form asks the participant to rate a series of physical function related questions on a scale of 1-5 with one representing a better outcome.
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Baseline, three, six, and twelve months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Patient Reported Outcomes--Catastrophizing
Time Frame: Baseline, three, six, and twelve months
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Catastrophizing questions from the NIH recommended minimum data set will be collected by the interviewers at baseline, three, six, and twelve months post baseline and will evaluate catastrophizing with several agree / disagree questions.
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Baseline, three, six, and twelve months
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Change in Patient Reported Outcomes--Alcohol Use Disorders Identification Test Concise (AUDIT-C)
Time Frame: Baseline, three, six, and twelve months
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The AUDIT-C form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure alcohol use.
The AUDIT-C form asks the participant to rate a series of alcohol use questions on a scale of 0-4 with zero representing a better outcome
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Baseline, three, six, and twelve months
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Change in Patient Reported Outcomes--Pain intensity, Enjoyment of life, general activity (PEG) screening tool
Time Frame: Baseline, three, six, and twelve months
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The PEG screening tool scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure pain intensity.
The PEG form asks the participant to rate a series of pain intensity related questions on a scale of 0-10 with 0 representing a better outcome
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Baseline, three, six, and twelve months
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Change in Patient Reported Outcomes--Pain Self Efficacy Questionnaire (PSEQ-2)
Time Frame: Baseline, three, six, and twelve months
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Pain Self-Efficacy Questionnaire from the PSEQ-2 form will be collected by the interviewers at baseline, three, six, and twelve months post baseline and will evaluate self-efficacy on a scale of 0-6 with zero representing a worse outcome.
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Baseline, three, six, and twelve months
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Change in Patient Reported Outcomes--Depressed Mood
Time Frame: Baseline, three, six, and twelve months
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The Patient Health Questionnaire-2 (PHQ2) form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure depressed mood.
The PHQ2 form asks the participant to answer two questions about potential depressed mood within the past week.
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Baseline, three, six, and twelve months
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Change in Patient Reported Outcomes--Quality of Life
Time Frame: Baseline, three, six, and twelve months
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The EUROQUOL five item quality of life questionnaire will be administered by interviewers at baseline, three, six, and twelve months post baseline to measure quality of life.
The EUROQUOL asks the participant a series of questions related to quality of life on a scale of 0-5.
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Baseline, three, six, and twelve months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Susan N Hastings, MD, Duke University / Durham VA
- Principal Investigator: Steven Z George, PT, PhD, Duke University
Publications and helpful links
General Publications
- George SZ, Coffman CJ, Allen KD, Lentz TA, Choate A, Goode AP, Simon CB, Grubber JM, King H, Cook CE, Keefe FJ, Ballengee LA, Naylor J, Brothers JL, Stanwyck C, Alkon A, Hastings SN. Improving Veteran Access to Integrated Management of Back Pain (AIM-Back): Protocol for an Embedded Pragmatic Cluster-Randomized Trial. Pain Med. 2020 Dec 12;21(Suppl 2):S62-S72. doi: 10.1093/pm/pnaa348.
- Ballengee LA, King HA, Simon C, Lentz TA, Allen KD, Stanwyck C, Gladney M, George SZ, Hastings SN. Partner engagement for planning and development of non-pharmacological care pathways in the AIM-Back trial. Clin Trials. 2023 Oct;20(5):463-472. doi: 10.1177/17407745231178789. Epub 2023 Jun 2.
- Lentz TA, Coffman CJ, Cope T, Stearns Z, Simon CB, Choate A, Gladney M, France C, Hastings SN, George SZ. If You Build It, Will They Come? Patient and Provider Use of a Novel Hybrid Telehealth Care Pathway for Low Back Pain. Phys Ther. 2024 Feb 1;104(2):pzad127. doi: 10.1093/ptj/pzad127.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00101938
- UH3AT009790 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
We plan on using a de-identified dataset is not subject to HIPAA's minimum necessary standards and would not require a data use agreement. Typically datasets will be provided in SAS transport files using CDISC standards via a website. Requesters will have to enter a valid email, phone number and address to request data. The data provided will be made available under certain requirements and approved on a case by case basis. Requirements include:
- data will be used for research purposes and not to identify subjects
- data must be secured using appropriate computer technology
- data must be destroyed or returned after any analysis are complete
- authors of any manuscript resulting from this data must acknowledge the source of the data
- analyses for the purpose of presentations, abstracts, and/or publications must be coordinated through the Publications Committee, to avoid overlap
- coauthors must be given a chance for review and approval of a draft manuscript prior to submission
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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