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Completed

NCT Number: NCT04411420

Improving Veteran Access to Integrated Management of Back Pain

The purpose and objective of this pragmatic trial is to examine the effectiveness of two different quality improvement care pathways for low back pain (LBP); a sequenced, integrated care pathway (ICP) and 2) a coordinated, care management pathway (CCP). We will test the central hypothesis that the ICP will reduce pain interference with normal activities and improve physical function, as measured by Patient Reported Outcomes Measurement Information System (PROMIS) Short Form scores when compared to the CCP.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Durham VA

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pain modulation with physical pain treatment

Behavioral

Examples of pain modulation with physical pain treatment include spinal manipulation, massage, or transcutaneous electrical nerve stimulation

Telephone delivered self-management counseling for increasing physical activity

Behavioral

Centrally located physical therapy assistants will provide six weeks of telehealth consults to increase physical activity for the patient

Telephone delivered behavioral treatment for participants with high risk for continued disability

Behavioral

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.

Patient preference treatment protocol

Behavioral

the pain navigator will work through a shared decision making process with the patient to determine the preferred treatment protocol

Nonpharmacological guideline adherent treatment protocol

Behavioral

the pain navigator will select only nonpharmacological guideline adherent treatment options for the patient

Facilitated referrals to existing VA or non-VA pain management resources

Behavioral

the pain navigator will work with the referring physician to select only existing VA or non-VA pain management resources for the patient.

Primary outcomes

  1. Change in Pain Interference Measure

    Time frame: Baseline, three months post baseline

    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. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. With the revised statistical analysis plan, the patient reported outcomes survey data were used to supplement missing three month follow up data from the medical record, when possible. A higher score indicates greater pain interference.

  2. Change in Physical Function Measure

    Time frame: Baseline, three months post baseline

    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 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. With the revised statistical analysis plan, the patient reported outcomes survey data were used to supplement missing three month follow up data from the medical record, when possible. A higher score indicates better physical function.

Secondary outcomes

  1. Change in Sleep Disturbance

    Time frame: Baseline, three months post baseline

    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 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. With the revised statistical analysis plan, the patient reported outcomes survey data were used to supplement missing three month follow up data from the medical record, when possible. A higher score indicates greater sleep disturbance.

  2. Change in Patient Reported Outcomes--PROMIS Sleep Disturbance

    Time frame: Baseline, three, six, and twelve months

    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 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. A higher score indicates greater sleep disturbance.

  3. Number of Participants With Opioid Use--Chronic User

    Time frame: Baseline, twelve months post baseline

    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. Opioid use is chronic if participant had at least one prescription with a total day supply of at least 120 days or if there were at least 10 prescription fills in the 12 months prior to the specified timepoint (baseline, 12 months post baseline).

  4. Change in Opioid Use - Morphine Dose

    Time frame: Baseline, twelve months post baseline

    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. Change in total milligrams of morphine equivalents (MME) use is reported.

  5. Change in Patient Reported Outcomes--PROMIS Pain Interference

    Time frame: Baseline, three, six, and twelve months

    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 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. A higher score indicates greater pain interference.

  6. Change in Patient Reported Outcomes--PROMIS Physical Function

    Time frame: Baseline, three, six, and twelve months

    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 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. A higher score indicates better physical function.

Other outcomes

  1. Change in Patient Reported Outcomes--Catastrophizing

    Time frame: Baseline, three, six, and twelve months

    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 two agree (1) / disagree (0) questions. Responses marked as DK/Ref/Missing are coded as missing. Responses are then summed across the two questions; possible outcome values are 0, 1, 2. A higher score indicates greater catastrophizing.

  2. Change in Patient Reported Outcomes--Alcohol Use Disorders Identification Test Concise (AUDIT-C)

    Time frame: Baseline, three, six, and twelve months

    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 three alcohol use questions on a scale of 0-4 with zero representing a better outcome. The total score is the sum of the non-missing responses to the three questions, with range of possible values 0-12.

  3. Change in Patient Reported Outcomes--Pain Intensity, Enjoyment of Life, General Activity (PEG) Screening Tool

    Time frame: Baseline, three, six, and twelve months

    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. The total score is the sum of responses to the three questions and is missing if any of the three questions is missing. The range of possible values is 0-30.

  4. Change in Patient Reported Outcomes--Pain Self Efficacy Questionnaire (PSEQ-2)

    Time frame: Baseline, three, six, and twelve months

    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. The total score is the sum of responses to the two questions and is missing if either of the two questions is missing. The range of possible values is 0-12.

  5. Change in Patient Reported Outcomes--Depressed Mood

    Time frame: Baseline, three, six, and twelve months

    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 with ratings between 0 and 3. The total score is the sum of responses to the two questions and is missing if either of the two questions is missing. The range of possible values is 0-6. A higher score indicates greater depressed mood.

  6. Change in Patient Reported Outcomes--Quality of Life

    Time frame: Baseline, three, six, and twelve months

    The EuroQoL five-item quality of life questionnaire, EQ-5D-5L, will be administered by interviewers at baseline, three, six, and twelve months post baseline to measure quality of life. The EQ-5D-5L asks the participant five questions related to quality of life on a scale of 1-5. If all questions are answered, the responses are concatenated to form a 5-digit state in the order mobility, self care, usual activities, pain discomfort, anxiety/depression. This 5-digit state is then converted to an index between 0 and 1. A higher score indicates greater quality of life.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Durham VA Medical Center
  • National Center for Complementary and Integrative Health (NCCIH)
  • University of North Carolina, Chapel Hill

Registry information

Official study title

Improving Veteran Access to Integrated Management of Back Pain: A Pragmatic, Cluster Randomized Trial

Acronym: AIM-BACK

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Jun 2, 2020
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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