Comparing Non-Medicine Strategies for Improving Low Back Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University
About this trial
The goal of this clinical trial is to help veterans manage high-impact chronic pain (HICP) in the lower back. The trial will use a program, ENCompaSS (Education, Navigated Care, and Supported Self-Management) designed to reduce pain more than usual care alone. Researchers will assess a) the impact of ENCompaSS, b) identify which veterans benefit the most, and c) how this program can be delivered more broadly in other clinics and health systems.
What Will Happen:
Veterans in this clinical trial will be randomly placed into one of two groups.
ENCompaSS group (intervention):
* Have at least three phone calls with a trained clinician over about 12 weeks * Watch short online videos about managing pain * Complete surveys before the study and again at 2, 4, 6, and 12 months
Usual Stepped Care group:
* Will continue with regular care * Complete the same surveys at the same time points
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be age 18 years old or older
Have a VA outpatient clinic visit for low back pain within the previous 30 days
Be enrolled in a participating primary care clinic
Have high impact chronic pain per Graded Chronic Pain Scale (most days or every day on first 2 items)
Disqualifiers
Are currently hospitalized or residing in a nursing home
Have cognitive impairment or lack of decision-making capacity
Have a serious mental illness (e.g., schizophrenia, bipolar disorder, recent psychiatric hospitalization, high risk suicide flag)
Are unable to communicate by telephone or have no telephone access
Trial design
Design model
Parallel
Treatments tested in this trial
ENCompaSS (Education, Navigated Care, and Supported Self-Management) with VA Stepped Usual Care
Other interventionThe ENCompaSS pain program was designed based on the Chronic Care Model (CCM), a widely used framework for organizing care for people with chronic diseases. In this model, the care provided for low back pain (LBP) meeting criteria for high-impact chronic pain (HICP), intentionally brings together the patient, provider, and system interventions necessary to accomplish the overall goal of improving pain outcomes and related co-morbidities. Our previous experiences with navigation in a previous study were only partially represented in the CCM. ENCompaSS employs a more comprehensive blend of CCM elements, incorporating important domains such Self-Management Support, which we posit will result in better pain interference outcomes.
Treatment groups
530 Participants
are divided into 2 treatment groupsGroup A: ENCompaSS + VA Usual Stepped CareActive comparator 1 intervention
Group B: VA Usual Stepped CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Pain interference with normal activities as assessed by PROMIS (Patient-Reported Outcomes Measurement Information System) Short Form 8a v1.0 score
The validated PROMIS Pain Interference instrument measures the self-reported consequences of pain across aspects of life including social, cognitive, emotional, physical, and recreational activities. 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. A higher score indicates greater pain interference.
Time frame
From enrollment to 6 MonthsSecondary outcomes
1
Average Ratings of Self-Reported Sleep Quality
Sleep quality assessed by the PROMIS 4-item short form: 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. A higher score indicates greater sleep disturbance.
Time frame
Baseline to 6 Months2
Average Ratings of Self-Reported Physical Function
Physical function assessed by the PROMIS 4-item short form: 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. A higher score indicates better physical function.
Time frame
Baseline to 6 Months3
Average Self-Reported Pain Intensity Ratings
Pain intensity assessed by the PROMIS short form: Pain intensity is a standardized, 3-question survey used to quantify how much a patient is hurting. It evaluates three parameters: average pain in the past 7 days, worst pain in the past 7 days, and current pain. Patients receive a raw total score ranging from 3 to 15, where higher scores indicate greater pain severity.
Time frame
Baseline to 6 Months4
Average Self-Reported Endorsement of Depression Symptoms
Depression assessed by the PROMIS 4-item short form: The depression form measures self-reported negative mood, feelings of worthlessness, and loss of interest over the past seven days 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. A higher score indicates more depression.
Time frame
Baseline to 6 MonthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Duke University
Lead sponsor
Durham VA Medical Center
Collaborator
Indiana University
Collaborator
University of Arizona
Collaborator
Dallas VA Medical Center
Collaborator
Source ClinicalTrials.gov
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