ENCompaSS Program for Chronic Low Back Pain

(ENCompaSS Trial)

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help veterans manage chronic low back pain through a program called ENCompaSS (Education, Navigated Care, and Supported Self-Management), which includes education, care navigation, and self-management support. Participants will either join this program with personalized phone support and educational videos or continue with their usual care. The trial compares these two approaches to determine which is more effective in reducing pain and improving life quality. Veterans who experience frequent or daily chronic low back pain and have recently visited a VA clinic for it might be a good fit for this study. As an unphased trial, this study offers veterans the opportunity to explore innovative pain management strategies that could enhance their quality of life.

What prior data suggests that the ENCompaSS program is safe for managing chronic low back pain?

Research has shown that exercise therapy, a key component of the ENCompaSS program, is generally safe and can help reduce pain in people with chronic low back pain. Studies have found that long-term exercise therapy can relieve pain and improve function in various chronic pain conditions. This treatment is usually well-tolerated and unlikely to cause serious side effects. The program also includes phone calls and educational videos focusing on self-care and support, which are non-invasive and carry very low risk. Overall, evidence supports the safety of the ENCompaSS program for managing chronic low back pain.12345

Why are researchers excited about this trial?

The ENCompaSS program is unique because it combines education, navigated care, and supported self-management into one comprehensive approach for managing chronic low back pain. Unlike standard options that often rely on medication or isolated therapies, ENCompaSS emphasizes structured pain education, shared decision-making, and facilitated access to preferred non-pharmacologic treatments. This holistic method also incorporates asynchronous educational videos and optional SMS communication, aiming to empower patients with tools to manage their pain more effectively. Researchers are excited about this approach because it leverages existing resources while promoting self-efficacy and personalized care, potentially leading to better outcomes for veterans suffering from chronic low back pain.

What evidence suggests that the ENCompaSS program is effective for managing chronic low back pain?

Research has shown that self-management programs can help people with chronic low back pain feel better and move more easily. For instance, one study found that self-management significantly reduced long-term pain. Another study showed that patients using self-management were more likely to reduce their pain by half. In this trial, participants may receive the ENCompaSS program, which includes support from healthcare professionals and has proven effective in previous studies. These programs provide education, decision-making tools, and support for setting personal goals. Overall, evidence suggests that ENCompaSS could be helpful in managing chronic low back pain.678910

Who Is on the Research Team?

SH

Susan Hastings, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for Veterans with chronic low back pain that significantly affects their daily life. Participants should be adults able to take part in phone calls and online activities. People who can't participate in these ways or have other major health issues may not be eligible.

Inclusion Criteria

Ability to provide informed consent
Be enrolled in a participating primary care clinic
Valid telephone access
See 3 more

Exclusion Criteria

Currently hospitalized or residing in a nursing home
I have trouble thinking clearly or making decisions for myself.
Have a serious mental illness (e.g., schizophrenia, bipolar disorder, recent psychiatric hospitalization, high risk suicide flag)
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the ENCompaSS group receive at least three phone calls with a trained clinician over about 12 weeks, watch online videos, and complete surveys

12 weeks
At least 3 phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment, with surveys completed at 2, 4, 6, and 12 months

12 months
Surveys at 2, 4, 6, and 12 months

Long-term follow-up

Additional follow-up to evaluate longer-term effects 12 months post randomization

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • ENCompaSS (Education, Navigated Care, and Supported Self-Management) pain care program

Trial Overview

The study compares a new program called ENCompaSS—which includes educational videos, regular phone support from clinicians, and self-management tools—plus usual care, against usual care alone. Participants are randomly assigned to one of the two groups.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: ENCompaSS + VA Usual Stepped CareActive Control1 Intervention
Group II: VA Usual Stepped CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

Durham VA Medical Center

Collaborator

Trials
40
Recruited
9,300+

Indiana University

Collaborator

Trials
1,063
Recruited
1,182,000+

University of Arizona

Collaborator

Trials
545
Recruited
161,000+

Dallas VA Medical Center

Collaborator

Trials
35
Recruited
4,800+

Citations

Predictors of self-management in patients with chronic low ...

SM programmes generate small to moderate benefits for reducing pain and disability in patients with CLBP.

Nurse-led web-based self-management program to improve ...

Mean (SD) worst back pain for enrolled participants was 7.3 (1.6), and pain-related disability on the Oswestry Disability Index was moderate (42 ...

Supported Self-Management Reduces Chronic Low Back ...

Clinician-supported biopsychosocial self-management significantly reduces the long-term impact and chronicity of low back pain compared with ...

Mobile App–Supported Self-Management for Chronic Low ...

Studies estimate that between 5%‐15% of people will go on to develop chronic low back pain (CLBP; pain lasting longer than 3 months) [Meucci RD, ...

Supported Self-Management of Back Pain from a ...

Effectiveness of communicative and educative strategies in chronic low back pain patients: a systematic review. Self-management program for ...

Exercise therapy for chronic low back pain - PMC - NIH

exercise treatment was found to have improved pain (MD ‐9.1, 95% CI ‐12.6 to ‐5.6) and functional limitations outcomes. All outcomes Low risk 1. Dropout rate ...

Exercise prescription for improving chronic low back pain ...

the results of this study indicate that an intervention period exceeding 16 weeks is optimal for improving chronic low back pain in adults ( 67 ).

Interventions for the Management of Acute and Chronic ...

Physical therapists can use exercise training interventions, including specific trunk muscle activation, for patients with acute low back pain (LBP).

Exercise and Chronic Low Back Pain

There is a substantial and growing body of evidence that long-term exercise therapy can provide pain relief across many different chronic pain conditions, ...

Low Back Pain

Patients with chronic LBP may benefit from exercise, paracetamol or NSAIDs, manual therapy, acupuncture, and multimodal treatment (PT and ...