Self-Management of Chronic Low Back Pain: Targeting Patient Activation

Johns Hopkins University

Status: Completed

Conditions: Chronic Low-back Pain; Patient Activation

Treatments: Behavioral: Health Behavior Change Counseling; Behavioral: Self-management program

Study type: Interventional

Funder types: Other

Identifiers

NCT06236529

IRB00313911

Details and patient eligibility

About

Patients with chronic low back (cLBP) pain report reduced physical function and ability to participate in social roles and are more likely to use opioid pain medications. While self-management interventions have been shown to support these patients, effectiveness has been limited due to poor patient engagement. "Patient activation" encompasses the skills, knowledge, and motivation that a person has to manage the person's health. Supporting patient activation may improve the effectiveness of self-management for cLBP.

In this single-masked pilot study of adults with cLBP, patients were randomized to receive either no intervention (control) or 6 weekly sessions of an evidence-based web-based self-management program (SMP) with or without health behavior change counseling (HBCC) using motivational interviewing. Participants were assessed at baseline and at 12 and 26 weeks using the Patient Activation Measure, Oswestry Disability Index and Patient-Reported Outcomes Measurement Information System (PROMIS) physical function, social role participation, and pain interference. The investigators assessed acceptability and feasibility based on recruitment, session attendance, and follow-up.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults (18+ years of age)
• Seen in primary or specialty care practice for non-specific low back pain
• Chronic low back pain per the NIH Task Force on Research Standards for cLBP
• Worst back pain of at least 4/10 points
• Oswestry disability index of at least 24%
• English speaking

Exclusion criteria

• History of lumbar spine decompression/laminectomy or fusion surgery in the past 6 months
• Possible non-musculoskeletal cause for LBP symptoms diagnosis at baseline
• "Red flag" LBP diagnosis in the previous 6 months (e.g., cauda equina syndrome, osteomyelitis, or spinal neoplasm)
• Neurological disorder resulting in moderate to severe movement dysfunction
• Presence of any psychotic disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 3 patient groups

Control

No Intervention group

Description:

Participants receive no intervention.

Self-management program (SMP)

Active Comparator group

Description:

Participants engage in a nurse-led evidence-based web-enabled group self-management class for 6 weeks.

Treatment:

Behavioral: Self-management program

Self-management program (SMP) with Health Behavior Change Counseling (HBCC)

Experimental group

Description:

Participants engage in a nurse-led evidence-based web-enabled group self-management class for 6 weeks and receive three telephone-based health behavioral change counseling sessions based on the principles and practices of motivational interviewing.

Treatment:

Behavioral: Health Behavior Change Counseling

Behavioral: Self-management program