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

NCT ID: NCT06236529

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-16
• Study Completion Date: 2023-04-11

Brief Summary

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.

Conditions

Chronic Low-back Pain; Patient Activation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

Participants receive no intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Self-management program (SMP)

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

Group Type: ACTIVE_COMPARATOR

Self-management program

Intervention Type: BEHAVIORAL

An evidence-based 6-week SMP led by a registered nurse. The SMP was based on the Arthritis Self-Management Program and the Chronic Disease Self-Management Program.

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

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.

Group Type: EXPERIMENTAL

Health Behavior Change Counseling

Intervention Type: BEHAVIORAL

A telephone-based intervention employing principles and practices of motivational interviewing.

Self-management program

Intervention Type: BEHAVIORAL

An evidence-based 6-week SMP led by a registered nurse. The SMP was based on the Arthritis Self-Management Program and the Chronic Disease Self-Management Program.

Interventions

Health Behavior Change Counseling

A telephone-based intervention employing principles and practices of motivational interviewing.

Intervention Type: BEHAVIORAL

Self-management program

An evidence-based 6-week SMP led by a registered nurse. The SMP was based on the Arthritis Self-Management Program and the Chronic Disease Self-Management Program.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard L Skolasky

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Countries

United States

References

Skolasky RL, Nolan S, Pierre R, Vinch P, Taylor JL. Nurse-led web-based self-management program to improve patient activation and health outcomes in patients with chronic low back pain: an acceptability and feasibility pilot study. BMC Nurs. 2024 Jul 31;23(1):524. doi: 10.1186/s12912-024-02155-w.

Reference Type: DERIVED

PMID: 39085831 (View on PubMed)

Other Identifiers

IRB00313911

Identifier Type: -

Identifier Source: org_study_id