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

NCT06236529 | Completed

• 1 other identifier: IRB00313911
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Keywords

Self-management; Nurse-led; Web-based

Outcome Measures

Primary Outcomes (2)

• Acceptability of research

  Acceptability - at least 50% of individuals approached agree to eligibility screening for the study, having at least 30% of those who were deemed eligible for the study agree to participate

  Baseline

• Feasibility of study

  Feasibility - (1) having at least 80% of enrolled participants attend at least 3 of the 6 scheduled self-management program sessions; and (2) having a loss to follow-up rate of \< 20% of enrolled participants over the 26-week study

  Baseline

Secondary Outcomes (2)

• Patient Activation Measure (PAM) score

  12 weeks

• Oswestry Disability Index (ODI) score

  12 weeks

Study Arms (3)

Control

NO INTERVENTION

Participants receive no intervention.

Self-management program (SMP)

ACTIVE COMPARATOR

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

Behavioral: Self-management program

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

EXPERIMENTAL

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.

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

Interventions

Health Behavior Change Counseling BEHAVIORAL

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

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• 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.

  PMID: 39085831 DERIVED

MeSH Terms

Conditions

Patient Participation

Interventions

Self-Management

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Richard L Skolasky

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessors were masked to treatment assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 1, 2024
• Study Start: July 16, 2022
• Primary Completion: April 11, 2023
• Study Completion: April 11, 2023
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)