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Completed

NCT Number: NCT06236529

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

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.

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Key information

Conditions

Chronic Low-back Pain Behavior Health Behavior Patient Acceptance of Health Care Patient Activation Patient Participation Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Health Behavior Change Counseling

Behavioral

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

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.

Primary outcomes

  1. Acceptability of research

    Time frame: Baseline

    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

  2. Feasibility of study

    Time frame: Baseline

    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

Secondary outcomes

  1. Patient Activation Measure (PAM) score

    Time frame: 12 weeks

    The Patient Activation Measure (PAM) is a 13-item instrument where patients are provided 5 response options, ranging from "strongly agree" to "strongly disagree." Based on their answers, patients were assigned a numerical score ranging from 0 (no activation) to 100 (highest activation), and the score was used to stratify patients into 1 of 4 stages of activation: stage 1 (believes taking an active role is important), stage 2 (has the confidence and knowledge to take action), stage 3 (takes action), and stage 4 (stays the course under stress)

  2. Oswestry Disability Index (ODI) score

    Time frame: 12 weeks

    Pain-related disability was assessed using the ODI, a 10-item measure of low back pain-related disability that evaluates the current effect of a patient's low back pain on various aspects of daily living. ODI scores range from 0 to 100, with higher scores indicating greater disability.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

Supporting Patient Activation for Self-Management of Chronic Low Back Pain With a Targeted Intervention Based on Key Influencing Characteristics

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 1, 2024
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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