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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low-back Pain; Patient Activation
• Intervention / Treatment: Behavioral: Self-management program; Behavioral: Health Behavior Change Counseling

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Participants receive no intervention.
Active Comparator: Self-management program (SMP); Participants engage in a nurse-led evidence-based web-enabled group self-management class for 6 weeks.	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.
Experimental: 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.	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.; Behavioral: Health Behavior Change Counseling; A telephone-based intervention employing principles and practices of motivational interviewing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Activation Measure (PAM) score	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)	12 weeks
Oswestry Disability Index (ODI) score	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.	12 weeks

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Richard L Skolasky, Johns Hopkins School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2022
• Primary Completion (Actual): April 11, 2023
• Study Completion (Actual): April 11, 2023

Study Registration Dates

• First Submitted: January 24, 2024
• First Submitted That Met QC Criteria: January 24, 2024
• First Posted (Actual): February 1, 2024

Study Record Updates

• Last Update Posted (Actual): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Self-management; Nurse-led; Web-based
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: IRB00313911

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No