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

Chronic Low-back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06236529
• Other study ID #: IRB00313911
• Status: Completed
• Phase: N/A
• Start date: July 16, 2022
• Est. completion date: April 11, 2023

Study information

• Verified date: January 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 11, 2023
• Est. primary completion date: April 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain
• Patient Activation

Intervention

Behavioral:
• Health Behavior Change Counseling
A telephone-based intervention employing principles and practices of motivational interviewing.
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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