Supporting Patient Activation for Self-Management of Chronic Low Back Pain With a Targeted Intervention Based on Key Influencing Characteristics
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Low-back Pain
- Sponsor
- Johns Hopkins University
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Acceptability of research
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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
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
- Oswestry Disability Index (ODI) score(12 weeks)
- Patient Activation Measure (PAM) score(12 weeks)