Clinical trial NCT06236529: Self-Management of Chronic Low Back Pain: Targeting Patient Activation
Official title: Supporting Patient Activation for Self-Management of Chronic Low Back Pain With a Targeted Intervention Based on Key Influencing Characteristics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Patient Activation
Keywords: Self-management
Nurse-led
Web-based
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Acceptability of research
timeFrame: Baseline
measure: Feasibility of study
timeFrame: Baseline
Secondary outcomes:
measure: Patient Activation Measure (PAM) score
timeFrame: 12 weeks
measure: Oswestry Disability Index (ODI) score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Richard L Skolasky
role: PRINCIPAL_INVESTIGATOR
References: