Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06236529
Other study ID # IRB00313911
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT05963451 - Brain, Psychological and Epigenetic Determinants for Optimizing the Treatment of Chronic Low Back Pain
Completed NCT04283370 - A Study Protocol Comparing a Home Rehabilitation Program Versus e-Health Program in Low Back Pain N/A
Completed NCT04824547 - Evaluation of Long-Term Continuity of Exercises in Low Back Pain Individuals N/A
Completed NCT04046419 - In Turkish Version "Health Care Providers and Impairment Relationship Scale (HC-PAIRS)"
Completed NCT04399772 - COgNitive FuncTional Therapy+ for Chronic Low Back paIn N/A
Recruiting NCT05780021 - Motivational Support Program in Chronic Low Back Pain After Multidisciplinary Functional Rehabilitation N/A
Completed NCT04555278 - Combining Non-invasive Brain Stimulation and Exercise to Treat Low Back Pain N/A
Completed NCT04530071 - Evaluation of Safety, Tolerability, and Efficacy of CordSTEM-DD in Patients With Chronic Low Back Pain Phase 1/Phase 2
Not yet recruiting NCT06347328 - The Benefits of Posterior Joint Infiltration in Chronic Low Back Pain N/A
Not yet recruiting NCT04940715 - Efficacy of Passive Joint Mobilization vs Mobilization With Movement on Pain Processing in Patients With Chronic Low Back Pain N/A
Recruiting NCT04683718 - A First in Human Feasibility Study to Evaluate the Safety and Effectiveness of the BIOTRONIK Prospera SCS System With HomeStream Remote Management N/A
Recruiting NCT05724160 - Using Non-Weightbearing Stationary Elliptical Machines for Patients With Chronic Low Back Pain N/A
Recruiting NCT06030128 - Core Stabilization Exercise Therapy in Chronic Lower Back Back Management in Community Dwelling Older Adults N/A
Recruiting NCT05846087 - Mobile App-delivered Sleep Therapy (SleepFix) for Individuals With Chronic Low Back Pain and Insomnia N/A
Active, not recruiting NCT05396014 - The BEST Trial: Biomarkers for Evaluating Spine Treatments Phase 4
Active, not recruiting NCT06140862 - Ankle Spine Syndrome "RAFFET Syndrome II N/A
Completed NCT05512338 - Motivation and Adherence to Exercise Recommendations N/A
Recruiting NCT05021146 - Essential Oil for Chronic Low Back Pain N/A
Completed NCT05120921 - Osteopathic Single CAse Research for Patients With Chronic Low Back Pain N/A
Completed NCT05690178 - Deep Tissue Massage in Office Workers With Chronic Low Back Pain N/A