Clinical trial NCT06106191: Integrative Mindfulness-Based Predictive Approach for Chronic Low Back Pain Treatment
Official title: Integrative Mindfulness-Based Predictive Approach for Chronic Low Back Pain Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: Mindfulness based stress reduction (MBSR)
Machine learning (ML)
Biopsychosocial data
PEG (Pain, Enjoyment, General activity)
Pain interference
Pain intensity
Depression
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: Worcester Polytechnic Institute
First posted: 2023-10-30
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will identify unique signatures that people have which can cause pain by evaluating biological, psychological, and social markers using artificial intelligence. These markers can be used to accurately predict the response of diverse individuals with chronic low back pain (cLBP) to Mindfulness-Based Stress Reduction. This will help enhance clinician decision-making and the targeted treatment of chronic pain.

The overall objective is to use a unique machine learning (ML) approach to determine the biomarker signature of persons undergoing mindfulness based stress reduction (MBSR) treatment for their chronic low back pain (cLBP). This signature will facilitate clinical prediction and monitoring of patient response to MBSR treatment.

The design of the study is a single-arm clinical trial of the evidence-based MBSR program for patients with cLBP.

Detailed description: UG3 Phase Overview. The first 24-months of the project will be dedicated to performing machine learning modeling to identify candidate predictive and monitoring markers of cLBP response to MBSR, prior to the full clinical trial in the UH3 phase. We will also refine our procedures such as recruitment and outcomes assessment with 50 persons during the UG3 phase.

UH3 Phase Overview. Biopsychosocial markers will be identified of the response of diverse cLBP patients to MBSR (N=300) from comprehensive pain assessment and biopsychosocial data, including pain intensity and pain interference, physical activity, sleep, and heart rate for a 6-month period. Data will be collected and used for training and testing ML models. The MBSR program is evidence-based and meets weekly in a group via Zoom for 8-weeks for 90 minutes per week. Measures to determine biomarkers will be obtained at baseline (T1), four-weeks (T2), program completion (T3), four months (T4), and six months (T5). The main outcome timepoint with be at six months (T5), which allows time for durability of effects to be determined. The PEG (Pain, Enjoyment, General activity), obtained through online self-report surveys is the main outcome measure. Secondary outcomes of physical and psychological function will be self-report and obtained online, or if the patient prefers, by telephone, and physical activity, sleep, and heart rate variability will be collected by Fitbit.

Eligibility criteria: Inclusion Criteria:

* Chronic low back pain, which is pain that persists for at least 3-months and has resulted in pain on at least half the days in the past 6 months
* Willing and able to provide online or telephone informed consent
* Speak English as the intervention manual is currently written in English

Exclusion Criteria:

* Red flags- recent (past month) worsening of pain, unexplained fever, unexplained weight loss
* Pregnancy
* Metastatic cancer
* Not a patient at a participating clinic or persons not planning to continue as a patient at a participating clinic for 6 or more months

Primary outcomes:
measure: Pain, Enjoyment, General activity (PEG) composite score
timeFrame: 6 months
Secondary outcomes:
measure: Depression assessed by the eight-item Patient Health Questionnaire for Depression (PHQ-8)
timeFrame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
measure: Anxiety assessed by the Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
measure: Pain Self-Efficacy assessed by the Pain Self-Efficacy Questionnaire
timeFrame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
measure: Catastrophizing assessed by the Pain Catastrophizing Scale Short Form
timeFrame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
measure: Quality of Life assessed by the Patient Reported Outcomes Measurement Information System (PROMIS 29)
timeFrame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
measure: Participants' Impression of change
timeFrame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
measure: Mindfulness assessed by the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
timeFrame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
measure: Sleep disturbance assessed by the PROMIS Sleep Disturbance-Short Form 6a
timeFrame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
measure: Pain-Sleep Duration
timeFrame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
measure: Treatment components and effects assessed by the Healing Encounters and Attitudes List-Expectation
timeFrame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
measure: Social support assessed by the Social Network Index
timeFrame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Natalia Morone, MD MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Worcester Polytechnic Institute
name: Jean King, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Worcester Polytechnic Institute
name: Emmanuel Agu, PhD
role: PRINCIPAL_INVESTIGATOR
References: