Integrative Mindfulness-Based Predictive Approach for Chronic Low Back Pain Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mindfulness meditation, Perspectives on pain, Discussion.
- Who it may be relevant to
- Registry conditions: Chronic Low-back Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral Mindfulness meditation
Ordinary activities like breathing, eating, and walking are turned into a meditation by creating greater awareness of the moment-to-moment sensations, emotions, thoughts and behaviors that arise during these activities. - Other Perspectives on pain
Understanding pain from a mind-body perspective and viewing pain as a stressor on physical sensations, thoughts, emotions, and behavior. - Other Discussion
Discussion on patients' use of mindfulness to work with pain and pain-themed meditations.
Primary outcome measures
- Pain, Enjoyment, General activity (PEG) composite score [Time frame: 6 months]
Secondary outcome measures (11)
- Depression assessed by the eight-item Patient Health Questionnaire for Depression (PHQ-8) [Time frame: baseline, 4 weeks, 8 weeks, 4 months, 6 months]
- Anxiety assessed by the Generalized Anxiety Disorder-7 (GAD-7) [Time frame: baseline, 4 weeks, 8 weeks, 4 months, 6 months]
- Pain Self-Efficacy assessed by the Pain Self-Efficacy Questionnaire [Time frame: baseline, 4 weeks, 8 weeks, 4 months, 6 months]
- Catastrophizing assessed by the Pain Catastrophizing Scale Short Form [Time frame: baseline, 4 weeks, 8 weeks, 4 months, 6 months]
- Quality of Life assessed by the Patient Reported Outcomes Measurement Information System (PROMIS 29) [Time frame: baseline, 4 weeks, 8 weeks, 4 months, 6 months]
- Participants' Impression of change [Time frame: baseline, 4 weeks, 8 weeks, 4 months, 6 months]
- Mindfulness assessed by the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) [Time frame: baseline, 4 weeks, 8 weeks, 4 months, 6 months]
- Sleep disturbance assessed by the PROMIS Sleep Disturbance-Short Form 6a [Time frame: baseline, 4 weeks, 8 weeks, 4 months, 6 months]
- Pain-Sleep Duration [Time frame: baseline, 4 weeks, 8 weeks, 4 months, 6 months]
- Treatment components and effects assessed by the Healing Encounters and Attitudes List-Expectation [Time frame: baseline, 4 weeks, 8 weeks, 4 months, 6 months]
- Social support assessed by the Social Network Index [Time frame: baseline, 4 weeks, 8 weeks, 4 months, 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Boston Medical Center — Boston
Identifiers
NCT: NCT06106191 · H-44407 · UG3NS135168