Health TrialsbyHealthPanel

Integrative Mindfulness-Based Predictive Approach for Chronic Low Back Pain Treatment

ConditionChronic Low-back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Mindfulness meditation

    Behavioral

    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.

  • Perspectives on pain

    Other intervention

    Understanding pain from a mind-body perspective and viewing pain as a stressor on physical sensations, thoughts, emotions, and behavior.

  • Discussion

    Other intervention

    Discussion on patients' use of mindfulness to work with pain and pain-themed meditations.

Treatment groups

350 Participants
are divided into 1 treatment group
Group A: Mindfulness based stress reduction (MBSR) programExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Pain, Enjoyment, General activity (PEG) composite score

The PEG is a 3-question scale: "pain average", "interference with general activity" and "interference with enjoyment of life". Each question is on a 0-10 scale, and total PEG is the average. Scores can range from 0-30 and \<12=Mild,12 to \<21 = Moderate, 21 to 30 = Severe chronic pain.

Time frame
6 months

Secondary outcomes

1

Depression assessed by the eight-item Patient Health Questionnaire for Depression (PHQ-8)

The total score is determined by adding together the scores of each of the four items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). Total score ≥3 for first 2 questions suggests anxiety. Total score ≥3 for last 2 questions suggests depression.

Time frame
baseline, 4 weeks, 8 weeks, 4 months, 6 months
2

Anxiety assessed by the Generalized Anxiety Disorder-7 (GAD-7)

This is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." GAD-7 total score for the seven items ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.

Time frame
baseline, 4 weeks, 8 weeks, 4 months, 6 months
3

Pain Self-Efficacy assessed by the Pain Self-Efficacy Questionnaire

The PSEQ is a 10-question survey that measures the confidence of a person with persistent pain to do a range of activities while in pain. The total score ranges from 0 to 60. High PSEQ scores are strongly associated with clinically- significant functional levels and provide a useful gauge for evaluating outcomes in chronic pain patients. Higher scores (and a higher percentile) represent higher confidence to function with pain.

Time frame
baseline, 4 weeks, 8 weeks, 4 months, 6 months
4

Catastrophizing assessed by the Pain Catastrophizing Scale Short Form

The Pain Catastrophizing Scale (PCS) measures three aspects of catastrophic cognitions about pain-rumination, magnification, and helplessness. It consists of 13 items scored from 0 to 4, with a total range of 0 to 52. Higher scores are less favorable and a score of more than 30 points may indicate clinical relevance.

Time frame
baseline, 4 weeks, 8 weeks, 4 months, 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston Medical Center

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Worcester Polytechnic Institute

Collaborator

Source ClinicalTrials.gov
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