Mindfulness and Chronic Low Back Pain

NCT03354585 | Completed DMC

• 1 other identifier: 181814
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to see if mindfulness, a form of mental training, or listening to a book alters brain activation in response to raising your leg that may produce the feeling of pain. A technique called functional magnetic resonance imaging (fMRI) allows scientists to determine which parts of the brain are active during a particular task. This study will provide new information about how mindfulness affects the brain.

Conditions

Chronic Low Back Pain

Keywords

Mindfulness; fMRI; Pain; Low Back; Radicular

Outcome Measures

Primary Outcomes (1)

• Cerebral Blood Flow (average blood perfusion; mL blood/100 grams tissue/minute)

  Changes in cerebral blood flow will be assessed during pseudo continuous arterial spin labeling fMRI during their respective manipulations.

  There will be up to 2 fMRI sessions (Visit 2, and 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.

Secondary Outcomes (12)

• Visual Analog Scale Pain Ratings

  Baseline and 3 fMRI sessions (Visit 1, 2, 9, and 16). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.

• Numerical Pain Ratings

  Two fMRI sessions. Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.

• Blood Oxygen Dependent Signaling

  Two fMRI sessions. Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.

• Respiration Rate

  There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.

• Five Facet Mindfulness Questionnaire

  There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.

Other Outcomes (12)

• Social Connectedness Scale

  There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.

• Perceived Intervention Effectiveness

  There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.

• Positive and Negative Affect Scale

  There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.

Study Arms (3)

mindfulness group

EXPERIMENTAL

Study volunteers will participate in a six-session meditation training regimen. In brief, subjects will be taught that perceived sensory events are "momentary" and "fleeting" and do not require further evaluation. There will be an emphasis on breath focus and altering one's perspective of discursive sensory events. This intervention has been found to reliably attenuate the subjective experience of pain.

Behavioral: mindfulness training

non-mindfulness group

SHAM COMPARATOR

Study volunteers will participate in a six-session meditation training regimen. In brief, subjects will be taught to take deep breaths and relax.

Behavioral: non-mindfulness training

book-listening

ACTIVE COMPARATOR

Study volunteers will listen to an audio recording of the Natural History of Selborne across each session.This 6 session intervention is meant to provide the control attention to the facilitator, room setting, social support, conditioning, and the time elapsed during the other respective interventions. We do not expect that this group will demonstrate significant cerebral blood flow changes as a function of the intervention.

Behavioral: book-listening

Interventions

mindfulness training BEHAVIORAL

A well-validated brief mindfulness-based mental training regimen \[20 min/session(s)\] will be used to teach patients to independently practice mindfulness. Participants will be asked to close their eyes acknowledge distracting thoughts and feelings.

Also known as: mental training

mindfulness group

non-mindfulness training BEHAVIORAL

A well-validated brief meditation-based mental training regimen \[20 min/session(s)\] will be used to teach patients to independently practice deep breathing. Participants will be asked to close their eyes acknowledge distracting thoughts and feelings.

Also known as: mental training

non-mindfulness group

book-listening BEHAVIORAL

Study volunteers will listen to The Natural History and Antiquities of Selborne throughout the intervention.

book-listening

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have a medical evaluation that demonstrates chronic low back pain that is evoked by lifting the legs. Existing medical records, per physician discretion and low back examinations will confirm diagnosis. This will be determined over the phone during the (pre) screening and at study session 1, and will not be contingent on MRI.
• Participants must be between the ages of 18-65 years.
• Participants must rate their daily chronic pain intensity at a 3 or greater on 0-10 visual analog scale.
• Participants must have experienced their radicular pain for at least 3 months duration.
• Participants must be right-handed.
• Participants must have no prior meditative experience

You may not qualify if:

• Participants must not be participating in any new (within 2 weeks prior or anytime after enrollment) pain management procedures during the study period.
• Participants must not have had back surgery within the last year before their enrollment into the study.
• Participants must not have had any other sensory or motor deficits that precludes participation in this study.
• Participants must not have known anomalies of the central nervous system including: stroke, dementia, aneurysm, a personal history of psychosis.
• Participants must not have metal implants including ferrous arterial stints or coils, spinal stimulators, pacemakers, or defibrillators, permanently implanted hearing aides, bullets, BBs, or pellets, retinal eye implants, infusion pump for insulin or other medicines, ferrous surgical clips, staples, metal sutures, orthopedic hardware above or including the shoulders, body piercings that cannot be removed.
• Participants must not be claustrophobic.
• Participants must not produce negative straight leg test (i.e. a test is considered positive when the person reports reproducible pain at 40 degrees of hip flexion or less).
• Participants must not be pregnant
• Participants must not be over 275 pounds

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (2)

UC San Diego

La Jolla, California, 92037, United States

Location

UC San Diego Center for Functional MRI

La Jolla, California, 92093, United States

Location

Related Publications (32)

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MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fadel Zeidan, PhD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the study physician, research coordinator, and intervention facilitators will be aware of group assignment.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This intervention study will utilize an unbiased randomized study design. Pain intensity and pain unpleasantness ratings will be assessed using before and after all sessions where low back pain is induced. Study volunteers will be randomized and subsequently participate in a six session mindfulness meditation, non-mindfulness meditation or book-listening control regimen. Study volunteers will be required to complete two MRI scans over the course of the study.

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: November 28, 2017
• Study Start: January 2, 2020
• Primary Completion: February 5, 2024
• Study Completion: February 5, 2024
• Last Updated: April 29, 2024

Record last verified: 2024-04

Locations

US (2)