Study Summary
This trial will investigate whether mindfulness, or listening to a book, can change brain activity in response to pain.
Eligible Conditions
- Chronic Lower Back Pain
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 22 Secondary · Reporting Duration: All 12 intervention sessions, MRI 2, and MRI 3 (Visit 3-16). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
Week 8
Perceived Intervention Effectiveness
Week 8
Mental Depression
Brief Pain Inventory
Chronic Pain Acceptance Questionnaire
Cohen Perceived Stress Scale
Five Facet Mindfulness Questionnaire
Mindfulness
PROMIS 29-Item Profile
PROMIS Pain Behavior Measure
Pain
Pain Catastrophizing Scale
Pain Self Efficacy Questionnaire
Patients' Global Impression of Change
Pittsburgh Sleep Quality Index
Positive and Negative Affect Scale
Profile of Mood States Form
Roland-Morris Disability Questionnaire
SF 12 Health Survey
Social Connectedness Scale
Visual Analog Scale Pain Ratings
Week 8
State Anxiety Inventory
Week 8
Respiration Rate
Week 8
Cerebral Blood Flow (average blood perfusion; mL blood/100 grams tissue/minute)
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
Book Listening Control Group
1 of 3
Meditatin Group
1 of 3
Meditation Group
1 of 3
Active Control
Experimental Treatment
120 Total Participants · 3 Treatment Groups
Primary Treatment: Meditation training · No Placebo Group · N/A
Meditation Group
Behavioral
Experimental Group · 1 Intervention: Meditation training · Intervention Types: BehavioralBook Listening Control Group
Behavioral
ActiveComparator Group · 1 Intervention: Book Listening Control · Intervention Types: BehavioralMeditatin Group
Behavioral
ActiveComparator Group · 1 Intervention: Meditatin training · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: all 12 intervention sessions, mri 2, and mri 3 (visit 3-16). active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,037 Previous Clinical Trials
1,825,462 Total Patients Enrolled
Fadel Zeidan, PhDPrincipal Investigator - Principal Investigator
University of California, San Diego
5 Previous Clinical Trials
159 Total Patients Enrolled
Eligibility Criteria
Age 18 - 65 · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have never practiced meditation before.
Your nerve pain must have lasted for at least 3 months.
Who else is applying?
What state do they live in?
| California | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| UC San Diego Center for Mindfulness | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
References
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- Fadel Zeidan 2020. "Mindfulness and Chronic Low Back Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03354585.
Frequently Asked Questions
Are there vacancies available for individuals to partake in this study?
"Clinicaltrials.gov confirms that, as of April 5th 2022, this study is actively searching for trial participants. It was initially listed on the website in February 2020." - Anonymous Online Contributor
Unverified Answer
Does the trial's age criterion include participants over 25?
"This clinical trial is exclusively for individuals aged 18-65. Those younger than 18 can look into the 11 trials available to them, while adults over 65 have access to 264 studies." - Anonymous Online Contributor
Unverified Answer
What is the maximum number of participants permitted in this experiment?
"Indeed, the clinicaltrials.gov database states that this research is actively seeking to enroll participants. It was initially posted on February 1st 2020 and has been recently updated as of May 4th 2022. This trial needs 120 patients from 3 medical institutions for completion." - Anonymous Online Contributor
Unverified Answer
What criteria must potential participants meet to join this investigation?
"This medical trial is inviting 120 individuals aged 18-65 who have had low back pain for at least three months. Applicants must also report a 3 or greater on the 0-10 visual analog scale, lack prior meditative experience and be right handed to qualify for participation." - Anonymous Online Contributor
Unverified Answer