Mindfulness and Chronic Low Back Pain

  • STATUS
    Recruiting
  • End date
    Oct 2, 2024
  • participants needed
    120
  • sponsor
    University of California, San Diego
Updated on 24 April 2022
chronic pain
low back pain
radicular pain

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.

Description

You have been asked to participate in this study because you are interested in learning mindfulness and have been diagnosed with chronic low-back pain. Your participation is voluntary. We will randomly assign 40 subjects to each group for the initiation of the final phase of the study. Randomization means that you have a one in two chance of being assigned to the mindfulness meditation training or book-listening control intervention. Your assignment is based on chance rather than a medical decision made by the researchers.

Details
Condition Chronic Low Back Pain
Treatment Mindfulness Training, Meditation training, Book Listening Control, Meditatin training
Clinical Study IdentifierNCT03354585
SponsorUniversity of California, San Diego
Last Modified on24 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note