Chronic Low Back PainNCT03354585

Mindfulness and Chronic Low Back Pain

A study testing mindfulness training, non-mindfulness training and book-listening in people with Chronic Low Back Pain, run by University of California, San Diego at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Chronic Low Back Pain
What is being tested?: mindfulness training, non-mindfulness training and book-listening
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 2 sitesUnited States
Study dates: 2 Jan 2020to 5 Feb 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Show all 9Show fewer

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

UC San Diego
La Jolla, California, 92037
UC San Diego Center for Functional MRI
La Jolla, California, 92093

Other trials in United States

About this study

Official title: Brain Mechanisms Supporting Mindfulness-based Chronic Pain Relief

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.

Read the detailed description

To determine if mindfulness meditation-induced reductions in chronic low back pain (cLBP) patients will be associated with greater anterior insula (aINS), orbitofrontal cortex (OFC), subgenual anterior cingulate cortex (sgACC), and/or thalamic deactivation when compared to rest, the sham-mindfulness meditation and the book-listening control groups. One-hundred and twenty individuals will be randomized to a mindfulness meditation (n=40), non-mindfulness meditation (n=40) and book-listening-control (n=40). Each participants will be administered noxious heat and the chronic low back pain evoking, straight leg raise test during fMRI.

Conditions: Chronic Low Back Pain
Being tested: mindfulness training, non-mindfulness training, book-listening
Keywords: Mindfulness, fMRI, Pain, Low Back, Radicular
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

mindfulness trainingBehavioural
Also called mental training
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.
non-mindfulness trainingBehavioural
Also called mental training
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.
book-listeningBehavioural
Study volunteers will listen to The Natural History and Antiquities of Selborne throughout the intervention.

Study groups in NCT03354585
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Behavioral: book-listening

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Changes in visual analog scale (VAS) pain ratings will be assessed in response to the straight leg raise test and lying supine in the MRI scanner.
Psychophysical Assessment of Pain: As previously in all of our previous pain studies, pain intensity and unpleasantness ratings will be assessed with a Visual Analog Scale. These scales 1) provide reliably separate assessment of experimental and clinical pain intensity and unpleasantness, 2) are internally consistent, and 3) approximate ratio scale measurement accuracy. The minimum rating ("0") is designated as "no pain" whereas the maximum ("10") is labeled as "most intense imaginable" or "most unpleasant imaginable".
Higher numbers correspond to higher perceived pain
Measured: 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
Changes in numerical pain ratings (NRS) will be assessed in response to the straight leg raise test and lying supine in the MRI scanner.
Psychophysical Assessment of Pain: As previously in all of our previous pain studies, pain intensity and unpleasantness ratings will be assessed with a Visual Analog Scale. These scales 1) provide reliably separate assessment of experimental and clinical pain intensity and unpleasantness, 2) are internally consistent, and 3) approximate ratio scale measurement accuracy. The minimum rating ("0") is designated as "no pain" whereas the maximum ("10") is labeled as "most intense imaginable" or "most unpleasant imaginable".
Higher numbers correspond to higher perceived pain
Measured: Two fMRI sessions. Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
Blood Oxygen Dependent Signaling
Changes in BOLD fMRIacquired during noxious heat stimulation during rest and manipulations Psychophysical Assessment of Pain: As previously in all of our previous pain studies, pain intensity and unpleasantness ratings will be assessed with a Visual Analog Scale. These scales 1) provide reliably separate assessment of experimental and clinical pain intensity and unpleasantness, 2) are internally consistent, and 3) approximate ratio scale measurement accuracy. The minimum rating ("0") is designated as "no pain" whereas the maximum ("10") is labeled as "most intense imaginable" or "most unpleasant imaginable".
Higher numbers correspond to higher perceived pain
Measured: Two fMRI sessions. Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
Respiration Rate
Respiration rate will be collected and recorded on a Biopac respiratory transducer. Changes in respiration rate could be predictive of analgesia and health promotion.
Measured: 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
This is a 39-item multidimensional measure of trait mindfulness and includes five subscales: non-reactivity, nonjudgment, describing, observing, and acting with awareness. A numeric value between 1 (never or very rarely true) and 5 (very often or always true) is provided in response to each statement.
Measured: 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.
PROMIS Pain Behavior Measure
This is a 5-item questionnaire that measures complaints of suffering, verbal or nonverbal (i.e. such as when I am in pain I squirm) from the past 7 days. Scoring for this measure is item-content dependent.
Measured: 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.
Brief Pain Inventory
This is an 8-item assessment widely used to measure clinical pain. Higher scores reflect a higher severity rating of pain.
Measured: 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.
Pain Catastrophizing Scale
This is a 13-item questionnaire with 3 subscales assessing rumination, magnification, and helplessness in patients. A numeric value between 0 (not at all) and 4 (all the time) is provided in response to each statement. Scores on this assessment range from 0 to 52, with higher values reflecting more salient impacts of pain on one's day to day experience.
Measured: 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.
Beck Depression Inventory
This is a 21-item standard assessment used to measure clinical depression. Scores on this assessment range from 0 to 63, where higher scores indicate higher levels of depression.
Measured: 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.
Freiburg Mindfulness Inventory
This is a 14-item standard mindfulness scale to measure potential changes in mindfulness before and after intervention. A rating between "rarely" (0) to "often" (4) is provided in response to each statement.
Measured: 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.
Roland-Morris Disability Questionnaire
This is a critical assessment for assessing the functional impact of chronic low back pain. Scores on this assessment range from 0 to 24, where higher scores indicate greater disability and limited functioning due to pain.
Measured: 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.
Cohen Perceived Stress Scale
The CPS is a series of 10 temporally constrained (i.e. in the last month) questions meant to ascertain the relative frequency of stressors in one's life, ranging from never (scored as 0) to very often (scored as 4). All positively stated questions are reversed scored and then all items are summed to yield a final estimate of stress. The higher the score the higher the level of stress.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jan 20205 Feb 2024

First posted28 Nov 2017
Study start2 Jan 2020
Primary completion5 Feb 2024
Study completion5 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (34)Papers the sponsor has linked to this study.
Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03354585
Sponsor's protocol ID: 181814
Status last verified: Apr 2024
First submitted: 16 Oct 2017
Last updated: 29 Apr 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Apkarian AV, Krauss BR, Fredrickson BE, Szeverenyi NM. Imaging the pain of low back pain: functional magnetic resonance imaging in combination with monitoring subjective pain perception allows the study of clinical pain states. Neurosci Lett. 2001 Feb 16;299(1-2):57-60. doi: 10.1016/s0304-3940(01)01504-x.
PubMed 11166937
Bruno PA, Millar DP, Goertzen DA. Inter-rater agreement, sensitivity, and specificity of the prone hip extension test and active straight leg raise test. Chiropr Man Therap. 2014 Jun 16;22:23. doi: 10.1186/2045-709X-22-23. eCollection 2014.
PubMed 24982755
Chen X, Spaeth RB, Freeman SG, Scarborough DM, Hashmi JA, Wey HY, Egorova N, Vangel M, Mao J, Wasan AD, Edwards RR, Gollub RL, Kong J. The modulation effect of longitudinal acupuncture on resting state functional connectivity in knee osteoarthritis patients. Mol Pain. 2015 Oct 29;11:67. doi: 10.1186/s12990-015-0071-9.
PubMed 26511911
Cropley M, Ussher M, Charitou E. Acute effects of a guided relaxation routine (body scan) on tobacco withdrawal symptoms and cravings in abstinent smokers. Addiction. 2007 Jun;102(6):989-93. doi: 10.1111/j.1360-0443.2007.01832.x.
PubMed 17523994
Eisenach JC, Rauck RL, Curry R. Intrathecal, but not intravenous adenosine reduces allodynia in patients with neuropathic pain. Pain. 2003 Sep;105(1-2):65-70. doi: 10.1016/s0304-3959(03)00158-1.
PubMed 14499421
Eisenach JC, Thomas JA, Rauck RL, Curry R, Li X. Cystatin C in cerebrospinal fluid is not a diagnostic test for pain in humans. Pain. 2004 Feb;107(3):207-212. doi: 10.1016/j.pain.2003.09.007.
PubMed 14736582
Fardon DF. Nomenclature and classification of lumbar disc pathology. Spine (Phila Pa 1976). 2001 Mar 1;26(5):461-2. doi: 10.1097/00007632-200103010-00007. No abstract available.
PubMed 11242371
Fardon DF, Williams AL, Dohring EJ, Murtagh FR, Gabriel Rothman SL, Sze GK. Lumbar disc nomenclature: version 2.0: Recommendations of the combined task forces of the North American Spine Society, the American Society of Spine Radiology and the American Society of Neuroradiology. Spine J. 2014 Nov 1;14(11):2525-45. doi: 10.1016/j.spinee.2014.04.022. Epub 2014 Apr 24.
PubMed 24768732
Jamison RN, Ross EL, Michna E, Chen LQ, Holcomb C, Wasan AD. Substance misuse treatment for high-risk chronic pain patients on opioid therapy: a randomized trial. Pain. 2010 Sep;150(3):390-400. doi: 10.1016/j.pain.2010.02.033. Epub 2010 Mar 23.
PubMed 20334973
Kwong EH, Virani N, Robert M, Gerry K, Harding A, Rose MS, Dukelow SP, Barton PM. Inter-rater reliability of the Active Straight-Leg Raise and One-Leg Standing tests in non-pregnant women. J Rehabil Med. 2013 Nov;45(10):1058-64. doi: 10.2340/16501977-1213.
PubMed 23995959
Lazar N (2008) The Statistical Analysis of Functional MRI Data. New York, New York: Springer.
Loggia ML, Kim J, Gollub RL, Vangel MG, Kirsch I, Kong J, Wasan AD, Napadow V. Default mode network connectivity encodes clinical pain: an arterial spin labeling study. Pain. 2013 Jan;154(1):24-33. doi: 10.1016/j.pain.2012.07.029. Epub 2012 Oct 27.
PubMed 23111164
Mens JM, Vleeming A, Snijders CJ, Stam HJ, Ginai AZ. The active straight leg raising test and mobility of the pelvic joints. Eur Spine J. 1999;8(6):468-73. doi: 10.1007/s005860050206.
PubMed 10664304
Pantano P, Mainero C, Lenzi D, Caramia F, Iannetti GD, Piattella MC, Pestalozza I, Di Legge S, Bozzao L, Pozzilli C. A longitudinal fMRI study on motor activity in patients with multiple sclerosis. Brain. 2005 Sep;128(Pt 9):2146-53. doi: 10.1093/brain/awh549. Epub 2005 May 18.
PubMed 15901646
Quiton RL, Keaser ML, Zhuo J, Gullapalli RP, Greenspan JD. Intersession reliability of fMRI activation for heat pain and motor tasks. Neuroimage Clin. 2014 Jul 22;5:309-21. doi: 10.1016/j.nicl.2014.07.005. eCollection 2014.
PubMed 25161897

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Chronic Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Brain Mechanisms Supporting Mindfulness-based Chronic Pain Relief
ClinicalTrials.gov ID: NCT03354585
Acronym / sponsor ID: 181814
Conditions: Chronic Low Back Pain
Keywords: Mindfulness, fMRI, Pain, Low Back, Radicular
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: University of California, San DiegoUniversity, hospital or other
Study start: 2 Jan 2020 (actual)
Primary completion: 5 Feb 2024 (actual)
Study completion: 5 Feb 2024 (actual)
First posted: 28 Nov 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3
Model description: 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.

Arm	Type	Receives
mindfulness group	Experimental	Behavioral: mindfulness trainingStudy 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.
non-mindfulness group	Sham comparator	Behavioral: non-mindfulness trainingStudy volunteers will participate in a six-session meditation training regimen. In brief, subjects will be taught to take deep breaths and relax.
book-listening	Active comparator	Behavioral: book-listeningStudy 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
mindfulness trainingAlso: mental trainingA 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.	Behavioural	mindfulness group
non-mindfulness trainingAlso: mental trainingA 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.	Behavioural	non-mindfulness group
book-listeningStudy volunteers will listen to The Natural History and Antiquities of Selborne throughout the intervention.	Behavioural	book-listening

Primary outcome

Cerebral Blood Flow (average blood perfusion; mL blood/100 grams tissue/minute)
Time frame: 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.
Changes in cerebral blood flow will be assessed during pseudo continuous arterial spin labeling fMRI during their respective manipulations.

12 secondary outcomes

Visual Analog Scale Pain Ratings
Time frame: 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
Time frame: Two fMRI sessions. Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
Blood Oxygen Dependent Signaling
Time frame: Two fMRI sessions. Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
Respiration Rate
Time frame: 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
Time frame: 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.
PROMIS Pain Behavior Measure
Time frame: 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.
Brief Pain Inventory
Time frame: 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.
Pain Catastrophizing Scale
Time frame: 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.
Beck Depression Inventory
Time frame: 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.
Freiburg Mindfulness Inventory
Time frame: 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.
Roland-Morris Disability Questionnaire
Time frame: 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.
Cohen Perceived Stress Scale
Time frame: 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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
Background: PubMed 11166937Apkarian AV, Krauss BR, Fredrickson BE, Szeverenyi NM. Imaging the pain of low back pain: functional magnetic resonance imaging in combination with monitoring subjective pain perception allows the study of clinical pain states. Neurosci Lett. 2001 Feb 16;299(1-2):57-60. doi: 10.1016/s0304-3940(01)01504-x.
Background: PubMed 24982755Bruno PA, Millar DP, Goertzen DA. Inter-rater agreement, sensitivity, and specificity of the prone hip extension test and active straight leg raise test. Chiropr Man Therap. 2014 Jun 16;22:23. doi: 10.1186/2045-709X-22-23. eCollection 2014.
Background: PubMed 26511911Chen X, Spaeth RB, Freeman SG, Scarborough DM, Hashmi JA, Wey HY, Egorova N, Vangel M, Mao J, Wasan AD, Edwards RR, Gollub RL, Kong J. The modulation effect of longitudinal acupuncture on resting state functional connectivity in knee osteoarthritis patients. Mol Pain. 2015 Oct 29;11:67. doi: 10.1186/s12990-015-0071-9.
Background: PubMed 17523994Cropley M, Ussher M, Charitou E. Acute effects of a guided relaxation routine (body scan) on tobacco withdrawal symptoms and cravings in abstinent smokers. Addiction. 2007 Jun;102(6):989-93. doi: 10.1111/j.1360-0443.2007.01832.x.
Background: PubMed 14499421Eisenach JC, Rauck RL, Curry R. Intrathecal, but not intravenous adenosine reduces allodynia in patients with neuropathic pain. Pain. 2003 Sep;105(1-2):65-70. doi: 10.1016/s0304-3959(03)00158-1.
Background: PubMed 14736582Eisenach JC, Thomas JA, Rauck RL, Curry R, Li X. Cystatin C in cerebrospinal fluid is not a diagnostic test for pain in humans. Pain. 2004 Feb;107(3):207-212. doi: 10.1016/j.pain.2003.09.007.
Background: PubMed 11242371Fardon DF. Nomenclature and classification of lumbar disc pathology. Spine (Phila Pa 1976). 2001 Mar 1;26(5):461-2. doi: 10.1097/00007632-200103010-00007. No abstract available.
Background: PubMed 24768732Fardon DF, Williams AL, Dohring EJ, Murtagh FR, Gabriel Rothman SL, Sze GK. Lumbar disc nomenclature: version 2.0: Recommendations of the combined task forces of the North American Spine Society, the American Society of Spine Radiology and the American Society of Neuroradiology. Spine J. 2014 Nov 1;14(11):2525-45. doi: 10.1016/j.spinee.2014.04.022. Epub 2014 Apr 24.
Background: PubMed 20334973Jamison RN, Ross EL, Michna E, Chen LQ, Holcomb C, Wasan AD. Substance misuse treatment for high-risk chronic pain patients on opioid therapy: a randomized trial. Pain. 2010 Sep;150(3):390-400. doi: 10.1016/j.pain.2010.02.033. Epub 2010 Mar 23.
Background: PubMed 23995959Kwong EH, Virani N, Robert M, Gerry K, Harding A, Rose MS, Dukelow SP, Barton PM. Inter-rater reliability of the Active Straight-Leg Raise and One-Leg Standing tests in non-pregnant women. J Rehabil Med. 2013 Nov;45(10):1058-64. doi: 10.2340/16501977-1213.
BackgroundLazar N (2008) The Statistical Analysis of Functional MRI Data. New York, New York: Springer.
Background: PubMed 23111164Loggia ML, Kim J, Gollub RL, Vangel MG, Kirsch I, Kong J, Wasan AD, Napadow V. Default mode network connectivity encodes clinical pain: an arterial spin labeling study. Pain. 2013 Jan;154(1):24-33. doi: 10.1016/j.pain.2012.07.029. Epub 2012 Oct 27.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fadel Zeidan, PhD principal investigator

Principal Investigator

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing mindfulness training, non-mindfulness training and book-listening in people with Chronic Low Back Pain, run by University of California, San Diego at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cerebral Blood Flow (average blood perfusion; mL blood/100 grams tissue/minute) (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03354585, which also lists 34 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.