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Mind-body Treatments for Chronic Back Pain

NCT03294148

NAINTERVENTIONAL
University of Colorado, Boulder
151 participants
Started 2017-08-07 · Completed 2019-11-26
Status: Completed (as of 12-23-2025)

Conditions

Chronic PainBack Pain Lower Back ChronicBack Pain, Low

Linked Papers (from SciSciNet-V2)

Total Papers65
Background
39
Result
0
Derived
0
Unknown
26

Total Citations Per Year

Brief Summary

Participants with chronic back pain will complete an online prescreen. They will then be randomized to one of two different studies: a placebo vs. waitlist study or a psychotherapy vs. waitlist study, with randomization stratified on pain intensity, age, gender, and opioid use. Participants will then complete an in-person eligibility session, and eligible participants will be scheduled for the baseline assessment session. Following the baseline assessment session, participants will then be randomized to the treatment group or the waitlist group (with a ratio of 2:1 treatment:waitlist), using a computer-generated random sequence. This scheme will result in three equally sized groups-placebo, psychotherapy, and waitlist-as the investigators will collapse data from the waitlist arms in the two studies for analyses. The investigators do not use a standard three-way randomization because the investigators do not want placebo participants to think they are in a control condition. Thus, the investigators constrain participant's expectations to either injection vs. waitlist or to psychotherapy vs. waitlist. The placebo treatment is a subcutaneous injection of saline into the back. Participants will know that the treatment is a placebo, i.e., it is an "open label" placebo. Psychotherapy (8 sessions) will be supervised by Alan Gordon and Howard Schubiner. Functional MRI brain imaging, self-reported clinical outcomes, and behavioral measures will be collected pre- and post-treatment. A brief follow-up survey will be sent at months 1, 2, 3, 6, and 12 after the final assessment session. These will provide longer term data about the trajectory and durability of patient improvement. Additionally, a group of healthy controls, with no history of back pain, will complete the baseline assessment. They will serve as a comparison group to probe whether the patterns of observed brain activity is specific to CBP patients.

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Background Papers77

Cognitive and emotional control of pain and its disruption in chronic pain
2013
1,663 citations
Cognitive and emotional control of pain and its disruption in chronic pain
2013
1,663 citations
The Rising Prevalence of Chronic Low Back Pain
2009
1,431 citations
The Rising Prevalence of Chronic Low Back Pain
2009
1,431 citations
Corticostriatal functional connectivity predicts transition to chronic back pain
2012
943 citations
Corticostriatal functional connectivity predicts transition to chronic back pain
2012
943 citations
Placebos without Deception: A Randomized Controlled Trial in Irritable Bowel Syndrome
2010
816 citations
Placebos without Deception: A Randomized Controlled Trial in Irritable Bowel Syndrome
2010
816 citations
Pathological pain and the neuroimmune interface
2014
772 citations
Pathological pain and the neuroimmune interface
2014
772 citations
Placebo interventions for all clinical conditions
2010
707 citations
Placebo interventions for all clinical conditions
2010
707 citations
The neuroscience of placebo effects: connecting context, learning and health
2015
665 citations
The neuroscience of placebo effects: connecting context, learning and health
2015
665 citations
Shape shifting pain: chronification of back pain shifts brain representation from nociceptive to emotional circuits
2013
662 citations
Shape shifting pain: chronification of back pain shifts brain representation from nociceptive to emotional circuits
2013
662 citations
Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain
2016
594 citations
Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain
2016
594 citations
Effective Treatment of Chronic Low Back Pain in Humans Reverses Abnormal Brain Anatomy and Function
2011
560 citations
Effective Treatment of Chronic Low Back Pain in Humans Reverses Abnormal Brain Anatomy and Function
2011
560 citations
Brain Mediators of Predictive Cue Effects on Perceived Pain
2010
386 citations
Brain Mediators of Predictive Cue Effects on Perceived Pain
2010
386 citations
Altered Placebo and Drug Labeling Changes the Outcome of Episodic Migraine Attacks
2014
360 citations
Altered Placebo and Drug Labeling Changes the Outcome of Episodic Migraine Attacks
2014
360 citations
Corticolimbic anatomical characteristics predetermine risk for chronic pain
2016
320 citations
Corticolimbic anatomical characteristics predetermine risk for chronic pain
2016
320 citations
Predicting Individual Differences in Placebo Analgesia: Contributions of Brain Activity during Anticipation and Pain Experience
2011
314 citations
The role of the striatum in aversive learning and aversive prediction errors
2008
307 citations
The role of the striatum in aversive learning and aversive prediction errors
2008
307 citations
How the number of learning trials affects placebo and nocebo responses
2010
283 citations
How the number of learning trials affects placebo and nocebo responses
2010
283 citations
Prescribing "placebo treatments": results of national survey of US internists and rheumatologists
2008
253 citations
Prescribing "placebo treatments": results of national survey of US internists and rheumatologists
2008
253 citations
Decreased motivation during chronic pain requires long-term depression in the nucleus accumbens
2014
247 citations
Decreased motivation during chronic pain requires long-term depression in the nucleus accumbens
2014
247 citations
Activation of Corticostriatal Circuitry Relieves Chronic Neuropathic Pain
2015
241 citations
Activation of Corticostriatal Circuitry Relieves Chronic Neuropathic Pain
2015
241 citations
Representation of aversive prediction errors in the human periaqueductal gray
2014
237 citations
Representation of aversive prediction errors in the human periaqueductal gray
2014
237 citations
Ecological momentary assessment versus standard assessment instruments for measuring mindfulness, depressed mood, and anxiety among older adults
2016
230 citations
Ecological momentary assessment versus standard assessment instruments for measuring mindfulness, depressed mood, and anxiety among older adults
2016
230 citations
The power of context: reconceptualizing the placebo effect
2008
215 citations
The power of context: reconceptualizing the placebo effect
2008
215 citations
Staying well during pregnancy and the postpartum: A pilot randomized trial of mindfulness-based cognitive therapy for the prevention of depressive relapse/recurrence.
2015
184 citations
Staying well during pregnancy and the postpartum: A pilot randomized trial of mindfulness-based cognitive therapy for the prevention of depressive relapse/recurrence.
2015
184 citations
Facilitation of Pain in the Human Spinal Cord by Nocebo Treatment
2013
138 citations
Facilitation of Pain in the Human Spinal Cord by Nocebo Treatment
2013
138 citations
Cortical and subcortical responses to high and low effective placebo treatments
2012
126 citations
Cortical and subcortical responses to high and low effective placebo treatments
2012
126 citations
Brain networks predicting placebo analgesia in a clinical trial for chronic back pain
2012
110 citations
Conditioned Placebo Analgesia Persists When Subjects Know They Are Receiving a Placebo
2015
110 citations
Conditioned Placebo Analgesia Persists When Subjects Know They Are Receiving a Placebo
2015
110 citations
Brain networks predicting placebo analgesia in a clinical trial for chronic back pain
2012
110 citations
Are open‐Label Placebos Ethical? Informed Consent and Ethical Equivocations
2016
108 citations
Are open‐Label Placebos Ethical? Informed Consent and Ethical Equivocations
2016
108 citations
Sustained Pain Reduction Through Affective Self-awareness in Fibromyalgia: A Randomized Controlled Trial
2010
101 citations
Sustained Pain Reduction Through Affective Self-awareness in Fibromyalgia: A Randomized Controlled Trial
2010
101 citations
Patients' attitudes about the use of placebo treatments: telephone survey
2013
95 citations
Patients' attitudes about the use of placebo treatments: telephone survey
2013
95 citations
Unlearning chronic pain: A randomized controlled trial to investigate changes in intrinsic brain connectivity following Cognitive Behavioral Therapy
2014
94 citations
Unlearning chronic pain: A randomized controlled trial to investigate changes in intrinsic brain connectivity following Cognitive Behavioral Therapy
2014
94 citations
The Price of Pain and the Value of Suffering
2009
88 citations
The Price of Pain and the Value of Suffering
2009
88 citations
Beyond conformity: Social influences on pain reports and physiology.
2015
77 citations
Beyond conformity: Social influences on pain reports and physiology.
2015
77 citations
Relapse prevention in major depressive disorder: Mindfulness-based cognitive therapy versus an active control condition.
2015
72 citations
Relapse prevention in major depressive disorder: Mindfulness-based cognitive therapy versus an active control condition.
2015
72 citations
Striatal structure and function predict individual biases in learning to avoid pain
2016
69 citations
Striatal structure and function predict individual biases in learning to avoid pain
2016
69 citations
Relative Valuation of Pain in Human Orbitofrontal Cortex
2014
51 citations
Relative Valuation of Pain in Human Orbitofrontal Cortex
2014
51 citations
Lidocaine Patch (5%) is No More Potent than Placebo in Treating Chronic Back Pain When Tested in a Randomised Double Blind Placebo Controlled Brain Imaging Study
2012
40 citations
Lidocaine Patch (5%) is No More Potent than Placebo in Treating Chronic Back Pain When Tested in a Randomised Double Blind Placebo Controlled Brain Imaging Study
2012
40 citations
Patient attitudes about the clinical use of placebo: qualitative perspectives from a telephone survey
2016
27 citations
Patient attitudes about the clinical use of placebo: qualitative perspectives from a telephone survey
2016
27 citations
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Result Papers0

No result papers linked

Derived Papers0

No derived papers linked

Unknown Papers26

The biopsychosocial approach to chronic pain: Scientific advances and future directions.
2007
2,869 citations
Diagnosis and Treatment of Low Back Pain: A Joint Clinical Practice Guideline from the American College of Physicians and the American Pain Society
2007
2,561 citations
Placebo-Induced Changes in fMRI in the Anticipation and Experience of Pain
2004
1,961 citations
Psychometric properties of the credibility/expectancy questionnaire
2000
1,924 citations
Randomized trial of behavioral activation, cognitive therapy, and antidepressant medication in the acute treatment of adults with major depression.
2006
1,520 citations
Meta-analysis of psychological interventions for chronic low back pain.
2007
821 citations
German Acupuncture Trials (Gerac) For Chronic Low Back Pain<subtitle>Randomized, Multicenter, Blinded, Parallel-Group Trial With 3 Groups</subtitle>
2007
712 citations
Depressive disorders and immunity: 20 years of progress and discovery
2007
638 citations
The Placebo Effect in Alternative Medicine: Can the Performance of a Healing Ritual Have Clinical Significance?
2002
611 citations
Opponent appetitive-aversive neural processes underlie predictive learning of pain relief
2005
433 citations
How would we know if psychotherapy were harmful?
2010
288 citations
Structural and functional brain abnormalities in chronic low back pain: A systematic review☆
2015
261 citations
Increasing placebo responses over time in U.S. clinical trials of neuropathic pain
2015
211 citations
Management of low back pain
2008
178 citations
Brain Mechanisms of the Placebo Effect: An Affective Appraisal Account
2017
169 citations
Serum levels of the pro-inflammatory interleukins 6 (IL-6) and -8 (IL-8) in patients with lumbar radicular pain due to disc herniation: A 12-month prospective study
2015
103 citations
Growth of Spinal Interventional Pain Management Techniques
2012
85 citations
The Behavioral Activation and Inhibition Systems: Implications for Understanding and Treating Chronic Pain
2016
69 citations
Association between baseline <scp>IL</scp>‐6 and 1‐year recovery in lumbar radicular pain
2014
54 citations
Treatment history and placebo responses to experimental and clinical pain in chronic pain patients
2016
39 citations
Report of the National Institutes of Health Task Force on Research Standards for Chronic Low Back Pain
2014
38 citations
Performing Subcutaneous Injections: A Literature Review
2005
35 citations
Epidural Injections for Spinal Pain
2014
18 citations
Prices need no preferences: Social trends determine decisions in experimental markets for pain relief.
2012
7 citations
Predicting individual differences in placebo analgesia: Contributions of brain activity during anticipation and pain experience
2011
0 citations
Untitled
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