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| Name | Class |
|---|---|
| Radiological Society of North America | OTHER |
| National Institutes of Health (NIH) | NIH |
| Psychophysiologic Disorders Society | OTHER |
| Foundation for the Science of Therapeutic Encounter |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Experimental | The open-label placebo treatment the investigators will use is based on past open-label placebo trials (Kam-Hansen et al., 2014; Kaptchuk et al., 2010; Kelley et al., 2012). Prior to treatment administration, patients will view a brief (~3 min) video summarizing scientific findings regarding the therapeutic power of placebo treatments. The video will describe established findings regarding placebo and suggest that placebos may still work even when patients know the treatment is a placebo. The video will state that believing in the placebo is not necessary, and the investigators ask only that patients keep an open mind. Patients will then receive a subcutaneous injection of 1ml medical grade saline into the lower back. The injection will be administered near the location of the pain, as specified by the participant. The investigators will use a standard needle used in subcutaneous injections of 27 gauge with a length from 1in to 1.5in. |
|
| Psychotherapy | Experimental | Psychotherapy will consist of one initial medical history session with Co-I Schubiner, followed by twice weekly 50 minute psychotherapy sessions for 4 weeks with a therapist, for a total of 9 sessions maximum. The purpose of the initial medical history session is to help evaluate the likelihood that the patient's back pain is caused by structural conditions in the back. Dr. Schubiner will then speak with patients for a 1 hour session in which he collects their medical history and discusses different possible causes of their back pain with them. This session will be conducted by phone, by HIPAA-compliant Zoom, or by another HIPAA-compliant videoconferencing technology in consultation with the OIT team at Dr. Schubiner's hospital. |
|
| Waitlist | No Intervention | Wait-listed patients will be asked not to change their treatment regime for the 4 weeks in between their two fMRI sessions. Wait-listed patients in the placebo injection arm will be offered the opportunity to receive the placebo treatment (optional). Waitlisted participants in the psychotherapy arm will be given a copy of Dr. Schubiner's book and free access to his online self-help program (optional to accept these). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open-Label Placebo Treatment for Chronic Back Pain | Other | Subcutaneous injection of 1ml medical grade saline into the lower back. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory-Short Form (BPI-SF) | 1-week average pain intensity, 0 - 10 numerical rating scale, where a higher score indicates more pain. | At post-treatment fMRI session, approximately 1 month after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Positive Affect Scale Short Form (PANAS-SF) | Questionnaire to rate positive affect, scores range from 5 - 25, a higher score means stronger affect | At post-treatment fMRI session, approximately 1 month after randomization |
| PROMIS- Depression |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tor Wager | University of Colorado, Boulder | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Boulder | Boulder | Colorado | 80309 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17040533 | Background | Annersten M, Willman A. Performing subcutaneous injections: a literature review. Worldviews Evid Based Nurs. 2005;2(3):122-30. doi: 10.1111/j.1741-6787.2005.00030.x. | |
| 28375723 | Background | Ashar YK, Chang LJ, Wager TD. Brain Mechanisms of the Placebo Effect: An Affective Appraisal Account. Annu Rev Clin Psychol. 2017 May 8;13:73-98. doi: 10.1146/annurev-clinpsy-021815-093015. Epub 2017 Mar 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pain Reprocessing Therapy (PRT) | Received psychological treatment |
| FG001 | Placebo | Open-label placebo |
| FG002 | Usual Care | Continue usual care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pain Reprocessing Therapy (PRT) | Received psychological treatment |
| BG001 | Placebo | Open-label placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Brief Pain Inventory-Short Form (BPI-SF) | 1-week average pain intensity, 0 - 10 numerical rating scale, where a higher score indicates more pain. | all available participants analyzed | Posted | Mean | Standard Deviation | units on a scale | At post-treatment fMRI session, approximately 1 month after randomization |
|
Adverse events were collected from enrollment through completion of the post-treatment fMRI session, an average of 1.5 months after enrollment.
Adverse events were recorded when participants spontaneously reported them to study personnel.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pain Reprocessing Therapy (PRT) | Psychological treatment | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yoni Ashar | Weill Cornell Medicine | (646) 962-2820 | joa9188@med.cornell.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 5, 2018 | Nov 21, 2018 | Prot_SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form: Placebo | Jul 23, 2018 | Nov 21, 2018 | ICF_005.pdf |
| ICF | No | No | Yes | Informed Consent Form: Control | Jul 23, 2018 | Nov 21, 2018 | ICF_006.pdf |
| ICF | No | No | Yes | Informed Consent Form: Psychotherapy | Jul 23, 2018 | Nov 21, 2018 | ICF_007.pdf |
Not provided
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D017116 | Low Back Pain |
| D010146 | Pain |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
Not provided
Not provided
| OTHER |
Participants will 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. After an eligibility session, eligible participants will 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.
Not provided
Not provided
Researchers will not know which treatment the participants will be receiving (placebo or psychotherapy).
| Psychotherapy Treatment for Chronic Back Pain | Behavioral | Twice weekly 50 minute psychotherapy sessions for 4 weeks, plus an initial medical history session |
|
Questionnaire measuring depression (8 items). Scores range from 8-32. A higher score indicates higher levels of depressive symptoms
| At post-treatment fMRI session, approximately 1 month after randomization |
| Tampa Scale of Kinesiophobia (TSK) | Questionnaire used to assess the subjective rating of kinesiophobia or fear of movement. Scores range from 11-44 with higher scores indicating greater fear of pain, movement, and injury. | At post-treatment fMRI session, approximately 1 month after randomization |
| Pain Catastrophizing Questionnaire (PCS) | Questionnaire used to help quantify an individual's pain experience. Measured 0-52. A higher score means a higher level of catastrophizing. | At post-treatment fMRI session, approximately 1 month after randomization |
| Timeline Follow-Back Measure for Alcohol (TLFB) | Questionnaire used to assess daily drinking (number of drinks consumed over past two weeks) | At post-treatment fMRI session, approximately 1 month after randomization |
| Patient Global Impression of Change (PGIC) | Post-treatment-only outcome measure depicting a patient's subjective rating of overall improvement. Score ranges from 1-7 with a higher score indicating a higher level of change and improvement | At post-treatment fMRI session, approximately 1 month after randomization |
| Treatment Satisfaction Questionnaire | Post-treatment-only outcome measure depicting the patient's satisfaction with the treatment. Measured 0 - 100. A higher score means higher satisfaction with treatment/ | At post-treatment fMRI session, approximately 1 month after randomization |
| Oswestry Disability Index | Back pain disability questionnaire measured on a scale of 0-100. A higher score indicates a higher severity of disability. | At post-treatment fMRI session, approximately 1 month after randomization |
| Negative Affect Scale Short Form (PANAS-SF) | Questionnaire to rate negative affect, scores range from 5 - 25, with a higher score meaning a stronger negative affect | At post-treatment fMRI session, approximately 1 month after randomization |
| PROMIS Anger | Questionnaire measuring anger (5 items) with a score range of 5-25. Higher scores indicate a higher severity of anger. | At post-treatment fMRI session, approximately 1 month after randomization |
| PROMIS Sleep | Questionnaire measuring sleep disturbance (8 items). Scores range from 8-40. Higher scores indicate higher levels of sleep disturbance | At post-treatment fMRI session, approximately 1 month after randomization |
| PROMIS Anxiety | Questionnaire measuring anxiety (8 items). Scores range from 8-40 with a higher score meaning more severe levels of fear, anxious misery, hyperarousal, and somatic symptoms related to arousal. | At post-treatment fMRI session, approximately 1 month after randomization |
| Timeline Follow-Back Measure for Opioid Use (TLFB) | Questionnaire used to assess daily opioid use (number of pills consumed over past two weeks) | At post-treatment fMRI session, approximately 1 month after randomization |
| Timeline Follow-Back Measure for Cannabis (TLFB) | Questionnaire used to assess daily cannabis use (number of grams consumed over past two weeks) | At post-treatment fMRI session, approximately 1 month after randomization |
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| 18948346 | Background | Tilburt JC, Emanuel EJ, Kaptchuk TJ, Curlin FA, Miller FG. Prescribing "placebo treatments": results of national survey of US internists and rheumatologists. BMJ. 2008 Oct 23;337:a1938. doi: 10.1136/bmj.a1938. |
| 26307858 | Background | Tuttle AH, Tohyama S, Ramsay T, Kimmelman J, Schweinhardt P, Bennett GJ, Mogil JS. Increasing placebo responses over time in U.S. clinical trials of neuropathic pain. Pain. 2015 Dec;156(12):2616-2626. doi: 10.1097/j.pain.0000000000000333. |
| 27190016 | Background | Vachon-Presseau E, Tetreault P, Petre B, Huang L, Berger SE, Torbey S, Baria AT, Mansour AR, Hashmi JA, Griffith JW, Comasco E, Schnitzer TJ, Baliki MN, Apkarian AV. Corticolimbic anatomical characteristics predetermine risk for chronic pain. Brain. 2016 Jul;139(Pt 7):1958-70. doi: 10.1093/brain/aww100. Epub 2016 May 5. |
| 23148449 | Background | Vlaev I, Seymour B, Chater N, Winston JS, Yoshida W, Wright N, Symmonds M, Dolan R. Prices need no preferences: social trends determine decisions in experimental markets for pain relief. Health Psychol. 2014 Jan;33(1):66-76. doi: 10.1037/a0030372. Epub 2012 Nov 12. |
| 19254237 | Background | Vlaev I, Seymour B, Dolan RJ, Chater N. The price of pain and the value of suffering. Psychol Sci. 2009 Mar;20(3):309-17. doi: 10.1111/j.1467-9280.2009.02304.x. Epub 2009 Feb 23. |
| 26087681 | Background | Wager TD, Atlas LY. The neuroscience of placebo effects: connecting context, learning and health. Nat Rev Neurosci. 2015 Jul;16(7):403-18. doi: 10.1038/nrn3976. |
| 21228154 | Background | Wager TD, Atlas LY, Leotti LA, Rilling JK. Predicting individual differences in placebo analgesia: contributions of brain activity during anticipation and pain experience. J Neurosci. 2011 Jan 12;31(2):439-52. doi: 10.1523/JNEUROSCI.3420-10.2011. |
| 23574118 | Background | Wager TD, Atlas LY, Lindquist MA, Roy M, Woo CW, Kross E. An fMRI-based neurologic signature of physical pain. N Engl J Med. 2013 Apr 11;368(15):1388-97. doi: 10.1056/NEJMoa1204471. |
| 14976306 | Background | Wager TD, Rilling JK, Smith EE, Sokolik A, Casey KL, Davidson RJ, Kosslyn SM, Rose RM, Cohen JD. Placebo-induced changes in FMRI in the anticipation and experience of pain. Science. 2004 Feb 20;303(5661):1162-7. doi: 10.1126/science.1093065. |
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| 39259542 | Derived | Ashar YK, Sun M, Knight K, Flood TF, Anderson Z, Kaptchuk TJ, Wager TD. Open-Label Placebo Injection for Chronic Back Pain With Functional Neuroimaging: A Randomized Clinical Trial. JAMA Netw Open. 2024 Sep 3;7(9):e2432427. doi: 10.1001/jamanetworkopen.2024.32427. |
| 34586357 | Derived | Ashar YK, Gordon A, Schubiner H, Uipi C, Knight K, Anderson Z, Carlisle J, Polisky L, Geuter S, Flood TF, Kragel PA, Dimidjian S, Lumley MA, Wager TD. Effect of Pain Reprocessing Therapy vs Placebo and Usual Care for Patients With Chronic Back Pain: A Randomized Clinical Trial. JAMA Psychiatry. 2022 Jan 1;79(1):13-23. doi: 10.1001/jamapsychiatry.2021.2669. |
| BG002 |
| Usual Care |
Continue usual care |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Continue usual care |
|
|
| Secondary | Positive Affect Scale Short Form (PANAS-SF) | Questionnaire to rate positive affect, scores range from 5 - 25, a higher score means stronger affect | all available participants analyzed | Posted | Mean | Standard Deviation | score on a scale | At post-treatment fMRI session, approximately 1 month after randomization |
|
|
|
| Secondary | PROMIS- Depression | Questionnaire measuring depression (8 items). Scores range from 8-32. A higher score indicates higher levels of depressive symptoms | all available participants analyzed | Posted | Mean | Standard Deviation | score on a scale | At post-treatment fMRI session, approximately 1 month after randomization |
|
|
|
| Secondary | Tampa Scale of Kinesiophobia (TSK) | Questionnaire used to assess the subjective rating of kinesiophobia or fear of movement. Scores range from 11-44 with higher scores indicating greater fear of pain, movement, and injury. | all available participants analyzed | Posted | Mean | Standard Deviation | score on a scale | At post-treatment fMRI session, approximately 1 month after randomization |
|
|
|
| Secondary | Pain Catastrophizing Questionnaire (PCS) | Questionnaire used to help quantify an individual's pain experience. Measured 0-52. A higher score means a higher level of catastrophizing. | all available participants analyzed | Posted | Mean | Standard Deviation | score on a scale | At post-treatment fMRI session, approximately 1 month after randomization |
|
|
|
| Secondary | Timeline Follow-Back Measure for Alcohol (TLFB) | Questionnaire used to assess daily drinking (number of drinks consumed over past two weeks) | all available participants analyzed | Posted | Mean | Standard Deviation | Drinks | At post-treatment fMRI session, approximately 1 month after randomization |
|
|
|
| Secondary | Patient Global Impression of Change (PGIC) | Post-treatment-only outcome measure depicting a patient's subjective rating of overall improvement. Score ranges from 1-7 with a higher score indicating a higher level of change and improvement | all available participants analyzed | Posted | Mean | Standard Deviation | score on a scale | At post-treatment fMRI session, approximately 1 month after randomization |
|
|
|
| Secondary | Treatment Satisfaction Questionnaire | Post-treatment-only outcome measure depicting the patient's satisfaction with the treatment. Measured 0 - 100. A higher score means higher satisfaction with treatment/ | all available participants analyzed | Posted | Mean | Standard Deviation | score on a scale | At post-treatment fMRI session, approximately 1 month after randomization |
|
|
|
| Secondary | Oswestry Disability Index | Back pain disability questionnaire measured on a scale of 0-100. A higher score indicates a higher severity of disability. | all available participants analyzed | Posted | Mean | Standard Deviation | score on a scale | At post-treatment fMRI session, approximately 1 month after randomization |
|
|
|
| Secondary | Negative Affect Scale Short Form (PANAS-SF) | Questionnaire to rate negative affect, scores range from 5 - 25, with a higher score meaning a stronger negative affect | all available participants analyzed | Posted | Mean | Standard Deviation | score on a scale | At post-treatment fMRI session, approximately 1 month after randomization |
|
|
|
| Secondary | PROMIS Anger | Questionnaire measuring anger (5 items) with a score range of 5-25. Higher scores indicate a higher severity of anger. | all available participants analyzed | Posted | Mean | Standard Deviation | score on a scale | At post-treatment fMRI session, approximately 1 month after randomization |
|
|
|
| Secondary | PROMIS Sleep | Questionnaire measuring sleep disturbance (8 items). Scores range from 8-40. Higher scores indicate higher levels of sleep disturbance | all available participants analyzed | Posted | Mean | Standard Deviation | score on a scale | At post-treatment fMRI session, approximately 1 month after randomization |
|
|
|
| Secondary | PROMIS Anxiety | Questionnaire measuring anxiety (8 items). Scores range from 8-40 with a higher score meaning more severe levels of fear, anxious misery, hyperarousal, and somatic symptoms related to arousal. | all available participants analyzed | Posted | Mean | Standard Deviation | score on a scale | At post-treatment fMRI session, approximately 1 month after randomization |
|
|
|
| Secondary | Timeline Follow-Back Measure for Opioid Use (TLFB) | Questionnaire used to assess daily opioid use (number of pills consumed over past two weeks) | all available participants analyzed | Posted | Mean | Standard Deviation | Opioid pills | At post-treatment fMRI session, approximately 1 month after randomization |
|
|
|
| Secondary | Timeline Follow-Back Measure for Cannabis (TLFB) | Questionnaire used to assess daily cannabis use (number of grams consumed over past two weeks) | all available participants analyzed | Posted | Mean | Standard Deviation | Grams of cannabis | At post-treatment fMRI session, approximately 1 month after randomization |
|
|
|
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Placebo | Open-label placebo | 0 | 51 | 0 | 51 | 0 | 51 |
| EG002 | Usual Care | Continue usual care | 0 | 50 | 0 | 50 | 0 | 50 |
Not provided
Not provided
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |