Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
151 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-08-07
Study Completion Date
2019-11-26
Brief Summary
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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.
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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Detailed Description
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Conditions
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Chronic Pain
Back Pain Lower Back Chronic
Back Pain, Low
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Researchers will not know which treatment the participants will be receiving (placebo or psychotherapy).
Study Groups
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Placebo
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.
Group Type
EXPERIMENTAL
Open-Label Placebo Treatment for Chronic Back Pain
Intervention Type
OTHER
Subcutaneous injection of 1ml medical grade saline into the lower back.
Psychotherapy
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.
Group Type
EXPERIMENTAL
Psychotherapy Treatment for Chronic Back Pain
Intervention Type
BEHAVIORAL
Twice weekly 50 minute psychotherapy sessions for 4 weeks, plus an initial medical history session
Waitlist
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).
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Open-Label Placebo Treatment for Chronic Back Pain
Subcutaneous injection of 1ml medical grade saline into the lower back.
Intervention Type
OTHER
Psychotherapy Treatment for Chronic Back Pain
Twice weekly 50 minute psychotherapy sessions for 4 weeks, plus an initial medical history session
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* Participants aged 21 to 70 with CBP will be enrolled.
* CBP will be defined according to the criteria established by a recent NIH task force (Deyo et al., 2014). Pain duration must be at least 3 months, with back pain being an ongoing problem for at least half the days of the last 6 months. That is, patients can meet criteria by either reporting pain every day for the past 3 months, or by reporting pain on half or more of the days for the past 6+ months. This will be determined by asking patients: (1) How long has back pain has been an ongoing problem for you? (2) How often has low back pain been an ongoing problem for you over the past 6 months? A response of greater than 3 months to question 1 and a response of ''at least half the days in the past 6 months'' to question 2 would define CBP.
* Back pain must be elicited by our back pain device (see below).
* Participants must also be comfortable and able to communicate via email or text message, as several study measures are collected in this manner (see below).
* CBP will be defined according to the criteria established by a recent NIH task force (Deyo et al., 2014). Pain duration must be at least 3 months, with back pain being an ongoing problem for at least half the days of the last 6 months. That is, patients can meet criteria by either reporting pain every day for the past 3 months, or by reporting pain on half or more of the days for the past 6+ months. This will be determined by asking patients: (1) How long has back pain has been an ongoing problem for you? (2) How often has low back pain been an ongoing problem for you over the past 6 months? A response of greater than 3 months to question 1 and a response of ''at least half the days in the past 6 months'' to question 2 would define CBP.
* Back pain must be elicited by our back pain device (see below).
* Participants must also be comfortable and able to communicate via email or text message, as several study measures are collected in this manner (see below).
Exclusion Criteria
* Back pain associated with compensation or litigation issues as determined by self-report within the past year.
* Leg pain is greater than back pain. This suggests neuropathic pain, which may be less responsive to placebo or psychotherapy.
* Difficulty participating for technical/logistical issues (e.g., unable to get to assessment sessions).
* Self-reported diagnoses of schizophrenia, multiple personality disorder, or dissociative identity disorder.
* Self-reported use of intravenous drugs, due to concerns about infections and subject compliance with experimental protocols.
* Inability to undergo MRI as determined by MRI safety screen (e.g., pregnancy, metal in body, claustrophobia, using the standard screen conducted by the MRI imaging facility).
* Hypersensitive or hyposensitive to pressure pain: unable to tolerate 7kg/cm2 stimulation or reporting no pain for 4kg/cm2 stimulation; see further details below.
* Current regular use of an immunosuppressant drug, such as steroids. Such drugs interfere with immunoassay results.
* Self-reported history of metastasizing cancers-cancer of the breast, thyroid, lung, kidney, prostate or blood cancers.
* Self-reported history of stroke, brain surgery, or brain tumor.
* Self-reported diagnosis of a specific inflammatory disorder: rheumatoid arthritis, polymyalgia rheumatica, scleroderma, Lupus, or polymyositis.
* Unexplained, unintended weight loss of 20 lbs. or more in the past year.
* Cauda Equina syndrome, as screened for by self-reported inability to control bowel or bladder function.
* Leg pain is greater than back pain. This suggests neuropathic pain, which may be less responsive to placebo or psychotherapy.
* Difficulty participating for technical/logistical issues (e.g., unable to get to assessment sessions).
* Self-reported diagnoses of schizophrenia, multiple personality disorder, or dissociative identity disorder.
* Self-reported use of intravenous drugs, due to concerns about infections and subject compliance with experimental protocols.
* Inability to undergo MRI as determined by MRI safety screen (e.g., pregnancy, metal in body, claustrophobia, using the standard screen conducted by the MRI imaging facility).
* Hypersensitive or hyposensitive to pressure pain: unable to tolerate 7kg/cm2 stimulation or reporting no pain for 4kg/cm2 stimulation; see further details below.
* Current regular use of an immunosuppressant drug, such as steroids. Such drugs interfere with immunoassay results.
* Self-reported history of metastasizing cancers-cancer of the breast, thyroid, lung, kidney, prostate or blood cancers.
* Self-reported history of stroke, brain surgery, or brain tumor.
* Self-reported diagnosis of a specific inflammatory disorder: rheumatoid arthritis, polymyalgia rheumatica, scleroderma, Lupus, or polymyositis.
* Unexplained, unintended weight loss of 20 lbs. or more in the past year.
* Cauda Equina syndrome, as screened for by self-reported inability to control bowel or bladder function.
Minimum Eligible Age
21 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Radiological Society of North America
OTHER
Sponsor Role
collaborator
National Institutes of Health (NIH)
NIH
Sponsor Role
collaborator
Psychophysiologic Disorders Society
OTHER
Sponsor Role
collaborator
Foundation for the Science of Therapeutic Encounter
OTHER
Sponsor Role
collaborator
University of Colorado, Boulder
OTHER
Sponsor Role
lead
Responsible Party
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Jonathan Ashar
Graduate student under the supervision of PI Wager
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Tor Wager
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Boulder
Locations
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University of Colorado Boulder
Boulder, Colorado, United States
Site Status
Countries
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United States
References
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Winston JS, Vlaev I, Seymour B, Chater N, Dolan RJ. Relative valuation of pain in human orbitofrontal cortex. J Neurosci. 2014 Oct 29;34(44):14526-35. doi: 10.1523/JNEUROSCI.1706-14.2014.
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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.
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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.
Reference Type
DERIVED
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form: Placebo
Document Type: Informed Consent Form: Control
Document Type: Informed Consent Form: Psychotherapy
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
16-0544
Identifier Type: -
Identifier Source: org_study_id
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