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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
151
Subcutaneous injection of 1ml medical grade saline into the lower back.
Twice weekly 50 minute psychotherapy sessions for 4 weeks, plus an initial medical history session
University of Colorado Boulder
Boulder, Colorado, United States
Brief Pain Inventory-Short Form (BPI-SF)
1-week average pain intensity, 0 - 10 numerical rating scale, where a higher score indicates more pain.
Time frame: At post-treatment fMRI session, approximately 1 month after randomization
Positive Affect Scale Short Form (PANAS-SF)
Questionnaire to rate positive affect, scores range from 5 - 25, a higher score means stronger affect
Time frame: At post-treatment fMRI session, approximately 1 month after randomization
PROMIS- Depression
Questionnaire measuring depression (8 items). Scores range from 8-32. A higher score indicates higher levels of depressive symptoms
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: 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/
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: At post-treatment fMRI session, approximately 1 month after randomization
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