Mind-body Treatments for Chronic Back Pain
Condition: Chronic Pain; Back Pain Lower Back Chronic; Back Pain, Low
MeSH terms: Back Pain; Chronic Pain; Low Back Pain
Study type: Interventional

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.
    


Intervention name(s): Open-Label Placebo Treatment for Chronic Back Pain; Psychotherapy Treatment for Chronic Back Pain
Intervention type(s): Other; Behavioral
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Placebo; Back; Pain; Chronic; Mind-Body