NCT03294148

Mind-body Treatments for Chronic Back Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: University of Colorado, Boulder · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Pain
• Back Pain Lower Back Chronic
• Back Pain, Low

Interventions

Type	Name	Description
OTHER	Open-Label Placebo Treatment for Chronic Back Pain	Subcutaneous injection of 1ml medical grade saline into the lower back.
BEHAVIORAL	Psychotherapy Treatment for Chronic Back Pain	Twice weekly 50 minute psychotherapy sessions for 4 weeks, plus an initial medical history session

Timeline

• Start date: 2017-08-07
• Primary completion: 2018-11-25
• Completion: 2019-11-26
• First posted: 2017-09-26
• Last updated: 2023-03-22
• Results posted: 2023-03-22

Locations

1 site across 1 country: United States