At a glance
ClinicalIndex Comparison Record- ✓Age 21 to 70 years
- ✓Chronic back pain ≥3 months duration with pain on ≥50% of days in past 6 months
- ✓Pain intensity ≥40/100 on Brief Pain Inventory-Short Form (BPI-SF)
- ✓Back pain reproducible by study device
- ✕Leg pain greater than back pain (suggests neuropathic pain)
- ✕Back pain associated with compensation or litigation in past year
- ✕Schizophrenia, multiple personality disorder, or dissociative identity disorder
- ✕Current intravenous drug use
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Mind-body Treatments for Chronic Back Pain
In Brief
A clinical study evaluating Open-Label Placebo Treatment for Chronic Back Pain and Psychotherapy Treatment for Chronic Back Pain for Chronic Pain and 2 related conditions. Completed, enrolled 151 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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