Mind-body Treatments for Chronic Back Pain

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

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

Sponsors & Collaborators

• Radiological Society of North America

  collaborator OTHER

• National Institutes of Health (NIH)

  collaborator NIH

• Psychophysiologic Disorders Society

  collaborator OTHER

• Foundation for the Science of Therapeutic Encounter

  collaborator OTHER

• University of Colorado, Boulder

  lead OTHER

Principal Investigators

• Tor Wager · University of Colorado, Boulder

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-08-07

Primary Completion

2018-11-25

Completion

2019-11-26

Countries

• United States

Study Locations