Mind-body Treatments for Chronic Back Pain

February 24, 2023 updated by: Jonathan Ashar, University of Colorado, Boulder

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

151

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Boulder, Colorado, United States, 80309
        • University of Colorado Boulder

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants aged 21 to 70 with CBP will be enrolled.
  • CBP will be defined according to the criteria established by a recent NIH task force (Deyo et al., 2014). Pain duration must be at least 3 months, with back pain being an ongoing problem for at least half the days of the last 6 months. That is, patients can meet criteria by either reporting pain every day for the past 3 months, or by reporting pain on half or more of the days for the past 6+ months. This will be determined by asking patients: (1) How long has back pain has been an ongoing problem for you? (2) How often has low back pain been an ongoing problem for you over the past 6 months? A response of greater than 3 months to question 1 and a response of ''at least half the days in the past 6 months'' to question 2 would define CBP.
  • Patients must rate pain intensity at 40/100 or greater on the Brief Pain Inventory-Short Form (BPI-SF), in keeping with inclusion criteria from previous CBP trials (Baliki et al., 2012; Cherkin et al., 2016; Hashmi et al., 2013; Seminowicz et al., 2011).
  • Back pain must be elicited by our back pain device (see below).
  • Participants must also be comfortable and able to communicate via email or text message, as several study measures are collected in this manner (see below).

Exclusion Criteria:

  • Back pain associated with compensation or litigation issues as determined by self-report within the past year.
  • Leg pain is greater than back pain. This suggests neuropathic pain, which may be less responsive to placebo or psychotherapy.
  • Difficulty participating for technical/logistical issues (e.g., unable to get to assessment sessions).
  • Self-reported diagnoses of schizophrenia, multiple personality disorder, or dissociative identity disorder.
  • Self-reported use of intravenous drugs, due to concerns about infections and subject compliance with experimental protocols.
  • Inability to undergo MRI as determined by MRI safety screen (e.g., pregnancy, metal in body, claustrophobia, using the standard screen conducted by the MRI imaging facility).
  • Hypersensitive or hyposensitive to pressure pain: unable to tolerate 7kg/cm2 stimulation or reporting no pain for 4kg/cm2 stimulation; see further details below.
  • Current regular use of an immunosuppressant drug, such as steroids. Such drugs interfere with immunoassay results.
  • Self-reported history of metastasizing cancers-cancer of the breast, thyroid, lung, kidney, prostate or blood cancers.
  • Self-reported history of stroke, brain surgery, or brain tumor.
  • Self-reported diagnosis of a specific inflammatory disorder: rheumatoid arthritis, polymyalgia rheumatica, scleroderma, Lupus, or polymyositis.
  • Unexplained, unintended weight loss of 20 lbs. or more in the past year.
  • Cauda Equina syndrome, as screened for by self-reported inability to control bowel or bladder function.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Placebo
The open-label placebo treatment the investigators will use is based on past open-label placebo trials (Kam-Hansen et al., 2014; Kaptchuk et al., 2010; Kelley et al., 2012). Prior to treatment administration, patients will view a brief (~3 min) video summarizing scientific findings regarding the therapeutic power of placebo treatments. The video will describe established findings regarding placebo and suggest that placebos may still work even when patients know the treatment is a placebo. The video will state that believing in the placebo is not necessary, and the investigators ask only that patients keep an open mind. Patients will then receive a subcutaneous injection of 1ml medical grade saline into the lower back. The injection will be administered near the location of the pain, as specified by the participant. The investigators will use a standard needle used in subcutaneous injections of 27 gauge with a length from 1in to 1.5in.
Other: Open-Label Placebo Treatment for Chronic Back Pain
Subcutaneous injection of 1ml medical grade saline into the lower back.
Experimental: Psychotherapy
Psychotherapy will consist of one initial medical history session with Co-I Schubiner, followed by twice weekly 50 minute psychotherapy sessions for 4 weeks with a therapist, for a total of 9 sessions maximum. The purpose of the initial medical history session is to help evaluate the likelihood that the patient's back pain is caused by structural conditions in the back. Dr. Schubiner will then speak with patients for a 1 hour session in which he collects their medical history and discusses different possible causes of their back pain with them. This session will be conducted by phone, by HIPAA-compliant Zoom, or by another HIPAA-compliant videoconferencing technology in consultation with the OIT team at Dr. Schubiner's hospital.
Behavioral: Psychotherapy Treatment for Chronic Back Pain
Twice weekly 50 minute psychotherapy sessions for 4 weeks, plus an initial medical history session
No Intervention: Waitlist
Wait-listed patients will be asked not to change their treatment regime for the 4 weeks in between their two fMRI sessions. Wait-listed patients in the placebo injection arm will be offered the opportunity to receive the placebo treatment (optional). Waitlisted participants in the psychotherapy arm will be given a copy of Dr. Schubiner's book and free access to his online self-help program (optional to accept these).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief Pain Inventory-Short Form (BPI-SF)
Time Frame: At post-treatment fMRI session, approximately 1 month after randomization
1-week average pain intensity, 0 - 10 numerical rating scale, where a higher score indicates more pain.
At post-treatment fMRI session, approximately 1 month after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive Affect Scale Short Form (PANAS-SF)
Time Frame: At post-treatment fMRI session, approximately 1 month after randomization
Questionnaire to rate positive affect, scores range from 5 - 25, a higher score means stronger affect
At post-treatment fMRI session, approximately 1 month after randomization
PROMIS- Depression
Time Frame: At post-treatment fMRI session, approximately 1 month after randomization
Questionnaire measuring depression (8 items). Scores range from 8-32. A higher score indicates higher levels of depressive symptoms
At post-treatment fMRI session, approximately 1 month after randomization
Tampa Scale of Kinesiophobia (TSK)
Time Frame: At post-treatment fMRI session, approximately 1 month after randomization
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.
At post-treatment fMRI session, approximately 1 month after randomization
Pain Catastrophizing Questionnaire (PCS)
Time Frame: At post-treatment fMRI session, approximately 1 month after randomization
Questionnaire used to help quantify an individual's pain experience. Measured 0-52. A higher score means a higher level of catastrophizing.
At post-treatment fMRI session, approximately 1 month after randomization
Timeline Follow-Back Measure for Alcohol (TLFB)
Time Frame: At post-treatment fMRI session, approximately 1 month after randomization
Questionnaire used to assess daily drinking (number of drinks consumed over past two weeks)
At post-treatment fMRI session, approximately 1 month after randomization
Patient Global Impression of Change (PGIC)
Time Frame: At post-treatment fMRI session, approximately 1 month after randomization
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
At post-treatment fMRI session, approximately 1 month after randomization
Treatment Satisfaction Questionnaire
Time Frame: At post-treatment fMRI session, approximately 1 month after randomization
Post-treatment-only outcome measure depicting the patient's satisfaction with the treatment. Measured 0 - 100. A higher score means higher satisfaction with treatment/
At post-treatment fMRI session, approximately 1 month after randomization
Oswestry Disability Index
Time Frame: At post-treatment fMRI session, approximately 1 month after randomization
Back pain disability questionnaire measured on a scale of 0-100. A higher score indicates a higher severity of disability.
At post-treatment fMRI session, approximately 1 month after randomization
Negative Affect Scale Short Form (PANAS-SF)
Time Frame: At post-treatment fMRI session, approximately 1 month after randomization
Questionnaire to rate negative affect, scores range from 5 - 25, with a higher score meaning a stronger negative affect
At post-treatment fMRI session, approximately 1 month after randomization
PROMIS Anger
Time Frame: At post-treatment fMRI session, approximately 1 month after randomization
Questionnaire measuring anger (5 items) with a score range of 5-25. Higher scores indicate a higher severity of anger.
At post-treatment fMRI session, approximately 1 month after randomization
PROMIS Sleep
Time Frame: At post-treatment fMRI session, approximately 1 month after randomization
Questionnaire measuring sleep disturbance (8 items). Scores range from 8-40. Higher scores indicate higher levels of sleep disturbance
At post-treatment fMRI session, approximately 1 month after randomization
PROMIS Anxiety
Time Frame: At post-treatment fMRI session, approximately 1 month after randomization
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.
At post-treatment fMRI session, approximately 1 month after randomization
Timeline Follow-Back Measure for Opioid Use (TLFB)
Time Frame: At post-treatment fMRI session, approximately 1 month after randomization
Questionnaire used to assess daily opioid use (number of pills consumed over past two weeks)
At post-treatment fMRI session, approximately 1 month after randomization
Timeline Follow-Back Measure for Cannabis (TLFB)
Time Frame: At post-treatment fMRI session, approximately 1 month after randomization
Questionnaire used to assess daily cannabis use (number of grams consumed over past two weeks)
At post-treatment fMRI session, approximately 1 month after randomization

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Willingness to experience pain task
Time Frame: Pre- and post-treatment (5-7 weeks after baseline)
Pain auction measuring willingness to experience pain, adapted from Vlaev et al
Pre- and post-treatment (5-7 weeks after baseline)
Progressive ratio task
Time Frame: Pre- and post-treatment (5-7 weeks after baseline)
Participants click the mouse repeatedly to earn small amounts of money, to measure motivation
Pre- and post-treatment (5-7 weeks after baseline)
IL-1B
Time Frame: Pre- and post-treatment (5-7 weeks after baseline)
Marker of inflammation
Pre- and post-treatment (5-7 weeks after baseline)
IL-6
Time Frame: Pre- and post-treatment (5-7 weeks after baseline)
Marker of inflammation
Pre- and post-treatment (5-7 weeks after baseline)
fMRI
Time Frame: Pre- and post-treatment (5-7 weeks after baseline)
Patients will respond to different pain related tasks during an fMRI scan.
Pre- and post-treatment (5-7 weeks after baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Boulder

Collaborators

National Institutes of Health (NIH)
Radiological Society of North America
Psychophysiologic Disorders Society
Therapeutic Encouter Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2017

Primary Completion (Actual)

November 25, 2018

Study Completion (Actual)

November 26, 2019

Study Registration Dates

First Submitted

September 13, 2017

First Submitted That Met QC Criteria

September 25, 2017

First Posted (Actual)

September 26, 2017

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

February 24, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-0544

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Pain

Clinical Trials on Open-Label Placebo Treatment for Chronic Back Pain

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe