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Mind-body Treatments for Chronic Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03294148
Recruitment Status : Completed
First Posted : September 26, 2017
Results First Posted : March 22, 2023
Last Update Posted : March 22, 2023
Sponsor:
Collaborators:
Radiological Society of North America
National Institutes of Health (NIH)
Psychophysiologic Disorders Society
Therapeutic Encouter Foundation
Information provided by (Responsible Party):
Jonathan Ashar, University of Colorado, Boulder

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease Intervention/treatment Phase
Chronic Pain Back Pain Lower Back Chronic Back Pain, Low Other: Open-Label Placebo Treatment for Chronic Back Pain Behavioral: Psychotherapy Treatment for Chronic Back Pain Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
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)
Masking Description: Researchers will not know which treatment the participants will be receiving (placebo or psychotherapy).
Primary Purpose: Treatment
Official Title: Mind-body Treatments for Chronic Back Pain
Actual Study Start Date : August 7, 2017
Actual Primary Completion Date : November 25, 2018
Actual Study Completion Date : November 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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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).


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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)

  6. 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

  7. 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/

  8. 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.

  9. 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

  10. 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.

  11. 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

  12. 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.

  13. 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)

  14. 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)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294148


Locations
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United States, Colorado
University of Colorado Boulder
Boulder, Colorado, United States, 80309
Sponsors and Collaborators
University of Colorado, Boulder
Radiological Society of North America
National Institutes of Health (NIH)
Psychophysiologic Disorders Society
Therapeutic Encouter Foundation
Investigators
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Principal Investigator: Tor Wager University of Colorado, Boulder
  Study Documents (Full-Text)

Documents provided by Jonathan Ashar, University of Colorado, Boulder:
Study Protocol and Statistical Analysis Plan  [PDF] September 5, 2018
Informed Consent Form: Placebo  [PDF] July 23, 2018
Informed Consent Form: Control  [PDF] July 23, 2018
Informed Consent Form: Psychotherapy  [PDF] July 23, 2018

More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jonathan Ashar, Graduate student under the supervision of PI Wager, University of Colorado, Boulder
ClinicalTrials.gov Identifier: NCT03294148    
Other Study ID Numbers: 16-0544
First Posted: September 26, 2017    Key Record Dates
Results First Posted: March 22, 2023
Last Update Posted: March 22, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jonathan Ashar, University of Colorado, Boulder:
Placebo
Back
Pain
Chronic
Mind-Body
Additional relevant MeSH terms:
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Back Pain
Chronic Pain
Low Back Pain
Pain
Neurologic Manifestations