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Mind-body Treatments for Chronic Back Pain

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Open-Label Placebo Treatment for Chronic Back Pain
Psychotherapy Treatment for Chronic Back Pain
Sponsored by
University of Colorado, Boulder
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Placebo, Back, Pain, Chronic, Mind-Body

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Colorado Boulder

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Placebo

Psychotherapy

Waitlist

Arm Description

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.

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.

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).

Outcomes

Primary Outcome Measures

Brief Pain Inventory-Short Form (BPI-SF)
1-week average pain intensity, 0 - 10 numerical rating scale, where a higher score indicates more pain.

Secondary Outcome Measures

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

Full Information

First Posted
September 13, 2017
Last Updated
February 24, 2023
Sponsor
University of Colorado, Boulder
Collaborators
Radiological Society of North America, National Institutes of Health (NIH), Psychophysiologic Disorders Society, Therapeutic Encouter Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03294148
Brief Title
Mind-body Treatments for Chronic Back Pain
Official Title
Mind-body Treatments for Chronic Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 7, 2017 (Actual)
Primary Completion Date
November 25, 2018 (Actual)
Study Completion Date
November 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Colorado, Boulder
Collaborators
Radiological Society of North America, National Institutes of Health (NIH), Psychophysiologic Disorders Society, Therapeutic Encouter Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Back Pain Lower Back Chronic, Back Pain, Low
Keywords
Placebo, Back, Pain, Chronic, Mind-Body

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Researchers will not know which treatment the participants will be receiving (placebo or psychotherapy).
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
Psychotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Open-Label Placebo Treatment for Chronic Back Pain
Intervention Description
Subcutaneous injection of 1ml medical grade saline into the lower back.
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy Treatment for Chronic Back Pain
Intervention Description
Twice weekly 50 minute psychotherapy sessions for 4 weeks, plus an initial medical history session
Primary Outcome Measure Information:
Title
Brief Pain Inventory-Short Form (BPI-SF)
Description
1-week average pain intensity, 0 - 10 numerical rating scale, where a higher score indicates more pain.
Time Frame
At post-treatment fMRI session, approximately 1 month after randomization
Secondary Outcome Measure Information:
Title
Positive Affect Scale Short Form (PANAS-SF)
Description
Questionnaire to rate positive affect, scores range from 5 - 25, a higher score means stronger affect
Time Frame
At post-treatment fMRI session, approximately 1 month after randomization
Title
PROMIS- Depression
Description
Questionnaire measuring depression (8 items). Scores range from 8-32. A higher score indicates higher levels of depressive symptoms
Time Frame
At post-treatment fMRI session, approximately 1 month after randomization
Title
Tampa Scale of Kinesiophobia (TSK)
Description
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.
Time Frame
At post-treatment fMRI session, approximately 1 month after randomization
Title
Pain Catastrophizing Questionnaire (PCS)
Description
Questionnaire used to help quantify an individual's pain experience. Measured 0-52. A higher score means a higher level of catastrophizing.
Time Frame
At post-treatment fMRI session, approximately 1 month after randomization
Title
Timeline Follow-Back Measure for Alcohol (TLFB)
Description
Questionnaire used to assess daily drinking (number of drinks consumed over past two weeks)
Time Frame
At post-treatment fMRI session, approximately 1 month after randomization
Title
Patient Global Impression of Change (PGIC)
Description
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
Time Frame
At post-treatment fMRI session, approximately 1 month after randomization
Title
Treatment Satisfaction Questionnaire
Description
Post-treatment-only outcome measure depicting the patient's satisfaction with the treatment. Measured 0 - 100. A higher score means higher satisfaction with treatment/
Time Frame
At post-treatment fMRI session, approximately 1 month after randomization
Title
Oswestry Disability Index
Description
Back pain disability questionnaire measured on a scale of 0-100. A higher score indicates a higher severity of disability.
Time Frame
At post-treatment fMRI session, approximately 1 month after randomization
Title
Negative Affect Scale Short Form (PANAS-SF)
Description
Questionnaire to rate negative affect, scores range from 5 - 25, with a higher score meaning a stronger negative affect
Time Frame
At post-treatment fMRI session, approximately 1 month after randomization
Title
PROMIS Anger
Description
Questionnaire measuring anger (5 items) with a score range of 5-25. Higher scores indicate a higher severity of anger.
Time Frame
At post-treatment fMRI session, approximately 1 month after randomization
Title
PROMIS Sleep
Description
Questionnaire measuring sleep disturbance (8 items). Scores range from 8-40. Higher scores indicate higher levels of sleep disturbance
Time Frame
At post-treatment fMRI session, approximately 1 month after randomization
Title
PROMIS Anxiety
Description
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.
Time Frame
At post-treatment fMRI session, approximately 1 month after randomization
Title
Timeline Follow-Back Measure for Opioid Use (TLFB)
Description
Questionnaire used to assess daily opioid use (number of pills consumed over past two weeks)
Time Frame
At post-treatment fMRI session, approximately 1 month after randomization
Title
Timeline Follow-Back Measure for Cannabis (TLFB)
Description
Questionnaire used to assess daily cannabis use (number of grams consumed over past two weeks)
Time Frame
At post-treatment fMRI session, approximately 1 month after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tor Wager
Organizational Affiliation
University of Colorado, Boulder
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Boulder
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80309
Country
United States

12. IPD Sharing Statement

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