CompletedNCT03294148Updated Mar 22, 2023Results posted

Mind-body Treatments for Chronic Back Pain

An interventional study of Open-Label Placebo Treatment for Chronic Back Pain and Psychotherapy Treatment for Chronic Back Pain in Chronic Pain, Back Pain Lower Back Chronic and Back Pain, Low, sponsored by University of Colorado, Boulder. Completed at 1 site in United States. Open to participants aged 21 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-22.

Sponsored by University of Colorado, Boulder · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 151
Allocation: Randomized
Ages: 21 Years to 70 Years
Sex: All

Study 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 studied

Chronic Pain
Back Pain Lower Back Chronic
Back Pain, Low

Browse trials for

Keywords

Placebo
Back
Pain
Chronic
Mind-Body

Who can participate

Ages eligible: 21 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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 design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 151 participants (actual)

Study arms

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
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
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).

Interventions

OtherOpen-Label Placebo Treatment for Chronic Back Pain
Subcutaneous injection of 1ml medical grade saline into the lower back.
BehavioralPsychotherapy Treatment for Chronic Back Pain
Twice weekly 50 minute psychotherapy sessions for 4 weeks, plus an initial medical history session

What researchers measure

Primary outcomes

Brief Pain Inventory-Short Form (BPI-SF)
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 outcomes

Positive Affect Scale Short Form (PANAS-SF)
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
PROMIS- Depression
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
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.
Time frame: At post-treatment fMRI session, approximately 1 month after randomization
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.
Time frame: At post-treatment fMRI session, approximately 1 month after randomization
Timeline Follow-Back Measure for Alcohol (TLFB)
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
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
Time frame: At post-treatment fMRI session, approximately 1 month after randomization
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/
Time frame: At post-treatment fMRI session, approximately 1 month after randomization
Oswestry Disability Index
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
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
Time frame: At post-treatment fMRI session, approximately 1 month after randomization
PROMIS Anger
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
PROMIS Sleep
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
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.
Time frame: At post-treatment fMRI session, approximately 1 month after randomization
Timeline Follow-Back Measure for Opioid Use (TLFB)
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
Timeline Follow-Back Measure for Cannabis (TLFB)
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

Results

Posted Mar 22, 2023

Participant flow

Participant flow — Overall Study
Milestone	Pain Reprocessing Therapy (PRT)	Placebo	Usual Care
Started	50	51	50
Completed	44	44	47
Not completed	6	7	3

Outcome measures

PrimaryBrief Pain Inventory-Short Form (BPI-SF)

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
Reported as:: Mean · units on a scale

Brief Pain Inventory-Short Form (BPI-SF)
units on a scale	Pain Reprocessing Therapy (PRT)	Placebo	Usual Care
Brief Pain Inventory-Short Form (BPI-SF)	1.18 ± 1.24	2.84 ± 1.64	3.13 ± 1.45

SecondaryPositive Affect Scale Short Form (PANAS-SF)

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
Reported as:: Mean · score on a scale

Positive Affect Scale Short Form (PANAS-SF)
score on a scale	Pain Reprocessing Therapy (PRT)	Placebo	Usual Care
Positive Affect Scale Short Form (PANAS-SF)	17.89 ± 3.38	15.20 ± 5.60	14.98 ± 3.50

SecondaryPROMIS- Depression

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
Reported as:: Mean · score on a scale

PROMIS- Depression
score on a scale	Pain Reprocessing Therapy (PRT)	Placebo	Usual Care
PROMIS- Depression	12.23 ± 4.94	11.75 ± 4.05	11.81 ± 4.45

SecondaryTampa 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.

Time frame:: At post-treatment fMRI session, approximately 1 month after randomization
Reported as:: Mean · score on a scale

Tampa Scale of Kinesiophobia (TSK)
score on a scale	Pain Reprocessing Therapy (PRT)	Placebo	Usual Care
Tampa Scale of Kinesiophobia (TSK)	16.41 ± 5.37	22.16 ± 4.94	22.51 ± 6.30

SecondaryPain 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.

Time frame:: At post-treatment fMRI session, approximately 1 month after randomization
Reported as:: Mean · score on a scale

Pain Catastrophizing Questionnaire (PCS)
score on a scale	Pain Reprocessing Therapy (PRT)	Placebo	Usual Care
Pain Catastrophizing Questionnaire (PCS)	8.30 ± 3.04	7.70 ± 2.44	8.19 ± 2.75

SecondaryTimeline Follow-Back Measure for Alcohol (TLFB)

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
Reported as:: Mean · Drinks

Timeline Follow-Back Measure for Alcohol (TLFB)
Drinks	Pain Reprocessing Therapy (PRT)	Placebo	Usual Care
Timeline Follow-Back Measure for Alcohol (TLFB)	11.63 ± 10.83	12.88 ± 14.30	8.02 ± 10.63

SecondaryPatient 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

Time frame:: At post-treatment fMRI session, approximately 1 month after randomization
Reported as:: Mean · score on a scale

Patient Global Impression of Change (PGIC)
score on a scale	Pain Reprocessing Therapy (PRT)	Placebo	Usual Care
Patient Global Impression of Change (PGIC)	6.14 ± 0.88	3.61 ± 1.62	2.06 ± 1.45

SecondaryTreatment 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/

Time frame:: At post-treatment fMRI session, approximately 1 month after randomization
Reported as:: Mean · score on a scale

Treatment Satisfaction Questionnaire
score on a scale	Pain Reprocessing Therapy (PRT)	Placebo	Usual Care
Treatment Satisfaction Questionnaire	92.40 ± 8.01	57.61 ± 23.05	36.86 ± 23.01

SecondaryOswestry Disability Index

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
Reported as:: Mean · score on a scale

Oswestry Disability Index
score on a scale	Pain Reprocessing Therapy (PRT)	Placebo	Usual Care
Oswestry Disability Index	10.14 ± 10.63	19.00 ± 11.07	20.68 ± 10.68

SecondaryNegative 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

Time frame:: At post-treatment fMRI session, approximately 1 month after randomization
Reported as:: Mean · score on a scale

Negative Affect Scale Short Form (PANAS-SF)
score on a scale	Pain Reprocessing Therapy (PRT)	Placebo	Usual Care
Negative Affect Scale Short Form (PANAS-SF)	8.30 ± 3.04	7.70 ± 2.44	8.19 ± 2.75

SecondaryPROMIS Anger

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
Reported as:: Mean · score on a scale

PROMIS Anger
score on a scale	Pain Reprocessing Therapy (PRT)	Placebo	Usual Care
PROMIS Anger	9.52 ± 3.91	9.89 ± 3.81	10.45 ± 3.86

SecondaryPROMIS Sleep

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
Reported as:: Mean · score on a scale

PROMIS Sleep
score on a scale	Pain Reprocessing Therapy (PRT)	Placebo	Usual Care
PROMIS Sleep	17.73 ± 6.75	20.50 ± 6.17	20.89 ± 6.02

SecondaryPROMIS 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.

Time frame:: At post-treatment fMRI session, approximately 1 month after randomization
Reported as:: Mean · score on a scale

PROMIS Anxiety
score on a scale	Pain Reprocessing Therapy (PRT)	Placebo	Usual Care
PROMIS Anxiety	15.02 ± 6.16	13.89 ± 5.78	14.11 ± 6.99

SecondaryTimeline Follow-Back Measure for Opioid Use (TLFB)

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
Reported as:: Mean · Opioid pills

Timeline Follow-Back Measure for Opioid Use (TLFB)
Opioid pills	Pain Reprocessing Therapy (PRT)	Placebo	Usual Care
Timeline Follow-Back Measure for Opioid Use (TLFB)	1.29 ± 4.50	0.36 ± 2.11	1.77 ± 8.99

SecondaryTimeline Follow-Back Measure for Cannabis (TLFB)

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
Reported as:: Mean · Grams of cannabis

Timeline Follow-Back Measure for Cannabis (TLFB)
Grams of cannabis	Pain Reprocessing Therapy (PRT)	Placebo	Usual Care
Timeline Follow-Back Measure for Cannabis (TLFB)	6.76 ± 25.32	3.31 ± 6.72	1.49 ± 3.20

Adverse events

Collected over Adverse events were collected from enrollment through completion of the post-treatment fMRI session, an average of 1.5 months after enrollment.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Pain Reprocessing Therapy (PRT)	0/50 (0%)	0/50 (0%)	0/50 (0%)
Placebo	0/51 (0%)	0/51 (0%)	0/51 (0%)
Usual Care	0/50 (0%)	0/50 (0%)	0/50 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Pain Reprocessing Therapy (PRT)	Placebo	Usual Care	Total
Mean	42.6 ± 16.2	39.4 ± 14.9	41.3 ± 15.9	41.1 ± 15.6

Sex: Female, Male
Sex: Female, Male(Participants)	Pain Reprocessing Therapy (PRT)	Placebo	Usual Care	Total
Female	29	25	27	81
Male	21	26	23	70

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Pain Reprocessing Therapy (PRT)	Placebo	Usual Care	Total
Hispanic or Latino	0	2	2	4
Not Hispanic or Latino	50	49	48	147
Unknown or Not Reported	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Pain Reprocessing Therapy (PRT)	Placebo	Usual Care	Total
American Indian or Alaska Native	0	0	1	1
Asian	3	2	0	5
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	0	2	1	3
White	46	45	43	134
More than one race	1	2	5	8
Unknown or Not Reported	0	0	0	0

Study locations

1 site

University of Colorado Boulder
Boulder, Colorado 80309, United States

References and documents

Publications

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Study documents

Protocol and statistical analysis plan · Sep 5, 2018
Informed consent form · Jul 23, 2018
Informed consent form · Jul 23, 2018
Informed consent form · Jul 23, 2018

Documents are hosted by the registry — open the source record to download them.

Registry details

Key details

Study ID: NCT03294148
Lead sponsor: University of Colorado, Boulder
Collaborators: Radiological Society of North America, National Institutes of Health (NIH), Psychophysiologic Disorders Society, Foundation for the Science of Therapeutic Encounter
Responsible party: Jonathan Ashar (Graduate student under the supervision of PI Wager, University of Colorado, Boulder) — Principal investigator
First posted: Sep 26, 2017
Start date: Aug 7, 2017
Primary completion: Nov 25, 2018
Completion: Nov 26, 2019
Results posted: Mar 22, 2023
Last update: Mar 22, 2023

Study contacts

Tor Wager

principal investigator · University of Colorado, Boulder

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

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