Chronic PainNCT03294148

Mind-body Treatments for Chronic Back Pain

A study testing Psychotherapy Treatment for Chronic Back Pain in people with Chronic Pain and Back Pain Lower Back Chronic, run by University of Colorado, Boulder at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 21 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Pain, Back Pain Lower Back Chronic, Back Pain, Low
What is being tested?: Psychotherapy Treatment for Chronic Back Pain
Type of treatment: Injection or infusion, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 151 participants
Where: 1 siteUnited States
Study dates: 7 Aug 2017to 26 Nov 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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).

Who cannot join

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).

Show all 13Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Colorado Boulder
Boulder, Colorado, 80309

Other trials in United States

About this study

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
Being tested: Open-Label Placebo Treatment for Chronic Back Pain, Psychotherapy Treatment for Chronic Back Pain
Keywords: Placebo, Back, Pain, Chronic, Mind-Body
Medical subject headings: Chronic Pain, Low Back Pain, Pain, Bronchiolitis Obliterans Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03294148
Study group	Role	What they receive
Placebo	Experimental	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. Receives: Other: Open-Label Placebo Treatment for Chronic Back Pain
Psychotherapy	Experimental	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. Receives: Behavioral: Psychotherapy Treatment for Chronic Back Pain
Waitlist	No intervention	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 being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (14)

Positive Affect Scale Short Form (PANAS-SF)
Questionnaire to rate positive affect, scores range from 5 - 25, a higher score means stronger affect
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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/
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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)
Measured: At post-treatment fMRI session, approximately 1 month after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Aug 201726 Nov 2019

First posted26 Sep 2017
Study start7 Aug 2017
Primary completion25 Nov 2018
Study completion26 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (67)Papers the sponsor has linked to this study.
Other trials for Chronic PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Outcomes assessor
Enrolment: 151 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03294148
Sponsor's protocol ID: 16-0544
Status last verified: Feb 2023
First submitted: 13 Sep 2017
Last updated: 22 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Annersten M, Willman A. Performing subcutaneous injections: a literature review. Worldviews Evid Based Nurs. 2005;2(3):122-30. doi: 10.1111/j.1741-6787.2005.00030.x.
PubMed 17040533
Ashar YK, Chang LJ, Wager TD. Brain Mechanisms of the Placebo Effect: An Affective Appraisal Account. Annu Rev Clin Psychol. 2017 May 8;13:73-98. doi: 10.1146/annurev-clinpsy-021815-093015. Epub 2017 Mar 27.
PubMed 28375723
Atlas LY, Bolger N, Lindquist MA, Wager TD. Brain mediators of predictive cue effects on perceived pain. J Neurosci. 2010 Sep 29;30(39):12964-77. doi: 10.1523/JNEUROSCI.0057-10.2010.
PubMed 20881115
Baliki MN, Petre B, Torbey S, Herrmann KM, Huang L, Schnitzer TJ, Fields HL, Apkarian AV. Corticostriatal functional connectivity predicts transition to chronic back pain. Nat Neurosci. 2012 Jul 1;15(8):1117-9. doi: 10.1038/nn.3153.
PubMed 22751038
Becker GM, DeGroot MH, Marschak J. Measuring utility by a single-response sequential method. Behav Sci. 1964 Jul;9(3):226-32. doi: 10.1002/bs.3830090304. No abstract available.
PubMed 5888778
Bicket MC, Gupta A, Brown CH 4th, Cohen SP. Epidural injections for spinal pain: a systematic review and meta-analysis evaluating the "control" injections in randomized controlled trials. Anesthesiology. 2013 Oct;119(4):907-31. doi: 10.1097/ALN.0b013e31829c2ddd.
PubMed 24195874
Blease C, Colloca L, Kaptchuk TJ. Are open-Label Placebos Ethical? Informed Consent and Ethical Equivocations. Bioethics. 2016 Jul;30(6):407-14. doi: 10.1111/bioe.12245. Epub 2016 Feb 3.
PubMed 26840547
Bushnell MC, Ceko M, Low LA. Cognitive and emotional control of pain and its disruption in chronic pain. Nat Rev Neurosci. 2013 Jul;14(7):502-11. doi: 10.1038/nrn3516. Epub 2013 May 30.
PubMed 23719569
Cherkin DC, Sherman KJ, Balderson BH, Cook AJ, Anderson ML, Hawkes RJ, Hansen KE, Turner JA. Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA. 2016 Mar 22-29;315(12):1240-9. doi: 10.1001/jama.2016.2323.
PubMed 27002445
Chou R, Qaseem A, Snow V, Casey D, Cross JT Jr, Shekelle P, Owens DK; Clinical Efficacy Assessment Subcommittee of the American College of Physicians; American College of Physicians; American Pain Society Low Back Pain Guidelines Panel. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007 Oct 2;147(7):478-91. doi: 10.7326/0003-4819-147-7-200710020-00006.
PubMed 17909209
Cohen SP, Argoff CE, Carragee EJ. Management of low back pain. BMJ. 2008 Dec 22;337:a2718. doi: 10.1136/bmj.a2718. No abstract available.
PubMed 19103627
Colloca L, Petrovic P, Wager TD, Ingvar M, Benedetti F. How the number of learning trials affects placebo and nocebo responses. Pain. 2010 Nov;151(2):430-439. doi: 10.1016/j.pain.2010.08.007.
PubMed 20817355
Delgado MR, Li J, Schiller D, Phelps EA. The role of the striatum in aversive learning and aversive prediction errors. Philos Trans R Soc Lond B Biol Sci. 2008 Dec 12;363(1511):3787-800. doi: 10.1098/rstb.2008.0161.
PubMed 18829426
Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.
PubMed 11132119
Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, DeLitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK; National Institutes of Health task force on research standards for chronic low back pain. Report of the National Institutes of Health task force on research standards for chronic low back pain. J Manipulative Physiol Ther. 2014 Sep;37(7):449-67. doi: 10.1016/j.jmpt.2014.07.006. Epub 2014 Aug 12.
PubMed 25127996

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mind-body Treatments for Chronic Back Pain
ClinicalTrials.gov ID: NCT03294148
Acronym / sponsor ID: 16-0544
Conditions: Chronic Pain, Back Pain Lower Back Chronic, Back Pain, Low
Keywords: Placebo, Back, Pain, Chronic, Mind-Body
Study type: Interventional
Recruitment status: Completed
Enrolment: 151 participants (actual)
Lead sponsor: University of Colorado, BoulderUniversity, hospital or other
Collaborators: Radiological Society of North America, National Institutes of Health (NIH), Psychophysiologic Disorders Society, Foundation for the Science of Therapeutic Encounter
Study start: 7 Aug 2017 (actual)
Primary completion: 25 Nov 2018 (actual)
Study completion: 26 Nov 2019 (actual)
First posted: 26 Sep 2017 (actual)
Results: Posted 22 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3
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.

Arm	Type	Receives
Placebo	Experimental	Other: Open-Label Placebo Treatment for Chronic Back PainThe 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	Experimental	Behavioral: Psychotherapy Treatment for Chronic Back PainPsychotherapy 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.
Waitlist	No intervention	–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).

Who may qualify

Ages: 21 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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).

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Open-Label Placebo Treatment for Chronic Back PainSubcutaneous injection of 1ml medical grade saline into the lower back.	Other	Placebo
Psychotherapy Treatment for Chronic Back PainTwice weekly 50 minute psychotherapy sessions for 4 weeks, plus an initial medical history session	Behavioural	Psychotherapy

Primary outcome

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.

14 secondary outcomes

Positive Affect Scale Short Form (PANAS-SF)
Time frame: At post-treatment fMRI session, approximately 1 month after randomization
PROMIS- Depression
Time frame: 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
Pain Catastrophizing Questionnaire (PCS)
Time frame: 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
Patient Global Impression of Change (PGIC)
Time frame: 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
Oswestry Disability Index
Time frame: 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
PROMIS Anger
Time frame: At post-treatment fMRI session, approximately 1 month after randomization
PROMIS Sleep
Time frame: At post-treatment fMRI session, approximately 1 month after randomization
PROMIS Anxiety
Time frame: 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
Timeline Follow-Back Measure for Cannabis (TLFB)
Time frame: At post-treatment fMRI session, approximately 1 month after randomization

Results and safety

Results posted to the registry on 22 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pain Reprocessing Therapy (PRT)	50	44
Placebo	51	44
Usual Care	50	47

Primary outcome: Brief Pain Inventory-Short Form (BPI-SF)

Time frame: At post-treatment fMRI session, approximately 1 month after randomization. Mean (Standard Deviation). Unit: units on a scale

Measure	Pain Reprocessing Therapy (PRT) n = 44	Placebo n = 44	Usual Care n = 47
Value	1.18 (1.24)	2.84 (1.64)	3.13 (1.45)

Population analysed: all available participants analyzed

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from enrollment through completion of the post-treatment fMRI session, an average of 1.5 months after enrollment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pain Reprocessing Therapy (PRT)	0 of 50 (0%)	0 of 50 (0%)	0 of 50
Placebo	0 of 51 (0%)	0 of 51 (0%)	0 of 51
Usual Care	0 of 50 (0%)	0 of 50 (0%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17040533Annersten M, Willman A. Performing subcutaneous injections: a literature review. Worldviews Evid Based Nurs. 2005;2(3):122-30. doi: 10.1111/j.1741-6787.2005.00030.x.
Background: PubMed 28375723Ashar YK, Chang LJ, Wager TD. Brain Mechanisms of the Placebo Effect: An Affective Appraisal Account. Annu Rev Clin Psychol. 2017 May 8;13:73-98. doi: 10.1146/annurev-clinpsy-021815-093015. Epub 2017 Mar 27.
Background: PubMed 20881115Atlas LY, Bolger N, Lindquist MA, Wager TD. Brain mediators of predictive cue effects on perceived pain. J Neurosci. 2010 Sep 29;30(39):12964-77. doi: 10.1523/JNEUROSCI.0057-10.2010.
Background: PubMed 22751038Baliki MN, Petre B, Torbey S, Herrmann KM, Huang L, Schnitzer TJ, Fields HL, Apkarian AV. Corticostriatal functional connectivity predicts transition to chronic back pain. Nat Neurosci. 2012 Jul 1;15(8):1117-9. doi: 10.1038/nn.3153.
Background: PubMed 5888778Becker GM, DeGroot MH, Marschak J. Measuring utility by a single-response sequential method. Behav Sci. 1964 Jul;9(3):226-32. doi: 10.1002/bs.3830090304. No abstract available.
Background: PubMed 24195874Bicket MC, Gupta A, Brown CH 4th, Cohen SP. Epidural injections for spinal pain: a systematic review and meta-analysis evaluating the "control" injections in randomized controlled trials. Anesthesiology. 2013 Oct;119(4):907-31. doi: 10.1097/ALN.0b013e31829c2ddd.
Background: PubMed 26840547Blease C, Colloca L, Kaptchuk TJ. Are open-Label Placebos Ethical? Informed Consent and Ethical Equivocations. Bioethics. 2016 Jul;30(6):407-14. doi: 10.1111/bioe.12245. Epub 2016 Feb 3.
Background: PubMed 23719569Bushnell MC, Ceko M, Low LA. Cognitive and emotional control of pain and its disruption in chronic pain. Nat Rev Neurosci. 2013 Jul;14(7):502-11. doi: 10.1038/nrn3516. Epub 2013 May 30.
Background: PubMed 27002445Cherkin DC, Sherman KJ, Balderson BH, Cook AJ, Anderson ML, Hawkes RJ, Hansen KE, Turner JA. Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA. 2016 Mar 22-29;315(12):1240-9. doi: 10.1001/jama.2016.2323.
Background: PubMed 17909209Chou R, Qaseem A, Snow V, Casey D, Cross JT Jr, Shekelle P, Owens DK; Clinical Efficacy Assessment Subcommittee of the American College of Physicians; American College of Physicians; American Pain Society Low Back Pain Guidelines Panel. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007 Oct 2;147(7):478-91. doi: 10.7326/0003-4819-147-7-200710020-00006.
Background: PubMed 19103627Cohen SP, Argoff CE, Carragee EJ. Management of low back pain. BMJ. 2008 Dec 22;337:a2718. doi: 10.1136/bmj.a2718. No abstract available.
Background: PubMed 20817355Colloca L, Petrovic P, Wager TD, Ingvar M, Benedetti F. How the number of learning trials affects placebo and nocebo responses. Pain. 2010 Nov;151(2):430-439. doi: 10.1016/j.pain.2010.08.007.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tor Wager principal investigator

University of Colorado, Boulder

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Psychotherapy Treatment for Chronic Back Pain in people with Chronic Pain and Back Pain Lower Back Chronic, run by University of Colorado, Boulder at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brief Pain Inventory-Short Form (BPI-SF) (time frame: At post-treatment fMRI session, approximately 1 month after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03294148, which also lists 67 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023; AzTrials last refreshed its copy on 31 Oct 2026.