Mind-body Treatments for Chronic Back Pain

Chronic Pain Clinical Trial

Official title:

Mind-body Treatments for Chronic Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03294148
• Other study ID #: 16-0544
• Status: Completed
• Phase: N/A
• Start date: August 7, 2017
• Est. completion date: November 26, 2019

Study information

• Verified date: February 2023
• Source: University of Colorado, Boulder
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: November 26, 2019
• Est. primary completion date: November 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Open-Label Placebo Treatment for Chronic Back Pain
Subcutaneous injection of 1ml medical grade saline into the lower back.

Behavioral:
• Psychotherapy Treatment for Chronic Back Pain
Twice weekly 50 minute psychotherapy sessions for 4 weeks, plus an initial medical history session

Locations

Country	Name	City	State
United States	University of Colorado Boulder	Boulder	Colorado

Sponsors (5)

Lead Sponsor	Collaborator
University of Colorado, Boulder	National Institutes of Health (NIH), Psychophysiologic Disorders Society, Radiological Society of North America, Therapeutic Encouter Foundation

Country where clinical trial is conducted

United States, 

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* Note: There are 65 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief Pain Inventory-Short Form (BPI-SF)	1-week average pain intensity, 0 - 10 numerical rating scale, where a higher score indicates more pain.	At post-treatment fMRI session, approximately 1 month after randomization
Secondary	Positive Affect Scale Short Form (PANAS-SF)	Questionnaire to rate positive affect, scores range from 5 - 25, a higher score means stronger affect	At post-treatment fMRI session, approximately 1 month after randomization
Secondary	PROMIS- Depression	Questionnaire measuring depression (8 items). Scores range from 8-32. A higher score indicates higher levels of depressive symptoms	At post-treatment fMRI session, approximately 1 month after randomization
Secondary	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.	At post-treatment fMRI session, approximately 1 month after randomization
Secondary	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.	At post-treatment fMRI session, approximately 1 month after randomization
Secondary	Timeline Follow-Back Measure for Alcohol (TLFB)	Questionnaire used to assess daily drinking (number of drinks consumed over past two weeks)	At post-treatment fMRI session, approximately 1 month after randomization
Secondary	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	At post-treatment fMRI session, approximately 1 month after randomization
Secondary	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/	At post-treatment fMRI session, approximately 1 month after randomization
Secondary	Oswestry Disability Index	Back pain disability questionnaire measured on a scale of 0-100. A higher score indicates a higher severity of disability.	At post-treatment fMRI session, approximately 1 month after randomization
Secondary	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	At post-treatment fMRI session, approximately 1 month after randomization
Secondary	PROMIS Anger	Questionnaire measuring anger (5 items) with a score range of 5-25. Higher scores indicate a higher severity of anger.	At post-treatment fMRI session, approximately 1 month after randomization
Secondary	PROMIS Sleep	Questionnaire measuring sleep disturbance (8 items). Scores range from 8-40. Higher scores indicate higher levels of sleep disturbance	At post-treatment fMRI session, approximately 1 month after randomization
Secondary	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.	At post-treatment fMRI session, approximately 1 month after randomization
Secondary	Timeline Follow-Back Measure for Opioid Use (TLFB)	Questionnaire used to assess daily opioid use (number of pills consumed over past two weeks)	At post-treatment fMRI session, approximately 1 month after randomization
Secondary	Timeline Follow-Back Measure for Cannabis (TLFB)	Questionnaire used to assess daily cannabis use (number of grams consumed over past two weeks)	At post-treatment fMRI session, approximately 1 month after randomization