Status:
COMPLETED
Mind-body Treatments for Chronic Back Pain
Lead Sponsor:
University of Colorado, Boulder
Collaborating Sponsors:
Radiological Society of North America
National Institutes of Health (NIH)
Conditions:
Chronic Pain
Back Pain Lower Back Chronic
Eligibility:
All Genders
21-70 years
Phase:
NA
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,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 26 2019
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT03294148
Start Date
August 7 2017
End Date
November 26 2019
Last Update
March 22 2023
Active Locations (1)
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1
University of Colorado Boulder
Boulder, Colorado, United States, 80309