Treating Negative Affect in Low Back Pain Patients (TNA-LBP)

Overview

About this study

The purpose of this study is to compare the effectiveness of combination therapy with antidepressants (AD), fear avoidance rehabilitation (EFAR) AD+EFAR vs. each treatment alone to improve pain, self-reported function, depression, and anxiety in patients with chronic low back pain and high negative affect.

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Male or female, aged 18-75 years of age.
  • Pain duration > 6 months.
  • Must meet the minimum criteria for cognitive function using the PROMIS 2-item cognitive screener (> 3).
  • Average pain score of > 3/10, with low back pain being the primary pain site.
  • CLBP meeting Quebec Task Force Classification System categories I-III (from axial pain only to pain radiating beyond the knee without neurological signs). Constant radicular pain associated with sensory loss is highly treatment resistant without surgery.
  • Evidence of a prior lumbar spine X-ray to rule out red flags, such as infection, tumor, or fracture.
  • Must meet criteria for high negative affect at 1st study visit: at least 5 on the PHQ-4 (also called the PHQ-2 + GAD-2). Scores above this level are highly associated with having a co-morbid major depression or generalized anxiety disorder diagnosis.
  • Having accessible electronic medical records from UPMC, Brigham and Women’s Hospital, or Mayo Clinic, Rochester.
  • For those taking opioids (the opioid subgroup), they must be prescribed opioids currently for at least 3 consecutive months prior to enrollment. Patients must be on opioids for a minimum of three months, taking them on a daily basis or intermittently during the week. We will include those on strong opioids, such as oxycodone and weak opioids, such as tramadol.
  • Subject must agree that opioids cannot be increased during the study.
  • For those taking opioids (the opioid subgroup), no active substance use disorder in the past year as determined by the PI with the use of the Tobacco, Alcohol, Prescription Medications, and Other Substance Tool (TAPS) and a urine toxicology screen. The exceptions are tobacco, medical marijuana use in Pennsylvania or Minnesota, recreational or medical marijuana in the Boston site, or mild prescription opioid use disorder such as opioid misuse.
  • No acute suicidality or history of major thought disorder (such as mania or psychosis). This will be assessed at study entry which will also include a review of history in EPIC/EMR.
  • Must possess a mobile device or tablet that can send and receive text messages and access the internet.

Exclusion Criteria:

  • Back surgery within the past six months.
  • Active worker’s compensation or litigation claims.
  • New pain and/or psychiatric treatments within 2 weeks of enrollment.
  • Intent to add new or increase pain treatments during the study period, such as back surgery, nerve block procedures, or medications.
  • Intent to add new psychiatric treatments during the first 4 months of the study.
  • Any clinically unstable systemic illness that is judged to interfere with the trial.
  • History of cardiac, nervous system, or respiratory disease that, in the investigator’s judgment, precludes participation in the study because of a heightened potential for respiratory depression.
  • Non-ambulatory status.
  • Pregnancy or the intent to become pregnant during the study. Childbearing women will all submit a urine pregnancy test at enrollment.
  • Not fluent in English and/or not able to complete the questionnaires.

Eligibility last updated 8/24/21. Questions regarding updates should be directed to the study team contact.

 

 

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

William Hooten, M.D.

Open for enrollment

Contact information:

Anita Stoltenberg R.R.T., L.R.T.

(507) 422-0582

Stoltenberg.Anita@mayo.edu

More information

Publications

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