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

  • STATUS
    Recruiting
  • End date
    Aug 21, 2024
  • participants needed
    300
  • sponsor
    Ajay Wasan, MD, Msc
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Updated on 21 March 2022
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Summary

This study will examine how the use of antidepressant, physical therapy, and combination of both affects pain, function, and depression outcomes in chronic low back pain patients.

Description

Approximately 20 million Americans are affected by chronic low back pain and negative affective states such as depression and anxiety. These negative states have all been associated with higher pain intensity, lower pain tolerance, greater use of pain medication, poor pain treatment responses, and higher levels of psychiatric comorbidity among low back pain patients. To improve these outcomes for those who suffer from low back pain, it is important to implement multiple methods with a focus in treating negative affect for pain management rather than using opioids alone.

Antidepressant (AD) and fear avoidance-based physical therapy (EFAR) have individually shown to be promising methods for pain management. In this study, AD, EFAR, and the combination therapy of the two treatments will be explored and implemented to investigate their effectiveness in improving pain, function, depression, and anxiety. The key innovation is testing a new and effective multimodal treatment that can help manage pain, as well as address negative affect.

Details
Condition Chronic Low Back Pain, Negative Affectivity
Treatment antidepressant, Enhanced Fear Avoidance Rehabilitation
Clinical Study IdentifierNCT04747314
SponsorAjay Wasan, MD, Msc
Last Modified on21 March 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Ages 18-75
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), participants 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. The investigators 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, 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. Women of childbearing potential will all submit a urine sample pregnancy testing at enrollment
Not fluent in English and/or not able to complete the questionnaires
Clear my responses
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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