Clinical trial NCT04747314: Treating Negative Affect in Low Back Pain Patients
Official title: Proof of Concept Study to Treat Negative Affect in Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Chronic Low Back Pain
Negative Affectivity
Keywords: chronic pain
low back pain
fibromyalgia
mood
affect
depression
anxiety
opioid use
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: Mayo Clinic
name: Mass General Brigham
First posted: 2021-02-10
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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
* In the investigator's judgment, evidence of healthcare seeking for low back pain.
* 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

Primary outcomes:
measure: Change from Baseline Physical Function at 4 months using PROMIS (combined with pain intensity to form a combined measure)
timeFrame: Baseline vs. 4 months
measure: Change from Baseline Pain Intensity at 4 months using PROMIS (combined with function to form a combined measure).
timeFrame: Baseline vs. 4 months
measure: Change from Baseline Depression at 4 months using PROMIS
timeFrame: Baseline vs. 4 months
Secondary outcomes:
measure: Change from Baseline Pain Interference at 4 months using PROMIS
timeFrame: Baseline vs. 4 months
measure: Change from Baseline Anxiety at 4 months using PROMIS
timeFrame: Baseline vs. 4 months
measure: Change from Baseline Sleep at 4 months using PROMIS
timeFrame: Baseline vs. 4 months
measure: Change from Baseline Opioid Cravings at 4 months using the Craving Index
timeFrame: Baseline vs. 4 months
measure: Change from Baseline Subject's Perception of Change from Treatment at 4 months using Patient Global Impression of Change (PGIC)
timeFrame: Baseline vs. 4 months
measure: Change from Baseline Opioid Misuse at 4 months using Current Opioid Misuse Measure
timeFrame: Baseline vs. 4 months
Other outcomes:
Locations:
city: Chestnut Hill
country: United States
facility: BWH Pain Management Center
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Pittsburgh
country: United States
facility: UPMC Pain Medicine At Centre Commons
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Ajay Wasan, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: