Treating Negative Affect in Low Back Pain Patients (TNA-LBP)
Chronic Low Back Pain, Negative Affectivity
![Ajay Wasan, MD, Msc](https://trials-media.s3.amazonaws.com/orgs/ajay-wasan-md-msc.jpeg)
About this trial
This is an interventional treatment trial for Chronic Low Back Pain focused on measuring chronic pain, low back pain, fibromyalgia, mood, affect, depression, anxiety, opioid use
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
- 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
Sites / Locations
- BWH Pain Management CenterRecruiting
- Mayo ClinicRecruiting
- UPMC Pain Medicine At Centre CommonsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
Antidepressant (AD)
Enhanced Fear Avoidance Rehabilitation (EFAR)
Antidepressant (AD) + Enhanced Fear Avoidance Rehabilitation (EFAR)
AD -> EFAR
EFAR -> AD
Subjects will be randomly assigned to receive the antidepressant medication for 4 months under the care of a nurse practitioner and psychiatrist, in addition to their current opioid prescription and weaning guidelines, if applicable. Dosage change and side effects are mitigated by check-in visits (virtually or in-person) every 4 weeks. Non-responders determined at the end of 4 months will be re-randomized to continue receiving AD or EFAR for another 4 months.
Subjects will be randomly assigned to receive 8 1-hour physical therapy sessions, pain education, and motivational messaging via Vivify app for 4 months, in addition to their current opioid prescription and weaning guidelines, if applicable. Trained physical/occupational therapists will determine the activities as part of the treatment. Non-responders determined at the end of 4 months will be re-randomized to continue receiving EFAR or AD for another 4 months.
Subjects will receive a combination of antidepressant medication and physical therapy for 8 months, in addition to their current opioid prescription and weaning guidelines, if applicable. No re-randomization will be done in this treatment group.
Subjects will be randomly assigned to receive the antidepressant medication for 4 months under the care of a nurse practitioner and psychiatrist, in addition to their current opioid prescription and weaning guidelines, if applicable. Dosage change and side effects are mitigated by check-in visits (virtually or in-person) every 4 weeks. Non-responders determined at the end of 4 months will be re-randomized to continue receiving AD or EFAR for another 4 months. Those re-randomized to receive EFAR for another 4 months will receive a combination of antidepressant medication and physical therapy, in addition to their current opioid prescription and weaning guidelines, if applicable.
Subjects will be randomly assigned to receive 8 1-hour physical therapy sessions, pain education, and motivational messaging via Vivify app for 4 months, in addition to their current opioid prescription and weaning guidelines, if applicable. Trained physical/occupational therapists will determine the activities as part of the treatment. Non-responders determined at the end of 4 months will be re-randomized to continue receiving EFAR or AD for another 4 months. Those re-randomized to receive AD for another 4 months will be under the care of a nurse practitioner and psychiatrist, in addition to their current opioid prescription and weaning guidelines, if applicable. Dosage change and side effects are mitigated by check-in visits (virtually or in-person) every 4 weeks.