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          Grants & Funding: The NIAMS Extramural Program
          Clinical Trials in the Spotlight
          Proof of Concept Study to Treat Negative Affect in Chronic Low Back Pain








Proof of Concept Study to Treat Negative Affect in Chronic Low Back Pain FacebookEmailPrintFacebookEmail     
    Clinical Trials in the Spotlight Main Page

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) supports a range of clinical trials studying new and existing interventions for prevention and treatment of arthritis, musculoskeletal, and skin diseases.  Investigators supported by the NIAMS need your help finding individuals to participate in clinical trials.  Participating in clinical trials allows you to play an active role as a volunteer in research and contribute to generating new knowledge about the disease/condition, and potentially future treatments.  The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible.

Study Description

This study addresses the need for better evidence-based pain treatment for patients with chronic low back pain (CLBP) who have co-occurring negative affective disorders, such as major depression with anxious features. The CLBP subgroup with comorbid depression or anxiety disorders (commonly termed, high negative affect) is approximately 20-30% of the 50 million adults with CLBP in the United States. This subgroup is particularly refractory to pain treatment and is in desperate need of better non-opioid, comprehensive pain treatment options. Patients with CLBP and high levels of negative affect (NA) suffer higher levels of pain and have worse disability and function. Due to these factors, they have been prescribed opioids more frequently and misuse opioids at a much greater rate (40-60% rates of non-adherence), which is related to self-medication of depression and anxiety by taking extra opioids. Poor pain management in patients with high NA is due in part to a lack of more effective evidence-based treatment options to improve pain, depression, anxiety, and function, and prevent opioid misuse.

To address the unmet needs of CLBP patients with high negative affect, the study team proposes to test in a randomized trial if the combination of AD+EFAR is more effective than each treatment alone to improve pain, function, depression, and prevent opioid misuse (3- arms, in 300 subjects). To better identify responders to components of the intervention (AD or EFAR), the study team will use an adaptive design whereby non-responders to each treatment are re-randomized to receive the other treatment. This multimodal, combination approach of pharmacotherapy +behavioral therapy is novel to the field and has the potential to shift current treatment paradigms.

**ELIGIBILITY CRITERIA:**

Ages Eligible for Study:             18 Years to 75 Years   (Adult, Older Adult)

Sexes Eligible for Study:           All

Accepts Healthy Volunteers:  No

**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**Study Design:**

Allocation:       Randomized

Intervention Model: Sequential Assignment

Masking: None (Open Label)

Primary Purpose: Treatment

**Study Location(s):**

BWH Pain Management Center, Chestnut Hill, Massachusetts, United States, 02467

Mayo Clinic, Rochester, Minnesota, United States, 55905

UPMC Pain Medicine At Centre Commons, Pittsburgh, Pennsylvania, United States, 15206

**Study Website:**

https://clinicaltrials.gov/ct2/show/NCT04747314?term=NCT04747314&draw=2&rank=1


Last Updated: June 2021


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