Treating Negative Affect in Low Back Pain Patients

Chronic Low Back Pain Clinical Trial

— TNA-LBP  

Official title:

Proof of Concept Study to Treat Negative Affect in Chronic Low Back Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04747314
• Other study ID #: PRO19100026
• Secondary ID: UG3AR076568
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: March 31, 2021
• Est. completion date: April 30, 2026

Study information

• Verified date: February 2024
• Source: University of Pittsburgh
• Contact: Bhagyasri Jain Dharmaraj, BPharm
• Phone: (412)-665-2904
• Email: bhd20[@]pitt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: April 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain
• Negative Affectivity

Intervention

Drug:
• Antidepressant
The antidepressant treatment utilizes antidepressant medication to improve pain, function, and depression outcomes. The Antidepressant Treatment History Form (ATHF) will be used to assess adequacy of any prior antidepressant medication treatment and to assist the decision regarding which antidepressant to start. A medication flowchart will help serve as a guideline throughout the drug selection and dosing determination. Weekly assessments completed by subjects will help determine response, tolerability, and necessity for dose adjustment or medication change.

Other:
• Enhanced Fear Avoidance Rehabilitation
The EFAR treatment utilizes physical therapy, pain education, and motivational messaging to improve pain, function, and depression outcomes. Subjects will engage in gradual exposure to exercises and activities they are apprehensive about, such as standing to wash dishes.

Locations

Country	Name	City	State
United States	BWH Pain Management Center	Chestnut Hill	Massachusetts
United States	UPMC Pain Medicine At Centre Commons	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (5)

Lead Sponsor	Collaborator
Ajay Wasan, MD, Msc	Brigham and Women's Hospital, Mayo Clinic, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Physical Function at 4 months using PROMIS	The PROMIS Short Form v2.0 - Physical Function 6b questionnaire will assess self-reported capability with 6 qualitatively scaled questions ranked on a 5-point scale, from "without any difficulty" to "unable to do" or "not at all" to "cannot do." The minimum raw summed score is 6 and the maximum score is 30. Lower t-scores suggest better outcomes.	Baseline vs. 4 months
Primary	Change from Baseline Pain Intensity at 4 months using PROMIS	The PROMIS Numeric Rating Scale v1.0 - Pain Intensity 1a questionnaire will assess how much a person hurts with a question ranked on a 11-point scale, from "0 = no pain" to "10 = worst imaginable pain." The minimum raw summed score is 0 and the maximum score is 10. Lower raw response scores suggest lower pain intensity and better outcomes.	Baseline vs. 4 months
Primary	Change from Baseline Depression at 4 months using PROMIS	The PROMIS Short Form v1.0 - Depression 4a will assess self-reported negative mood and views of self with 4 questions ranked on a 5-point scale, from "never" to "always". The minimum raw summed score is 4 and the maximum score is 20. Lower t-scores suggest better outcomes. Outcomes will be measured and compared between the 3 treatment groups.	Baseline vs. 4 months
Secondary	Change from Baseline Pain Interference at 4 months using PROMIS	The PROMIS Short Form v1.1 - Pain Interference 4a will assess self-reported consequences of pain with 4 questions ranked on a 5-point scale, from "not at all" to "very much". The minimum raw summed score is 4 and the maximum score is 20. Lower t-scores suggest better outcomes. Outcomes will be measured and compared between the 3 treatment groups.	Baseline vs. 4 months
Secondary	Change from Baseline Anxiety at 4 months using PROMIS	The PROMIS Short Form v1.0 - Anxiety 4a will assess self-reported fear, anxious misery, hyperarousal, and somatic symptoms with 4 questions ranked on a 5-point scale, from "never" to "always". The minimum raw summed score is 4 and the maximum score is 20. Lower t-scores suggest better outcomes. Outcomes will be measured and compared between the 3 treatment groups.	Baseline vs. 4 months
Secondary	Change from Baseline Sleep at 4 months using PROMIS	The PROMIS Short Form v1.0 - Sleep Disturbance 6a self-reported perceptions of sleep quality and sleep depth with 6 questions ranked on a 5-point scale. The minimum raw summed score is 6 and the maximum score is 30. Lower t-scores suggest better outcomes. Outcomes will be measured and compared between the 3 treatment groups.	Baseline vs. 4 months
Secondary	Change from Baseline Opioid Cravings at 4 months using the Craving Index	The Craving Index questionnaire will assess opioid cravings with 4 questions ranked on a 0-10 scale, from "0 = not at all" to the "10 = strong as possible." Lower scores suggest lower craving.	Baseline vs. 4 months
Secondary	Change from Baseline Subject's Perception of Change from Treatment at 4 months using Patient Global Impression of Change (PGIC)	The subject's impression of the impact of the treatment on their pain and function will be measured with a 7-item scale (1 = very much worse, 2 = much worse, 3 = minimally worse, 4 = no change, 5 = minimally improved, 6 = much improved, 7 = very much improved).	Baseline vs. 4 months
Secondary	Change from Baseline Opioid Misuse at 4 months using Current Opioid Misuse Measure	The Current Opioid Misuse Measure (COMM) questionnaire will assess recent feelings and behaviors with 17 questions ranked on a 5-point scale, from "never" to "very often". The minimum raw summed score is 0 and the maximum score is 68. Lower scores suggest little to no opioid misuse.	Baseline vs. 4 months