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

Primary Purpose

Chronic Low Back Pain, Negative Affectivity

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Antidepressant

Enhanced Fear Avoidance Rehabilitation

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

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Arm Label

Antidepressant (AD)

Enhanced Fear Avoidance Rehabilitation (EFAR)

Antidepressant (AD) + Enhanced Fear Avoidance Rehabilitation (EFAR)

AD -> EFAR

EFAR -> AD

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

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.

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.

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.

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.

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).

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.

Full Information

NCT ID

NCT04747314

First Posted

January 6, 2021

Last Updated

April 20, 2023

Sponsor

Ajay Wasan, MD, Msc

Collaborators

National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Brigham and Women's Hospital, Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT04747314

Brief Title

Treating Negative Affect in Low Back Pain Patients

Acronym

TNA-LBP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 31, 2021 (Actual)

Primary Completion Date

December 31, 2025 (Anticipated)

Study Completion Date

April 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Ajay Wasan, MD, Msc

Collaborators

National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Brigham and Women's Hospital, Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Low Back Pain, Negative Affectivity

Keywords

chronic pain, low back pain, fibromyalgia, mood, affect, depression, anxiety, opioid use

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Sequential Assignment

Masking

Care ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Antidepressant (AD)

Arm Type

Experimental

Arm Description

Arm Title

Enhanced Fear Avoidance Rehabilitation (EFAR)

Arm Type

Experimental

Arm Description

Arm Title

Antidepressant (AD) + Enhanced Fear Avoidance Rehabilitation (EFAR)

Arm Type

Experimental

Arm Description

Arm Title

AD -> EFAR

Arm Type

Experimental

Arm Description

Arm Title

EFAR -> AD

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Antidepressant

Other Intervention Name(s)

AD: aripiprazole, bupropion, duloxetine, escitalopram, mirtazapine, sertraline, venlafaxine

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Enhanced Fear Avoidance Rehabilitation

Other Intervention Name(s)

EFAR

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change from Baseline Physical Function at 4 months using PROMIS

Description

Time Frame

Baseline vs. 4 months

Title

Change from Baseline Pain Intensity at 4 months using PROMIS

Description

Time Frame

Baseline vs. 4 months

Title

Change from Baseline Depression at 4 months using PROMIS

Description

Time Frame

Baseline vs. 4 months

Secondary Outcome Measure Information:

Title

Change from Baseline Pain Interference at 4 months using PROMIS

Description

Time Frame

Baseline vs. 4 months

Title

Change from Baseline Anxiety at 4 months using PROMIS

Description

Time Frame

Baseline vs. 4 months

Title

Change from Baseline Sleep at 4 months using PROMIS

Description

Time Frame

Baseline vs. 4 months

Title

Change from Baseline Opioid Cravings at 4 months using the Craving Index

Description

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.

Time Frame

Baseline vs. 4 months

Title

Change from Baseline Subject's Perception of Change from Treatment at 4 months using Patient Global Impression of Change (PGIC)

Description

Time Frame

Baseline vs. 4 months

Title

Change from Baseline Opioid Misuse at 4 months using Current Opioid Misuse Measure

Description

Time Frame

Baseline vs. 4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bhagyasri Jain Dharmaraj, BPharm

Phone

(412)-665-2904

bhd20@pitt.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ajay Wasan, MD, MSc

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

BWH Pain Management Center

City

Chestnut Hill

State/Province

Massachusetts

ZIP/Postal Code

02467

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marise Cornelius

Phone

617-732-9463

mcornelius@bwh.harvard.edu

First Name & Middle Initial & Last Name & Degree

Robert Edwards, PhD

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anita Stoltenberg

Phone

507-422-0582

stoltenberg.anita@mayo.edu

First Name & Middle Initial & Last Name & Degree

Michael Hooten, M.D.

Facility Name

UPMC Pain Medicine At Centre Commons

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15206

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bhagyasri Dharmaraj

Phone

412-665-2904

bhd20@pitt.edu

First Name & Middle Initial & Last Name & Degree

Caitlin E Mickles

Phone

(412)-665-2903

cem218@pitt.edu

First Name & Middle Initial & Last Name & Degree

Ajay Wasan, MD, MSc

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Treating Negative Affect in Low Back Pain Patients

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