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Antidepressant

Physical Therapy + Antidepressant for Chronic Lower Back Pain with Depression (TNA-LBP Trial)

Phase 2 & 3
Recruiting
Led By Ajay Wasan, MD, MSc
Research Sponsored by Ajay Wasan, MD, Msc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 18-75
Average pain score of > 3/10, with low back pain being the primary pain site
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline vs. 4 months
Awards & highlights

TNA-LBP Trial Summary

This trial will look at how different treatments - antidepressants, physical therapy, or a combination of both - affect pain, ability to function, and depression symptoms in people with chronic low back pain.

Who is the study for?
This trial is for adults aged 18-75 with chronic lower back pain lasting over 6 months, scoring above a 3/10 on the pain scale. Participants must be able to use mobile devices and have no major thought disorders or recent substance abuse (except certain cases). They should not be pregnant, involved in litigation claims, planning new psychiatric treatments, or have had recent back surgery.Check my eligibility
What is being tested?
The study tests how an antidepressant alone, physical therapy alone, or their combination can help manage pain and improve function and mood in those with chronic low back pain. It aims to see which method is most effective for patients who also experience negative emotions like depression.See study design
What are the potential side effects?
Potential side effects may include typical reactions to antidepressants such as nausea, dizziness, sleep disturbances or increased anxiety initially. Physical therapy might cause temporary soreness or discomfort.

TNA-LBP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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My average pain score is above 3, and my main pain area is my lower back.
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I have been experiencing pain for more than 6 months.
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I agree not to increase my opioid medication during the study.
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My lower back pain ranges from mild to severe without major nerve damage.

TNA-LBP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline vs. 4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline vs. 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline Depression at 4 months using PROMIS
Change from Baseline Pain Intensity at 4 months using PROMIS
Change from Baseline Physical Function at 4 months using PROMIS
Secondary outcome measures
Change from Baseline Anxiety at 4 months using PROMIS
Change from Baseline Opioid Cravings at 4 months using the Craving Index
Change from Baseline Opioid Misuse at 4 months using Current Opioid Misuse Measure
+3 more

Side effects data

From 2015 Phase 2 & 3 trial • 150 Patients • NCT00767624
1%
Hematoma R side abdomen
1%
Severe vaginal bleeding and pain
1%
Chest pain in a patient with CAD
1%
Asthma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Antidepressant + Desensitization
Antidepressant + Cognitive Behavioral

TNA-LBP Trial Design

5Treatment groups
Experimental Treatment
Group I: Enhanced Fear Avoidance Rehabilitation (EFAR)Experimental Treatment1 Intervention
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.
Group II: EFAR -> ADExperimental Treatment2 Interventions
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.
Group III: Antidepressant (AD) + Enhanced Fear Avoidance Rehabilitation (EFAR)Experimental Treatment2 Interventions
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.
Group IV: Antidepressant (AD)Experimental Treatment1 Intervention
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.
Group V: AD -> EFARExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Antidepressant
2017
Completed Phase 3
~158930

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,682 Previous Clinical Trials
6,930,468 Total Patients Enrolled
Mayo ClinicOTHER
3,190 Previous Clinical Trials
3,758,771 Total Patients Enrolled
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
483 Previous Clinical Trials
1,086,609 Total Patients Enrolled

Media Library

Antidepressant (Antidepressant) Clinical Trial Eligibility Overview. Trial Name: NCT04747314 — Phase 2 & 3
Chronic Lower Back Pain Research Study Groups: AD -> EFAR, Antidepressant (AD) + Enhanced Fear Avoidance Rehabilitation (EFAR), EFAR -> AD, Antidepressant (AD), Enhanced Fear Avoidance Rehabilitation (EFAR)
Chronic Lower Back Pain Clinical Trial 2023: Antidepressant Highlights & Side Effects. Trial Name: NCT04747314 — Phase 2 & 3
Antidepressant (Antidepressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04747314 — Phase 2 & 3
Chronic Lower Back Pain Patient Testimony for trial: Trial Name: NCT04747314 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other scientific studies that have used Antidepressants in their research?

"The antidepressant was first researched at Vanderbilt University Autonomic Dysfunction Center in 1997. So far, 979 completed trials have been conducted. As of now, 114 clinical trials are actively recruiting, a majority of which are based in Chestnut Hill, Massachusetts."

Answered by AI

Will this experiment be inclusive of elderly patients who are seeking treatment?

"The study's eligibility criteria allow for patients who are between 18-75 years old."

Answered by AI

What are the researchers hoping to achieve through this clinical trial?

"The objective of this trial, which will be conducted over a period of 4 months, is to assess the efficacy of the treatment in reducing levels of depression, as measured by the PROMIS scale. Secondary outcomes include changes in the subject's perception of the treatment's impact on their condition, as measured by the Patient Global Impression of Change scale; changes in opioid cravings, as measured by the Craving Index questionnaire; and changes in pain interference, as measured by the PROMIS Short Form v1.1. Outcomes will be compared between the three treatment groups."

Answered by AI

What conditions does Antidepressant commonly help alleviate?

"Antidepressants are often used to help patients suffering from irritability, post-traumatic stress disorder (PTSD), and attention deficit hyperactivity disorder (ADHD)."

Answered by AI

Who is eligible to participate in this research?

"This trial is open to anyone aged 18-75 that suffers from low back pain, with the goal of enrolling around 300 individuals in total."

Answered by AI

Are participants being enrolled in this trial at this time?

"Correct, the information on clinicaltrials.gov does show that this study is still open and looking for volunteers. The trial was first posted on March 31st, 2021 and was last edited on July 13th, 2022. They are hoping to find 300 participants total from 3 different locations."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
Massachusetts
Pennsylvania
How old are they?
18 - 65
65+
What site did they apply to?
BWH Pain Management Center
UPMC Pain Medicine At Centre Commons
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+

What questions have other patients asked about this trial?

I live in Central WI and am not able to drive to your locations. do you have any home studies?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I don't take any Rx for the lower back pain i take two Rx for depression and would like help.
PatientReceived 2+ prior treatments
I've been through therapies, injections, several different pain meds and now all my dr says is there isn't much more she can do. I refuse to let this pain (degenerative arthritis) control me. There has to be something that will work.
PatientReceived no prior treatments
~122 spots leftby Dec 2025