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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline vs. 4 months
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline vs. 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline vs. 4 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreSide effects data
From 2015 Phase 2 & 3 trial • 150 Patients • NCT007676241%
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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?
Mayo ClinicOTHER
3,343 Previous Clinical Trials
3,062,019 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,817 Previous Clinical Trials
8,161,429 Total Patients Enrolled
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
496 Previous Clinical Trials
1,089,182 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had back surgery in the last 6 months.I plan to start new psychiatric treatments within the first 4 months of the study.My main pain is in my lower back, and it's more than a 3 out of 10.I am between 18 and 75 years old.I have been on opioids, like oxycodone or tramadol, for pain for at least 3 months.I cannot walk by myself.I haven't started new pain or psychiatric treatments in the last 2 weeks.I have sought medical help for my low back pain.I agree not to increase my opioid medication during the study.I plan to start or increase pain treatments during the study.My lower back pain ranges from mild to severe without major nerve damage.You need to have had a previous X-ray of your lower back to make sure there are no serious issues like infection, tumor, or fracture.I have been on opioids, like oxycodone or tramadol, for pain for at least 3 months.I have been experiencing pain for more than 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: AD -> EFAR
- Group 2: EFAR -> AD
- Group 3: Antidepressant (AD)
- Group 4: Antidepressant (AD) + Enhanced Fear Avoidance Rehabilitation (EFAR)
- Group 5: Enhanced Fear Avoidance Rehabilitation (EFAR)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Chronic Lower Back Pain Patient Testimony for trial: Trial Name: NCT04747314 — Phase 2 & 3
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