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Physical Therapy + Antidepressant for Chronic Lower Back Pain with Depression (TNA-LBP Trial)
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.
TNA-LBP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTNA-LBP Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2015 Phase 2 & 3 trial • 150 Patients • NCT00767624TNA-LBP Trial Design
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- My lower back pain ranges from mild to severe without major nerve damage.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.My average pain score is above 3, and my main pain area is my lower back.I cannot walk by myself.My cognitive function is above the minimum required level.I haven't started new pain or psychiatric treatments in the last 2 weeks.My lower back pain ranges from mild to severe without major nerve damage.You need to score higher than 3 on a test that measures how well you can think and remember things.My average pain score is above 3, and my main pain area is my lower back.I have been experiencing pain for more than 6 months.I am between 18 and 75 years old.I have sought medical help for my low back pain.I have been experiencing pain for more than 6 months.I agree not to increase my opioid medication during the study.My main pain is in my lower back, and it's more than a 3 out of 10.I plan to start or increase pain treatments during the study.My lower back pain ranges from mild to severe without major nerve damage.My average pain score is above 3, and my main pain area is my lower back.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.You need to have a high level of negative feelings at the first study visit, which means scoring at least 5 on a questionnaire called the PHQ-4. Scores above this level are strongly linked to having a diagnosis of major depression or generalized anxiety disorder.You do not currently have thoughts of harming yourself or a history of serious mental health conditions like mania or psychosis.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.I've had a lumbar spine X-ray to check for serious issues.I have been experiencing pain for more than 6 months.I am between 18 and 75 years old.My lower back pain ranges from mild to severe without major nerve damage.I agree not to increase my opioid medication during the study.I have been experiencing pain for more than 6 months.If you take opioids, you haven't had a problem with drugs in the past year. However, using tobacco, medical marijuana, or some prescription opioids might be okay.
- Group 1: AD -> EFAR
- Group 2: Antidepressant (AD) + Enhanced Fear Avoidance Rehabilitation (EFAR)
- Group 3: EFAR -> AD
- Group 4: Antidepressant (AD)
- Group 5: Enhanced Fear Avoidance Rehabilitation (EFAR)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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