NCT04747314|CompletedPhase 2ResultsDMCFDA Drug
Treating Negative Affect in Low Back Pain Patients
TNA-LBP
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TNA-LBP
Proof of Concept Study to Treat Negative Affect in Chronic Low Back Pain
Sponsor study identifier
Secondary identifiers
NIH
interventional
308
1 country
3
Study Start
March 31, 2021
Actual (reported)Primary Completion
November 4, 2024
Actual (reported)Study Completion
December 20, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 20, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 6, 2021
Actual (reported)February 10, 2021
Actual (reported)March 31, 2021
Actual (reported)November 4, 2024
Actual (reported)December 20, 2024
Actual (reported)August 25, 2026
Actual (reported)"Composite Responder", Involving the Domains of Pain, Function, and Depression. See "Other Pre-Specified Outcomes" for Description of These Sub-components.
To create the "composite responder" measure, Pain+ function changes will be 1 meaure, and the response rate to depression will be the 2nd component, which simplifies the assessment of multi-domain responses. We will determine the "composite responder" rate of multimodal vs. single-modal treatment primarily, and then between each arm secondarily, along with the subcomponents. The "composite responder" measure will be the number and percentage of participants meeting the measure in each arm in Phase 1. A participant could be a pain+function responder, a depression responder, both, or neither. We use standard benchmarks for determining responses in each domain. The primary outcome is the rate of response vs. non-response on the "Composite Responder" measure. It will be expressed as percentiles in each category. We will also report the rate of pain+function responders and the rate of depression responders (other pre-specified outcomes).
Baseline vs. 4th month of study
Change From Baseline Pain Interference at 4 Months Using PROMIS
Subjects will be randomly assigned to receive the antidepressant medication for 4 months prescribed by a psychiatrist or an advanced practice provider supervised by a psychiatrist. During Phase 1 phone calls every 2 weeks or in person visits will be used to evaluate the treatment and adjust the medication. If the patient was prescribed opioids prior to study entry, they will meet separately with a study physician to discuss possible weaning during the first 4 months (Phase 1) Non-responders determined at the end of 4 months will be re-randomized to continue receiving AD or EFAR for another 4 months.
Subjects will be randomly assigned to receive 8, 1-hour fear avoidance rehabilitation sessions conducted by a physical or occupational therapist, consisting of therapy sessions, pain education, and motivational messaging via a pain education self-help app for 4 months. Trained physical/occupational therapists will determine the activities as part of the treatment. If the patient was prescribed opioids prior to study entry, they will meet separately with a study physician to discuss possible weaning during the first 4 months (Phase 1). Non-responders determined at the end of 4 months will be re-randomized to continue receiving EFAR or AD for another 4 months.
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.
BWH Pain Management Center
Chestnut Hill, Massachusetts, 02467, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
UPMC Pain Medicine At Centre Commons
Pittsburgh, Pennsylvania, 15206, United States
Wasan AD, Edwards RR, Kraemer KL, Jeong J, Kenney M, Luong K, Cornelius MC, Mickles C, Dharmaraj B, Sharif E, Stoltenberg A, Emerick T, Karp JF, Bair MJ, George SZ, Hooten WM. Back Pain Consortium (BACPAC): Protocol and Pilot Study Results for a Randomized Comparative-Effectiveness Trial of Antidepressants, Fear Avoidance Rehabilitation, or the Combination for Chronic Low Back Pain and Comorbid High Negative Affect. Pain Med. 2023 Aug 4;24(Suppl 1):S105-S114. doi: 10.1093/pm/pnad006.
Ajay Wasan, MD, MSc
University of Pittsburgh
308 participants (actual enrollment reported by the registry).
First Submitted
January 6, 2021
First Posted
February 10, 2021
Study Start
March 31, 2021
Actual (reported)A Study Comparing The Efficacy And Safety Of Lidocaine 5% Patch With Placebo In Patients With Chronic Axial Low Back Pain
A Study of a Topical Patch (AB001) in Patients With Chronic Low Back Pain
Baseline vs. 4 months
Change From Baseline Anxiety at 4 Months Using PROMIS
Baseline vs. 4 months
Change From Baseline Sleep Disturbance at 4 Months Using PROMIS
Baseline vs. 4 months
Change From Baseline Subject's Perception of Change From Treatment at 4 Months Using Patient Global Impression of Change (PGIC)
Baseline vs. 4 months
Neuropathic Pain Symptoms Change, Baseline vs. 4 Months
Baseline vs. 4 months
Change in Physical Function Using PROMIS Short Form 2.0. Function is Part of the Composite Responder Measure, and a Pain+Function Metric More Specifically. A Subject Could be a Pain+Function Responder, a Depression Responder, Both, or Neither.
Baseline vs. 4 months
Change in Pain Intensity Using PROMIS. Pain is Part of the Composite Responder Measure, and a Pain+Function Metric More Specifically. A Subject Could be a Pain+Function Responder, a Depression Responder, Both, or Neither.
Baseline vs. 4 months
Change in Depression Using PROMIS. Depression is Part of the "Composite Responder" Measure. A Subject Could be a Pain+Function Responder, a Depression Responder, Both, or Neither.
Baseline vs. 4 months
Subjects will receive a combination of antidepressant medication and EFAR for the first 4 months (Phase 1). In the 2nd 4 months (Phase 2) the AD treatment will be continued at the same dose(s) and they will be asked to maintain a home exercise program. If the patient was prescribed opioids prior to study entry, they will meet separately with a study physician to discuss possible weaning during the first 4 months (Phase 1). No re-randomization will be done in this treatment group.
Subjects will be randomly assigned to receive the antidepressant medication for 4 months prescribed by a psychiatrist or an advanced practice provider supervised by a psychiatrist. During Phase 1 phone calls every 2 weeks or in person visits will be used to evaluate the treatment and adjust the medication. If the patient was prescribed opioids prior to study entry, they will meet separately with a study physician to discuss possible weaning during the first 4 months (Phase 1) 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 EFAR for 4 months will receive 8 treatment visits. The same opioid weaning process will be followed as in Phase 1.
Subjects will be randomly assigned to receive 8, 1-hour fear avoidance rehabilitation sessions conducted by a physical or occupational therapist, consisting of therapy sessions, pain education, and motivational messaging via a pain education self-help app for 4 months. Therapists will determine the activities as part of the treatment. If the patient was prescribed opioids prior to study entry, they will meet separately with a study physician to discuss possible weaning during the first 4 months (Phase 1). Non-responders at the end of 4 months will be re-randomized to continue receiving EFAR or AD for another 4 months (Phase 2). Those re-randomized to receive AD will be prescribed medications by a psychiatrist or an advanced practice provider supervised by a psychiatrist. Phone calls every 2 weeks or in person visits will be used to evaluate the treatment and adjust the medication. The same opioid weaning process will be followed as in Phase 1.
The EFAR treatment utilizes standardized physical and/or occupational therapy fear avoidance approaches, including 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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
November 4, 2024
Actual (reported)Study Completion
December 20, 2024
Actual (reported)Last Updated
August 28, 2026
Results First Posted
August 25, 2026
Record last verified: 2026-08
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Source: ClinicalTrials.gov.
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