Can antidepressants and exercise ease chronic back pain?
NCT ID NCT04747314
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 3 times
Summary
This study looked at whether an antidepressant, physical therapy, or a combination of both can help people with chronic low back pain who also struggle with negative feelings. About 308 adults aged 18-75 with pain lasting over 6 months took part. The goal was to see if these treatments improve pain, daily function, and mood.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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308 people
The number who actually took part.
- Started
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Mar 2021
- Finished
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Dec 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 * In the investigator's judgment, evidence of healthcare seeking for low back pain. * 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 PHQ-4 scores are used as a proxy for high scores on PROMIS depression and anxiety scales * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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BWH Pain Management Center
Chestnut Hill, Massachusetts, 02467, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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UPMC Pain Medicine At Centre Commons
Pittsburgh, Pennsylvania, 15206, United States
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Other studies related to the condition(s) this trial covers.
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