Chronic Low Back PainPhase 2TNA-LBPNCT04747314
Treating Negative Affect in Low Back Pain Patients
A Phase 2 study testing Antidepressant and Enhanced Fear Avoidance Rehabilitation in people with Chronic Low Back Pain and Negative Affectivity, run by Ajay Wasan, MD, Msc at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Low Back Pain, Negative Affectivity
- What is being tested?
- Antidepressant and Enhanced Fear Avoidance Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 3 sitesUnited States
- Study dates
- 31 Mar 2021to 20 Dec 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 13Show fewer
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
BWH Pain Management Center
Chestnut Hill, Massachusetts, 02467
UPMC Pain Medicine At Centre Commons
Pittsburgh, Pennsylvania, 15206
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Proof of Concept Study to Treat Negative Affect in Chronic Low Back Pain
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.
Read the detailed description
Approximately 20 million Americans are affected by chronic low back pain and negative affective states such as depression and anxiety. These negative states have all been associated with higher pain intensity, lower pain tolerance, greater use of pain medication, poor pain treatment responses, and higher levels of psychiatric comorbidity among low back pain patients. To improve these outcomes for those who suffer from low back pain, it is important to implement multiple methods with a focus in treating negative affect for pain management rather than using opioids alone.
Antidepressant (AD) and fear avoidance-based physical therapy (EFAR) have individually shown to be promising methods for pain management. In this study, AD, EFAR, and the combination therapy of the two treatments will be explored and implemented to investigate their effectiveness in improving pain, function, depression, and anxiety. The key innovation is testing a new and effective multimodal treatment that can help manage pain, as well as address negative affect.
- Conditions
- Chronic Low Back Pain, Negative Affectivity
- Being tested
- Antidepressant, Enhanced Fear Avoidance Rehabilitation
- Keywords
- chronic pain, low back pain, fibromyalgia, mood, affect, depression, anxiety, opioid use
- Medical subject headings
- Chronic Pain, Low Back Pain, Fibromyalgia, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntidepressantDrug
Also called AD: aripiprazole, bupropion, duloxetine, escitalopram, mirtazapine, sertraline, venlafaxine
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.
Enhanced Fear Avoidance RehabilitationOther
Also called EFAR
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.
| Study group | Role | What they receive |
|---|---|---|
| Antidepressant (AD) | Experimental | 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. Receives: Drug: Antidepressant |
| Enhanced Fear Avoidance Rehabilitation (EFAR) | Experimental | 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. Receives: Other: Enhanced Fear Avoidance Rehabilitation |
| Antidepressant (AD) + Enhanced Fear Avoidance Rehabilitation (EFAR) | Experimental | 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. Receives: Drug: Antidepressant; Other: Enhanced Fear Avoidance Rehabilitation |
| AD -> EFAR | Experimental | 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. Receives: Drug: Antidepressant; Other: Enhanced Fear Avoidance Rehabilitation |
| EFAR -> AD | Experimental | 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. Receives: Drug: Antidepressant; Other: Enhanced Fear Avoidance Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
"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).
Measured: Baseline vs. 4th month of study
Secondary outcomes (9)
Change From Baseline Pain Interference at 4 Months Using PROMIS
The PROMIS Short Form v1.1 - Pain Interference 4a will assess self-reported consequences of pain with 4 questions ranked on a 5-point scale, from "not at all" to "very much". The minimum raw summed score is 4 and the maximum score is 20. This is converted to a T score. A lower T-scores suggest better outcomes. The population mean is 50 and 10 points is +/- 1 standard deviation. A T score >60 suggests moderately elevated levels of the measure. Outcomes will be measured and compared between the 3 treatment groups.
Measured: Baseline vs. 4 months
Change From Baseline Anxiety at 4 Months Using PROMIS
The PROMIS Short Form v1.0 - Anxiety 4a will assess self-reported symptoms with 4 questions ranked on a 5-point scale, from "never" to "always". The minimum raw score is a 4 and the maximum is 20.. These are converted to a T score. The population mean is 50 and 10 points is +/- 1 standard deviation. A T score >60 suggests moderately elevated levels of the measure. Lower T-scores suggest better outcomes. Outcomes will be measured and compared between the 3 treatment groups.
Measured: Baseline vs. 4 months
Change From Baseline Sleep Disturbance at 4 Months Using PROMIS
The PROMIS Short Form v1.0 - Sleep Disturbance 6a self-reported perceptions of sleep quality and sleep depth with 6 questions ranked on a 5-point scale. The minimum raw summed score is 6 and the maximum score is 30. This is converted to a T score. Lower T scores suggest better outcomes. Outcomes will be measured and compared between the 3 treatment groups. The population mean is 50 and 10 points is +/- 1 standard deviation. A T score >60 suggests moderately elevated levels of the measure.
Measured: Baseline vs. 4 months
Change From Baseline Subject's Perception of Change From Treatment at 4 Months Using Patient Global Impression of Change (PGIC)
The subject's impression of the impact of the treatment on their pain and function will be measured with a 7-item scale (1 = very much worse, 2 = much worse, 3 = minimally worse, 4 = no change, 5 = minimally improved, 6 = much improved, 7 = very much improved). This is the percentage reporting "very much improved" or "much improved" at the end of Phase 1. We averaged their PGIC ratings in the 4th month.
Measured: Baseline vs. 4 months
Neuropathic Pain Symptoms Change, Baseline vs. 4 Months
Using PainDetect, we will compare changes in neuropathic pain symptoms from baseline to 4 months. PainDetect is scored from 0-38 and based on ratings to symptom items scored from '0' (never) to '5' (very strongly). Lower scores are better.
Measured: Baseline vs. 4 months
Fear Avoidance Beliefs, Baseline vs. 4 Months
Using the Fear Avoidance Beliefs Questionnaire, Physical Activities Items, subjects rate from '0' (completely disagree) to '6' (completely agree) five physical activities which may make their pain worse. The items are summed to produce the total score. The minimum score is a 0 and the maximum is a 30. Lower scores are better.
Measured: Baseline vs. 4 months
Widespread Pain Index
This measure assesses the degree of widespread pain. 20 body regions are rated by patient as having pain or not. The minumum scores is a 0 and the maximum is a 20. The number of regions is summed to give the total score. Lower scores are better.
Measured: Baseline vs. 4 months
Change in PROMIS Fatigue Score From Baseline vs. 4 Months
The PROMIS short form v. 1.0 for Fatigue consists of 2 items rated from 1-5, from "not at all" to "very much." The minimum raw score is a 2 and the maximum is a 10. The raw score is summed and converted to a T score. Lower T scores are better. The population mean is 50 and 10 points is +/- 1 standard deviation. A T score >60 suggests moderately elevated levels of the measure.
Measured: Baseline vs. 4 months
WPI Symptom Severity Score
Overall symptom severity is rated 0-10. Lower scores are better.
Measured: Baseline to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start31 Mar 2021
- Primary completion4 Nov 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajay Wasan, MD, Msc
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Mayo Clinic, Massachusetts General Hospital
- Responsible party
- Sponsor-investigator, Ajay Wasan, MD, Msc, University of Pittsburgh
- Investigators
- Ajay Wasan, MD, MSc, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747314
- Sponsor's protocol ID
- STUDY21010105
- Other IDs
- UG3AR076568
- Acronym
- TNA-LBP
- Status last verified
- Aug 2026
- First submitted
- 6 Jan 2021
- Last updated
- 28 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36715655
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept Study to Treat Negative Affect in Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT04747314
- Acronym / sponsor ID
- TNA-LBP / STUDY21010105
- Conditions
- Chronic Low Back Pain, Negative Affectivity
- Keywords
- chronic pain, low back pain, fibromyalgia, mood, affect, depression, anxiety, opioid use
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Ajay Wasan, MD, MscUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Mayo Clinic, Massachusetts General Hospital
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 4 Nov 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Posted 25 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Approximately 20 million Americans are affected by chronic low back pain and negative affective states such as depression and anxiety. These negative states have all been associated with higher pain intensity, lower pain tolerance, greater use of pain medication, poor pain treatment responses, and higher levels of psychiatric comorbidity among low back pain patients. To improve these outcomes for those who suffer from low back pain, it is important to implement multiple methods with a focus in treating negative affect for pain management rather than using opioids alone.
Antidepressant (AD) and fear avoidance-based physical therapy (EFAR) have individually shown to be promising methods for pain management. In this study, AD, EFAR, and the combination therapy of the two treatments will be explored and implemented to investigate their effectiveness in improving pain, function, depression, and anxiety. The key innovation is testing a new and effective multimodal treatment that can help manage pain, as well as address negative affect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Antidepressant (AD) | Experimental | Drug: AntidepressantSubjects 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. |
| Enhanced Fear Avoidance Rehabilitation (EFAR) | Experimental | Other: Enhanced Fear Avoidance RehabilitationSubjects 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. |
| Antidepressant (AD) + Enhanced Fear Avoidance Rehabilitation (EFAR) | Experimental | Drug: Antidepressant, Other: Enhanced Fear Avoidance RehabilitationSubjects 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. |
| AD -> EFAR | Experimental | Drug: Antidepressant, Other: Enhanced Fear Avoidance RehabilitationSubjects 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. |
| EFAR -> AD | Experimental | Drug: Antidepressant, Other: Enhanced Fear Avoidance RehabilitationSubjects 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntidepressantAlso: AD: aripiprazole, bupropion, duloxetine, escitalopram, mirtazapine, sertraline, venlafaxineThe 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. | Drug | AD -> EFAR, Antidepressant (AD), Antidepressant (AD) + Enhanced Fear Avoidance Rehabilitation (EFAR), EFAR -> AD |
| Enhanced Fear Avoidance RehabilitationAlso: EFARThe 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. | Other | AD -> EFAR, Antidepressant (AD) + Enhanced Fear Avoidance Rehabilitation (EFAR), EFAR -> AD, Enhanced Fear Avoidance Rehabilitation (EFAR) |
Primary outcome
"Composite Responder", Involving the Domains of Pain, Function, and Depression. See "Other Pre-Specified Outcomes" for Description of These Sub-components.
Time frame: Baseline vs. 4th month of study
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).
9 secondary outcomes
Change From Baseline Pain Interference at 4 Months Using PROMIS
Time frame: Baseline vs. 4 months
Change From Baseline Anxiety at 4 Months Using PROMIS
Time frame: Baseline vs. 4 months
Change From Baseline Sleep Disturbance at 4 Months Using PROMIS
Time frame: Baseline vs. 4 months
Change From Baseline Subject's Perception of Change From Treatment at 4 Months Using Patient Global Impression of Change (PGIC)
Time frame: Baseline vs. 4 months
Neuropathic Pain Symptoms Change, Baseline vs. 4 Months
Time frame: Baseline vs. 4 months
Fear Avoidance Beliefs, Baseline vs. 4 Months
Time frame: Baseline vs. 4 months
Widespread Pain Index
Time frame: Baseline vs. 4 months
Change in PROMIS Fatigue Score From Baseline vs. 4 Months
Time frame: Baseline vs. 4 months
WPI Symptom Severity Score
Time frame: Baseline to 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36715655Wasan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ajay Wasan, MD, MSc principal investigator
University of Pittsburgh
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Antidepressant and Enhanced Fear Avoidance Rehabilitation in people with Chronic Low Back Pain and Negative Affectivity, run by Ajay Wasan, MD, Msc at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Composite Responder", Involving the Domains of Pain, Function, and Depression. See "Other Pre-Specified Outcomes" for Description of These Sub-components. (time frame: Baseline vs. 4th month of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04747314, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.