Name: Proof of Concept Study to Treat Negative Affect in Chronic Low Back Pain
Creator: Trial Radar
Published: 2025-03-13
License: https://www.clinicaltrials.gov/about-site/terms-conditions#availability

卡片视图

Treating Negative Affect in Low Back Pain Patients (TNA-LBP)

进行中但不再招募

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临床试验NCT04747314 (TNA-LBP)旨在研究治疗，主要针对慢性下背痛，Negative Affectivity。这是一项II期 (第二期) III期 (第三期) 干预性研究试验，目前试验状态为进行中但不再招募。试验始于2021年3月31日，计划招募330名患者。该研究由Ajay Wasan, MD, Msc主导，预计于2026年4月30日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年3月13日。

简要概括

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.

详细描述

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.

官方标题

Proof of Concept Study to Treat Negative Affect in Chronic Low Back Pain

疾病

慢性下背痛Negative Affectivity

出版物

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.

其他研究标识符

NCT编号

NCT04747314

实际开始日期

2021-03-31

最近更新发布

2025-03-13

预计完成日期

2026-04-30

计划入组人数

330

研究类型

干预性研究

试验分期 (阶段)

II期 (第二期)
III期 (第三期)

试验状态

进行中但不再招募

关键词

chronic pain
low back pain
fibromyalgia
mood
affect
depression
anxiety
opioid use

主要目的

治疗方法

分配方式

随机

干预模型

序贯设计

盲法

双盲

试验组/干预措施

参与者组/试验组	干预措施/治疗方法
实验性Antidepressant (AD) 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.	Antidepressant 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.
实验性Enhanced Fear Avoidance Rehabilitation (EFAR) 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.	Enhanced Fear Avoidance Rehabilitation The EFAR treatment utilizes physical therapy, 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.
实验性Antidepressant (AD) + Enhanced Fear Avoidance Rehabilitation (EFAR) 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.	Antidepressant 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 Rehabilitation The EFAR treatment utilizes physical therapy, 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.
实验性AD -> EFAR 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.	Antidepressant 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 Rehabilitation The EFAR treatment utilizes physical therapy, 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.
实验性EFAR -> AD 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.	Antidepressant 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 Rehabilitation The EFAR treatment utilizes physical therapy, 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.

研究衡量的是什么？

主要终点

结果指标	度量标准描述	时间框架
Change from Baseline Physical Function at 4 months using PROMIS (combined with pain intensity to form a combined measure)	The PROMIS Short Form v2.0 - Physical Function 6b questionnaire will assess self-reported capability with 6 qualitatively scaled questions ranked on a 5-point scale, from "without any difficulty" to "unable to do" or "not at all" to "cannot do." The minimum raw summed score is 6 and the maximum score is 30. Lower t-scores suggest better outcomes.	Baseline vs. 4 months
Change from Baseline Pain Intensity at 4 months using PROMIS (combined with function to form a combined measure).	The PROMIS Numeric Rating Scale v1.0 - Pain Intensity 1a questionnaire will assess how much a person hurts with a question ranked on a 11-point scale, from "0 = no pain" to "10 = worst imaginable pain." The minimum raw summed score is 0 and the maximum score is 10. Lower raw response scores suggest lower pain intensity and better outcomes.	Baseline vs. 4 months
Change from Baseline Depression at 4 months using PROMIS	The PROMIS Short Form v1.0 - Depression 4a will assess self-reported negative mood and views of self with 4 questions ranked on a 5-point scale, from "never" to "always". The minimum raw summed score is 4 and the maximum score is 20. Lower t-scores suggest better outcomes. Outcomes will be measured and compared between the 3 treatment groups.	Baseline vs. 4 months

次要终点

结果指标	度量标准描述	时间框架
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. Lower t-scores suggest better outcomes. Outcomes will be measured and compared between the 3 treatment groups.	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 fear, anxious misery, hyperarousal, and somatic symptoms with 4 questions ranked on a 5-point scale, from "never" to "always". The minimum raw summed score is 4 and the maximum score is 20. Lower t-scores suggest better outcomes. Outcomes will be measured and compared between the 3 treatment groups.	Baseline vs. 4 months
Change from Baseline Sleep 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. Lower t-scores suggest better outcomes. Outcomes will be measured and compared between the 3 treatment groups.	Baseline vs. 4 months
Change from Baseline Opioid Cravings at 4 months using the Craving Index	The Craving Index questionnaire will assess opioid cravings with 4 questions ranked on a 0-10 scale, from "0 = not at all" to the "10 = strong as possible." Lower scores suggest lower craving.	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).	Baseline vs. 4 months
Change from Baseline Opioid Misuse at 4 months using Current Opioid Misuse Measure	The Current Opioid Misuse Measure (COMM) questionnaire will assess recent feelings and behaviors with 17 questions ranked on a 5-point scale, from "never" to "very often". The minimum raw summed score is 0 and the maximum score is 68. Lower scores suggest little to no opioid misuse.	Baseline vs. 4 months

资格标准

适龄参与研究

成人, 老年人

最低年龄要求

18 Years

适龄性别

全部

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
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

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

Ajay Wasan, MD, Msc

⚕️National Institutes of Health (NIH)
🏛️National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
妙佑医疗国际868 个活跃的临床试验可供探索
🏥Massachusetts General Hospital

研究责任方

Ajay Wasan, MD, Msc, 申办者-研究者, Professor, University of Pittsburgh

没有联系数据。

3 位于 1 个国家/地区的研究中心

美国

Massachusetts

BWH Pain Management Center, Chestnut Hill, Massachusetts, 02467, United States

Minnesota

Mayo Clinic, Rochester, Minnesota, 55905, United States

Pennsylvania

UPMC Pain Medicine At Centre Commons, Pittsburgh, Pennsylvania, 15206, United States

临床试验雷达

试验分期 (阶段)

类型

试验类型

年龄组

生物性别

Treating Negative Affect in Low Back Pain Patients (TNA-LBP)

安慰剂

试验分期 (阶段)

类型

试验类型

年龄组

生物性别

Treating Negative Affect in Low Back Pain Patients (TNA-LBP)

入选标准

排除标准