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临床试验/NCT06971809
NCT06971809已完成不适用

Efficacy of a Multi-modal Pain Resilience Approach to Chronic Low Back Pain

Integrative Pain Science Institute1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年5月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Pain intensity

研究概览

简要总结

Chronic pain affects about 20% of adults in the U.S. and can lead to serious personal, social, and economic challenges. It is often treated with medications, including opioids, which carry risks of dependence. While pain education (PE) helps people better understand their pain and may reduce symptoms, it generally has only modest effects when used alone.

The purpose of this study is to explore whether combining pain education with other treatments-such as physical therapy, cognitive behavioral techniques, and healthy lifestyle strategies-in a multi-modal resilience approach can offer greater benefits. The study aims to answer the following question:

Can a combined, whole-person approach improve outcomes in people with chronic pain more effectively than pain education alone?

详细描述

Chronic pain is pain that lasts beyond the typical healing duration, and is typically defined as lasting for at least 3-6 months. Approximately 20% of the adult U.S. population experiences chronic pain. There are a variety of risk factors for developing chronic pain. Female sex, older age, living in poverty, having chronic health conditions or a disability and being a veteran are among the risk factors for chronic pain. Chronic pain impacts quality of life as well as worker productivity. Chronic pain presents an economic burden beyond absenteeism and lost wages and costs the healthcare system upwards of $300 billion for a range of services including medication for pain management, surgeries, and disability compensation. Additionally, opioid prescription for chronic pain is a primary driver of opioid use disorder. Teaching those with chronic pain how to effectively manage their pain can improve quality of life and reduce the risk of developing dependency on opioid medication.

The non-pharmacologic and non-invasive treatment of chronic pain includes physical therapy, cognitive behavioral techniques, and strategies for promoting a healthy lifestyle. Pain education (PE) has been advocated as a methodology to reduce chronic pain. PE teaches that pain is not simply the result of tissue damage. Rather, the foundation of PE is education about the factors that can contribute to pain such as emotions, beliefs, and past experiences.4 However, PE is a singular modality that produces small effects. A multi-modal resilience approach model may produce larger effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults experiencing chronic low back pain of any diagnosis for a duration of at least 6 months.
  • •Ability to read and understand English.
  • •18-85 years of age

排除标准

  • •Experiencing acute pain related to a recent injury or pain lasting less than 6 months.
  • •Inability to read or understand English.
  • •History of metastatic cancer

研究组 & 干预措施

Fear group

Active Comparator

This intervention addresses the negative valence system to decrease fear and threat.

干预措施: Pain education (Behavioral)

Strengths group

Active Comparator

This group addresses the positive valance system for reward learning

干预措施: Pain resilience (Behavioral)

结局指标

主要结局

Pain intensity

时间窗: At baseline (pre-intervention) and at 90-day follow-up.

Pain intensity will be measured by the Defense of Veterans Pain Rating Scale. This is a numerical scale with descriptors 0 = No pain 1. = Hardly noticeable pain 2. = Noticeable pain, but does not interfere with activities 3. = Somewhat distracting pain 4. = Distracting pain, but does not affect normal activities 5. = Pain interrupts some activities 6. = Hard to ignore pain, avoidance of daily activities 7. = Pain is the main focus of attention, prevents daily activities 8. = Awful pain, difficult to do anything 9. = Unbearable pain, cannot do anything 10. = As bad as pain can be, nothing else matters

次要结局

  • Pain Resilience Scale(At baseline (pre-intervention) and at 90-day follow-up.)
  • The Defense and Veterans Pain Rating Scale (DVPRS 2.0)(At baseline (pre-intervention) and at 90-day follow-up.)
  • Patient-Reported Outcomes Measurement Information System (PROMIS®) Pain Interference(At baseline (pre-intervention) and at 90-day follow-up.)
  • Optimal Screening for Prediction of Referral and Outcome-Yellow Flag (OSPRO-YF)(At baseline (pre-intervention) and at 90-day follow-up.)

研究者

发起方
Integrative Pain Science Institute
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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