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临床试验/NCT04023435
NCT04023435已完成不适用

Pain Neuroscience Education for Depression

St. Ambrose University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Patient Health Questionnaire - PHQ-9

研究概览

简要总结

This study will look at the effects of Pain Neuroscience Education on a Depression outcome tool in patients with chronic low back pain.

详细描述

Pain and depression have been shown to be interrelated, especially chronic pain: people in chronic pain develop depression and people with depression develop chronic pain. In light of this coexistence it is not surprising that current best-evidence for depression and chronic pain shows significant overlap which includes primarily some type of cognitive intervention, aerobic exercise, and skilled delivery of medication including selective-serotonin-reuptake-inhibitors and/or membrane stabilizers. Current best-evidence regarding musculoskeletal pain provides strong support for Pain Neuroscience Education (PNE) to positively influence pain ratings, dysfunction, and limitations in movement, pain knowledge and healthcare utilization. Additionally, PNE has shown to powerfully influence psychosocial issues that powerfully influence pain and depression: fear-avoidance and pain catastrophization. Evidence is lacking in whether PNE could also influence depression ratings. The purpose of this study is to examine the immediate effect of PNE on pain, function, and depressive symptoms (using the Patient Health Questionnaire - PHQ-9) in patients attending PT for chronic low back pain (LBP).

This will be a pre- and post-intervention convenience sample of consecutive patients with chronic LBP (pain > 6 months) meeting the inclusion criteria, attending outpatient PT. On initial examination, intake data and information will be collected prior to PNE and immediately following PNE.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

No other parties will be masked.

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adults over the age of 18
  • presenting at PT with a primary complaint of LBP
  • LBP being present for 6 months or more
  • fluent in English
  • willing to participate in the study.

排除标准

  • are under age 18 (minor)
  • had undergone lumbar surgery
  • cannot read or understand the English language
  • presents with any cognitive deficits rendering them unsuitable for PNE (i.e., stroke, traumatic brain injury, etc.)
  • decline to participate
  • present with a medical etiology (red flag) associated with their LBP.

结局指标

主要结局

Patient Health Questionnaire - PHQ-9

时间窗: within a single, 90 minute session

The PHQ-9 is the nine item depression scale

Pain Catastrophization Scale

时间窗: within a single, 90 minute session

The PCS is a self-report questionnaire assessing inappropriate coping strategies and catastrophic thinking about pain and injury. on a 13-item, 5-point Likert scale with higher scores indicating elevated levels of catastrophizing.

revised Pain Neurophysiology Questionnaire - rNPQ

时间窗: within a single, 90 minute session

The NPQ measures the neurophysiology knowledge of patients and healthcare personnel. The original NPQ is a 19-item questionnaire requesting 'true'; 'false'; or 'not sure' answers to statements, with higher scores indicating more correct answers.

Low back pain rating

时间窗: within a single, 90 minute session

Numeric Pain Rating Scale for Back Pain (0 = no pain and 10 = worst pain). The minimal detectable change (MDC) for the NPRS for low back pain is reported to be 2.0.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kevin Farrell

Professor and Chair, Orthopaedic Residency Program in Physical Therapy

St. Ambrose University

研究点 (2)

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