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临床试验/NCT02133976
NCT02133976已完成不适用

Comparative Mechanisms (Mediators, Moderators) of Psychosocial Chronic Pain Treatments

Rush University Medical Center2 个研究点 分布在 1 个国家目标入组 521 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
521
试验地点
2
主要终点
Pain interference

研究概览

简要总结

Psychosocial interventions are attractive options for treating chronic low back pain, and many approaches now have strong support for efficacy. However, few empirical data address whether psychosocial pain treatments work because of mechanisms specified by theory, and thus investigators know very little about HOW our treatments work. It may be that different treatments work via distinct pathways that are specific to a given treatment (single effect model), or it may be that different treatments work to the extent they all operate via key mechanisms that they share (additive effects model). Examination of specific and/or shared effects on outcomes of mechanisms will provide theoretical and empirical rationale for enhancing procedures and techniques most closely linked to strong outcomes and incorporating them into future interventions, while limiting the use of others that may be revealed as inert.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • significant daily chronic pain intensity (at least 4 on a 10-point scale; see below) and interference in performing daily activities due to pain (at least 3 on a 6-point scale; see below) for at least 6 months
  • musculoskeletal pain of the low back and/or leg pain that may be related to history of degenerative disk disease, spinal stenosis, or disk herniation (radiculopathy subcategory), or muscular or ligamentous strain (chronic myofascial pain subcategory)
  • age between 18 and 75 years.

排除标准

  • meet criteria for alcohol or substance abuse problems
  • meet criteria for past or present psychotic or bipolar disorders
  • inability to understand English well enough to complete questionnaires or to participate in therapy
  • active suicidal ideation with intent
  • pain is due to malignant conditions (eg, cancer, rheumatoid arthritis), migraine or tension headache, fibromyalgia or complex regional pain syndrome.

结局指标

主要结局

Pain interference

时间窗: 12 months

Pain interference will be assessed with Pain Interference Subscale items of the Multidimensional Pain Inventory

次要结局

  • Activity level(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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