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临床试验/NCT03353272
NCT03353272已完成不适用

The Influence of a Cognitive Behavioral Approach on Changing Patient Expectations in Shoulder Pain

Duke University2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2018年9月18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
55
试验地点
2
主要终点
Pursuance of Surgical Intervention

研究概览

简要总结

Background: Despite similar treatment outcomes for surgery or conservative care, the number of surgeries for the care of rotator cuff (RTC) related shoulder pain has increased. With the increase in surgery, there is an increased risk of harms, increased costs, and high re-tear rates. Patient expectations are beliefs or attitudes that include pre-treatment thoughts and beliefs regarding the need for specific treatment methods and the timing and intensity of these methods. Brief interventions designed to alter and enhance treatment expectations for conservative care and have been shown to improve patient expectations, but to date, no studies have explored whether such interventions can influence patient decisions to pursue surgical care. The investigators propose a comprehensive intervention that involves Patient Engagement Education, and Restructuring of Cognitions (PEERC) that is designed to change expectations, will reduce the likelihood that patients will choose to have shoulder surgery and improve functional outcomes. The cognitive behavioral therapy (CBT) approaches that form the core of our PEERC protocol are patient-centered and are designed to empower the patient in their own recovery process.

Purpose/Aims: To examine the effect of the PEERC protocol on the decision to have surgery (primary), and improve global well-being, pain catastrophizing, pain, functional outcomes, and follow up expectations (secondary).

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, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 to 70
  • A rotator cuff related shoulder pain diagnosis
  • A mobile or land-line telephone
  • Ability to read and write English for completion of the self-report forms.

排除标准

  • The investigators will exclude patients who have received or are scheduled for a surgical intervention for their shoulder condition
  • Demonstrate any evidence of cervicogenic pain and/or radiculopathy from cervical origin
  • Who demonstrate symptoms consistent with thoracic outlet syndrome
  • The investigators will also exclude individuals who are undergoing treatment for a serious psychological disorder (e.g., severe depression, psychosis).

结局指标

主要结局

Pursuance of Surgical Intervention

时间窗: 6 Months

The subject will be questioned if, after physical therapy, he or she will pursue surgery to address continued shoulder pain.

次要结局

  • Change in Pain(Baseline, 6 weeks, Discharge (estimated 3 months))
  • Change in GRoC - Global rate of change(6 weeks, Discharge (estimated 3 months))
  • Change in SPADI - Shoulder Pain and Disability Index(Baseline, 6 weeks, Discharge (estimated 3 months))
  • Change in MODEMS(Baseline, 3 weeks, 6 weeks, Discharge (estimated 3 months))
  • OSPRO 10 - Optimal Screening for Prediction of Referral and Outcome(Baseline)
  • Overall Satisfaction with Care(6 months)
  • SANE - Single Assessment Numeric Evaluation(6 months)
  • Change in TEGNER(Baseline, Discharge (estimated 3 months))
  • Pain Catastrophizing Scale(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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