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临床试验/NCT02498847
NCT02498847已完成1 期

Occupational Therapy-Delivered Cognitive Behavioral Therapy for Symptomatic Knee Osteoarthritis: A Pilot Study

University of Michigan4 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
57
试验地点
4
主要终点
Self-Reported Physical Function-WOMAC

研究概览

简要总结

Knee osteoarthritis (OA) affects 27 million US adults and is a leading cause of pain and disability. Non-pharmacological interventions are recommended but are underutilized. Exercise reduces pain and improves physical function, but benefits tend to wane without a component to facilitate behavior change. Cognitive behavioral therapy (CBT) has long term benefits on pain and physical function in individuals with OA, but is not typically offered in clinical care. CBT could be taught in the context of clinical care by occupational therapists (OT). OTs help people manage chronic conditions by teaching behavioral strategies that promote health and function. The purpose of this study is to test the feasibility and efficacy of an OT-delivered cognitive behavioral therapy program to help people manage their knee OA.

详细描述

Knee OA, in particular, is a major driver of health care costs and is also a leading cause of arthritis-related activity limitations. A common assumption in knee OA treatment is that relief of joint pain will lead to improvements in physical function. However, many factors can influence disability in OA, not only the biomechanical factors which have been the focus of traditional rehabilitation. Although research supports a broader biopsychosocial approach to knee OA treatment, it has not been broadly adopted into clinical treatments. The biopsychosocial model posits that pain and disability are not only affected by pathophysical (e.g., biological) factors, but also psychological (e.g., depression, coping, self-efficacy) and social factors (e.g., social support, response of significant other).

One approach to offering psychosocial aspects in the context of pain treatment has been via CBT, a common psychosocial intervention, with evidence supporting its efficacy in OA. Despite the evidence, CBT is rarely integrated into actual clinical practice for people with knee OA. Barriers to integration have included limited access to psychologists (particularly in rural settings), difficulties coordinating primary care physicians with psychological practices, inconsistent reimbursement of psychological services for OA pain, and inconsistent standardization of treatments across settings. The current study aims to overcome barriers that have previously limited access to a biopsychosocial approach to knee OA treatments by integrating cognitive and behaviorally-based self-management training into a new rehabilitation intervention offered through occupational therapy, an allied medical field which commonly teaches behavioral strategies to improve physical function in many clinical populations. Because this approach will be manualized, it will provide the opportunity for easy adoption into clinical practice.

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 (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • community-living
  • report of at least mild to moderate pain in knee with osteoarthritis
  • clinical determination of knee osteoarthritis
  • report of knee pain for > 3 months duration
  • ambulatory with or without cane or walker
  • has internet access and can use computer

排除标准

  • severe physical impairment
  • current cancer treatment
  • knee injections or surgery in previous 3 months
  • using long-acting narcotics
  • shift workers
  • participation in rehabilitation or behavioral therapy for OA in the previous year

结局指标

主要结局

Self-Reported Physical Function-WOMAC

时间窗: 5 minutes

Western Ontario and McMaster University Arthritis Index (WOMAC) 17 items, participants rate difficulty in performing different activities on a 0 - 4 scale

次要结局

  • Pain - Brief Pain Inventory(5 minutes)
  • Objective Physical Function- 6 minute walk test(6 minutes)
  • Patient Global Impression of Change(<5 minutes)

研究者

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

Susan Murphy

Associate Professor

University of Michigan

研究点 (4)

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