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临床试验/NCT01147120
NCT01147120已完成不适用

CAM Referral and Outcomes: Chronic Low Back Pain in Urban and Rural Primary Care

William G Elder JR2 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2009年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
138
试验地点
2
主要终点
Oswestry Disability Index (ODI)

研究概览

简要总结

Kentucky ranks 2nd in disability among states, with chronic low back pain (CLBP) as a major disability, especially in the investigators rural areas. Kentucky and U.S. health care providers need alternative and effective treatments. Following NCCAM strategic research recommendations, this study will investigate health services outcomes of complementary and alternative medicine (CAM) therapies in an existing primary care practice-based research network (PBRN). The Patients with CLBP are often willing to try therapeutic options outside the conventional medical spectrum. Massage and relaxation therapies have demonstrated fairly good efficacy in controlled trials but their effectiveness in the "real world" of primary care is only beginning to be evaluated. The long-term goal of the proposed project builds on the foundation of these two established therapies to improve treatment of chronic low back pain (CLBP) in primary care practices. Two alternative (CAM) therapies, progressive muscle relaxation (PMR) and clinical massage therapy (CMT), will be studied. The short-term objectives of the proposed project are to: (1) examine outcomes of CAM for patients with CLBP referred from primary care practices, and (2) better understand physician decision-making to recommend CAM therapy for CLBP. Specific Aim 1 will evaluate improvement in health-related outcomes for patients with CLBP when referred to PMR or CMT from primary care. Specific Aim 2 will explore selected factors in primary care physicians' decisions to recommend CAM therapy to these patients. The proposed study is unique in that it addresses "real life" clinical situations and decision-making in both urban and rural clinical practices within an existing PBRN. Should such CAM referral prove successful for ameliorating CLBP, it would provide relatively low cost, non-addictive treatment options for inclusion in the repertoire of primary care physicians.

详细描述

The proposed study will investigate health related outcomes of two CAM treatments recommended by primary care physicians for CLBP, and explore selected elements in the decision process to recommend or not recommend one of two CAM treatments.

Patients and primary care physicians (PCPs) will participate from metropolitan and nonmetropolitan central Kentucky practices of the Kentucky Ambulatory Network (KAN), Kentucky's statewide primary care practice-based research network (PBRN). Each practice will have a patient participant enrollment period of four weeks. Patients with CLBP who have a visit during the enrollment period in a practice may be eligible to participate in the study, and participating PCPs will be invited to recommend as many eligible patients as they feel comfortable. During patient visits, the PCP may offer a recommendation to the patient to receive PMR or CMT. Patients who agree will be recruited by the KAN/CAM project team staff. Patients who enroll in the CAM recommendation study will receive a 12-week course of PMR or CMT treatments. Outcomes will be measured at three time points: baseline, 12 weeks, and 24 weeks.

研究设计

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

入排标准

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

入选标准

  • Have a visit with the physician during the 4-week study referral period for that practice
  • Be 21 years of age or older on the date of the visit
  • According to the physician, currently have CLBP
  • Have been a patient in the practice for at least 3 months
  • Have a life expectancy of 6 months or more

排除标准

  • Not have a current or past history of psychosis
  • Not be pregnant

结局指标

主要结局

Oswestry Disability Index (ODI)

时间窗: Baseline, 12 Weeks, and 24 Weeks

Survey completed at Baseline, 12 Weeks, and 24 Weeks

Short Form 36 (SF-36)

时间窗: Baseline, 12 Weeks, and 24 Weeks

Health related quality of life survey

Faces Pain Scale - Revised (FPS-R)

时间窗: Baseline, 12 Weeks, and 24 Weeks

Survey

次要结局

  • Pain Medication Questionnaire (PMQ) - subset(Baseline, 12 Weeks, and 24 Weeks)
  • Expectations for and Satisfaction with Therapies(Baseline and 12 Weeks)
  • Tampa Scale of Kinesiophobia (TSK) - Subset(Baseline, 12 Weeks, and 24 Weeks)
  • Patient Perceptions of CAM Therapy(Baseline, 12 Weeks, and 24 Weeks)
  • Physician Perceptions of CAM Therapy(Baseline)
  • Physician Point-of-Care Card(4 weeks per practice (Identify and screen for possible patients))

研究者

发起方
William G Elder JR
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

William G Elder JR

Principal Investigator

University of Kentucky

研究点 (2)

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