Exploring Integrative Medicine for Back and Neck Pain - A Pragmatic Randomized Clinical Pilot Trial

Karolinska Institutet2 个研究点分布在 1 个国家目标入组 80 人开始时间: 2004年9月最近更新: 2020年10月29日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Karolinska Institutet
入组人数: 80
试验地点: 2
主要终点: Days with pain

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Research over the last years have reported an increased popularity of complementary therapies (CTs) and an integration of CTs into mainstream medical settings, health care organizations and insurance plans. These trends may present both new challenges and new opportunities for health care provision. In Sweden and elsewhere, major challenges include the great variety and quality of CT provision within health care and a lack of national and international recommendations of how integrations of CTs with conventional care should be modelled, i.e. lack of conceptual models for delivering integrative medicine (IM). This may partly be a result of a scarce evidence base in support of IM provision within public health care services, e.g. lack of IM compared to usual care in randomised clinical trials. It remains largely unknown whether comprehensive models of IM are clinically or cost effectively different from conventional care provision.

Back and neck pain are costly, conventionally managed in primary care and two of the most common conditions treated by CTs. We have developed a comprehensive collaborative consensus model for IM adapted to Swedish primary care. The aim of this pilot study was to explore the feasibility of a pragmatic randomised clinical trial to investigate the effectiveness of the IM model versus conventional primary care in the management of patients with non-specific back/neck pain.

详细描述

Study objectives included the exploration of recruitment and retention rates, patient and care characteristics, clinical differences and effect sizes between groups, selected outcome measures and power calculations to inform the basis of a full-scale trial.

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: None

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Back/neck pain with or without headache for at least two weeks and at least three times per week
•Resident of Stockholm County
•Literate in Swedish
•Willing and able to comply with study requirements

排除标准

•Specific pathology and severe causes of back/neck pain such as malignant disease, vertebral fractures and severe or progressive neurological symptoms.