Dose-Response/Efficacy of Manipulation for Chronic LBP

慢性腰痛治疗的剂量反应/疗效

• 批准号: 7149673
• 负责人: Mitchell Haas
• 金额: $ 53.78万
• 依托单位: UNIVERSITY OF WESTERN STATES
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-01 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7149673
• 关键词: attention; backache; clinical research; cost effectiveness; hand; health care personnel; lighting; ultrasound

DESCRIPTION (provided by applicant): There have been a number of studies supporting the efficacy of spinal manipulation, the signature therapy of chiropractic care, for low back pain (LBP). Yet, there have been no large trials to determine optimal care in terms of the number and frequency of treatments, or duration of care. Our pilot study was the first trial to investigate a dose-response relationship between the number of treatments with spinal manipulation and relief of LBP. The results indicate a dose-response relationship and provide preliminary data in support of this R01 application. The purpose of our 5-year trial is to evaluate dose-response, efficacy across dose, and cost-effectiveness of spinal manipulation provided by chiropractors for the treatment of nonspecific, chronic low back pain of mechanical origin. This study is innovative in that it will investigate efficacy of manipulation across treatment dose, as well as control attention bias, patient expectation, and the effects of touching the patient. It is significant in that it will be the first full-scale trial evaluating the effects of the number of treatments with spinal manipulation on pain and disability outcomes. It will inform evidence- based treatment protocols, third-party payer reimbursement, and schedules of chiropractic care used in future trials on chronic LBP. The study of dose-response is a priority in the NCCAM strategic plan. The study protocol is designed to compare manipulation to a light massage across dose after controlling attention, number of visits with care rendered, and the laying on of hands. A total of 400 participants will be randomized to 4 treatment groups (n = 100/group). They will be allocated to dose (9 or 18 primary- intervention visits) and to primary intervention (spinal manipulation or light massage control). A brief, focused light massage will serve as the comparison therapy for the assessment of efficacy across dose. All participants will attend 18 sessions with a chiropractor: 3 visits per week for 6 weeks. The treatment protocols will be standardized for all visits: assessment (history and physical), preparatory hot pack, primary intervention (9 or 18 visits), and low-intensity pulsed ultrasound. Participants receiving only 9 sessions for a primary intervention will also have 9 attention control visits. The inclusion of low-intensity pulsed ultrasound will control the number of visits with some form of treatment. The laying on of hands will be controlled by extension of the manual spinal palpation assessment. The specific aims are: 1) to determine the effect of the number of treatments and the efficacy of spinal manipulation across dose levels on clinical outcomes for chronic LBP sufferers, and 2) determine the cost- effectiveness of spinal manipulation and the number of treatments for the care of chronic LBP.

描述（由申请人提供）：已经有许多研究支持脊柱推拿的疗效，脊椎按摩疗法的签名治疗，腰痛（LBP）。然而，还没有大型试验来确定治疗次数和频率或护理持续时间方面的最佳护理。我们的初步研究是第一个调查脊柱推拿治疗次数与LBP缓解之间剂量反应关系的试验。结果表明存在剂量-反应关系，并提供了支持R 01应用的初步数据。我们5年试验的目的是评估剂量反应，疗效跨剂量，和成本效益的脊椎推拿治疗非特异性，慢性腰痛的机械性起源提供的脊椎。这项研究的创新之处在于，它将调查在治疗剂量范围内操作的有效性，以及控制注意力偏差，患者期望和触摸患者的影响。它的重要性在于，它将是第一个评估脊柱推拿治疗次数对疼痛和残疾结果影响的全面试验。它将告知循证治疗方案，第三方付款人报销，以及在未来的慢性腰痛试验中使用的脊椎按摩治疗时间表。剂量反应研究是NCCAM战略计划的优先事项。该研究方案旨在将控制注意力后的不同剂量的手法与轻度按摩进行比较，提供护理的访视次数和手的放置。共400例受试者将随机分配至4个治疗组（n = 100/组）。他们将被分配到剂量（9或18次主要干预访视）和主要干预（脊柱推拿或轻度按摩控制）。简短、集中的光按摩将作为比较治疗，用于评估各剂量的疗效。所有参与者将参加18个会议与脊椎按摩师：每周3次访问，为期6周。所有访视的治疗方案都将标准化：评估（病史和体格检查）、准备性热敷、主要干预（9或18次访视）和低强度脉冲超声。仅接受9次主要干预的参与者也将接受9次注意力控制访视。纳入低强度脉冲超声将控制某种形式治疗的就诊次数。将通过扩展手动脊柱触诊评估来控制手的放置。具体目标是：1）确定治疗次数的影响和剂量水平上脊柱推拿对慢性LBP患者临床结果的功效，以及2）确定脊柱推拿的成本效益和治疗慢性LBP的治疗次数。