Dose-Response/Efficacy of Manipulation for Chronic LBP

描述（由申请人提供）：有许多研究支持脊椎推拿治疗腰痛（LBP）的疗效，这是脊椎指压治疗的标志性疗法。然而，目前还没有大型试验来确定在治疗次数和频率或治疗持续时间方面的最佳护理。我们的试点研究是第一个研究脊椎推拿治疗次数与腰痛缓解之间的剂量-反应关系的试验。结果显示了剂量-反应关系，并为R01应用提供了初步数据支持。这项为期5年的试验的目的是评估由脊医提供的脊柱推拿治疗机械性非特异性慢性腰痛的剂量反应、跨剂量疗效和成本效益。本研究的创新之处在于，它将调查不同治疗剂量的操作效果，以及控制注意偏差、患者期望和触摸患者的效果。这项研究意义重大，因为它将是第一个全面评估脊柱操作对疼痛和残疾结果的治疗效果的试验。它将告知基于证据的治疗方案，第三方付款人报销，以及在未来慢性腰痛试验中使用的脊椎指压治疗时间表。剂量反应研究是NCCAM战略计划的重点。研究方案的目的是在控制注意力、护理次数和双手按压后，将操作与轻度按摩进行比较。400名参与者将被随机分为4个治疗组（n = 100/组）。他们将被分配剂量（9或18次初级干预访问）和初级干预（脊柱推拿或轻按摩控制）。一个简短的，集中的光按摩将作为跨剂量疗效评估的比较疗法。所有参与者将参加18次按摩，每周3次，持续6周。所有就诊的治疗方案将标准化：评估（病史和体检）、预备热敷、初级干预（9或18次就诊）和低强度脉冲超声。仅接受9次初级干预的参与者还将接受9次注意力控制访问。包括低强度脉冲超声将控制访问的数量与某种形式的治疗。双手的放置将通过手动脊髓触诊评估的延伸来控制。具体目的是：1)确定治疗次数和不同剂量水平脊柱推拿对慢性下腰痛患者临床结局的影响；2)确定慢性下腰痛患者治疗的成本-效果和治疗次数。

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.