Dose-Response/Efficacy of Manipulation for Chronic LBP

慢性腰痛治疗的剂量反应/疗效

• 批准号: 7679524
• 负责人: Mitchell Haas
• 金额: $ 52.26万
• 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/7679524
• 关键词: Attention; Blinded; Caring; Chiropractor; Chronic low back pain; Clinical; Data; Dose; Evidence based treatment; Frequencies; Future; Home environment; Intervention; Investigation; Laying-on-of-Hands; Light; Low Back Pain; Manuals; Massage; Mechanics; Monitor; National Center for Complementary and Alternative Medicine; Outcome; Pain; Palpation; Participant; Patients; Pattern; Physiologic pulse; Pilot Projects; Placebo Effect; Protocols documentation; Provider; Randomized; Recording of previous events; Relative (related person); Research; Research Design; Research Personnel; Schedule; Spinal; Spinal Manipulation; Strategic Planning; Third-Party Payer; Touch sensation; Treatment Efficacy; Treatment Protocols; Ultrasonography; Visit; chiropracty; cost; cost effectiveness; design; disability; functional disability; innovation; patient expectation; primary outcome; programs; response

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(申请人提供)：已经有许多研究支持脊柱手法的疗效，脊柱手法是脊椎按摩护理的标志性疗法，用于治疗下腰痛(LBP)。然而，还没有大型试验来确定治疗的次数和频率或护理持续时间方面的最佳护理。我们的先导性研究是第一次调查脊柱手法治疗次数与LBP缓解之间的剂量-反应关系。研究结果表明了剂量-反应关系，并为R01的应用提供了初步数据。我们为期5年的试验的目的是评估脊椎推拿治疗机械性非特异性慢性下腰痛的剂量反应、跨剂量疗效和成本效益。这项研究的创新之处在于，它将调查不同治疗剂量的操作效果，以及控制注意力偏差、患者期望和触摸患者的效果。意义重大的是，这将是第一次全面评估脊柱手法治疗对疼痛和残疾结果的影响。它将告知循证治疗方案、第三方付款人报销，以及未来慢性下腰痛试验中使用的脊椎护理时间表。剂量-反应研究是NCCAM战略计划的优先事项。该研究方案旨在将手法与在控制注意力、关怀的就诊次数和手放在一起后的轻按摩进行比较。总共400名参与者将被随机分为4个治疗组(n=100个/组)。他们将被分配到剂量(9或18次初级干预访问)和初级干预(脊柱推拿或轻按摩对照)。一次简短的聚焦光按摩将作为跨剂量疗效评估的对比疗法。所有参与者将与脊椎按摩师一起参加18个疗程：每周3次，为期6周。所有就诊的治疗方案将标准化：评估(病史和体检)、准备热包、初步干预(9次或18次)和低强度脉冲超声波。只接受9次初级干预的参与者也将有9次注意力控制访问。低强度脉冲超声波的加入将通过某种形式的治疗来控制就诊次数。将通过延长人工脊椎触诊评估来控制手的放置。其具体目标是：1)确定不同剂量水平的脊柱手法的治疗次数和疗效对慢性LBP患者临床结果的影响；2)确定脊柱手法的成本效益和治疗慢性LBP的治疗数量。