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Dose-Response/Efficacy of Manipulation for Chronic LBP

慢性腰痛治疗的剂量反应/疗效

基本信息

批准号：
7920234
负责人：
Mitchell Haas
金额：
$ 46.52万
依托单位：
UNIVERSITY OF WESTERN STATES
依托单位国家：
美国
项目类别：
财政年份：
2006
资助国家：
美国
起止时间：
2006-09-01 至 2013-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7920234
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

项目摘要

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）：已有大量研究支持脊柱推拿疗法（脊椎按摩疗法的标志性疗法）对于腰痛 (LBP) 的疗效。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的最佳护理。我们的初步研究是第一个调查脊柱手法治疗次数与腰痛缓解之间剂量反应关系的试验。结果表明了剂量反应关系，并提供了支持 R01 应用的初步数据。我们为期 5 年的试验的目的是评估脊椎按摩师提供的脊柱手法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。这项研究的创新之处在于，它将调查治疗剂量的操纵效果，以及控制注意力偏差、患者期望和触摸患者的影响。其意义重大，因为这将是第一个全面的试验，评估脊柱手法治疗次数对疼痛和残疾结果的影响。它将为未来慢性腰痛试验中使用的循证治疗方案、第三方付款人报销以及脊椎按摩治疗时间表提供信息。剂量反应研究是 NCCAM 战略计划的优先事项。该研究方案旨在比较控制注意力后的剂量、护理次数和按手次数后的手法与轻度按摩。总共 400 名参与者将被随机分为 4 个治疗组（n = 100/组）。他们将被分配到剂量（9 或 18 次初级干预就诊）和初级干预（脊柱推拿或轻度按摩控制）。简短、集中的轻按摩将作为评估不同剂量疗效的比较疗法。所有参与者将参加脊椎按摩师的 18 次疗程：每周 3 次，持续 6 周。所有就诊的治疗方案都将标准化：评估（病史和体格）、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 次主要干预治疗的参与者还将接受 9 次注意力控制访问。纳入低强度脉冲超声将控制某种形式治疗的就诊次数。手的放置将通过手动脊柱触诊评估的扩展来控制。具体目标是：1) 确定不同剂量水平的治疗次数和脊柱手法疗效对慢性腰痛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腰痛的治疗次数。