Dose-Response of Manipulation for Chronic Headache

描述（由申请人提供）：已经有许多研究表明脊柱推拿的疗效，脊椎按摩（DC）护理的签名疗法，慢性头痛（HA）。然而，还没有大型试验来确定治疗次数，办公室访问频率或护理持续时间方面的最佳护理。作为第一步，我们进行了一项小型随机试验（n = 24），以初步评估在固定时间内治疗次数对头痛结局的影响。该试验表明，通过大量的治疗，疼痛、残疾和头痛的数量得到了重要的减少。因此，我们提出了一个严格设计的试点研究，以评估的可行性，并告知设计的R 01应用程序的第一个大规模试验的数量DC治疗慢性HA的护理。长期目标是告知循证治疗方案，第三方付款人报销，以及未来试验中使用的脊椎按摩治疗时间表。我们将研究颈源性HA，HA与颈部疼痛和功能障碍的关系。 我们的试点将是创新的，因为它将调查的剂量反应和疗效的操作进行的DC头痛的护理，以及控制注意力偏差和病人的期望。共80例受试者将随机分配至4个治疗组（n = 20/组）。他们将被随机分配至剂量（8或16次治疗）和治疗（脊柱推拿或轻度按摩对照）。由按摩治疗师提供的轻度按摩将作为疗效评估的比较疗法。为了控制注意力（包括同情和按手），所有受试者将接受16次访视（2次/周，共8周）;仅接受8次治疗的受试者还将接受8次功能评估和同情耳访视。 主要结局将是随机分组后12周和24周评价的HA疼痛、残疾和频率。主要结局为12周时的HA疼痛。 有两个具体目标。第一是获取设计大型临床试验的信息，并确定其可行性。第二个是估计剂量和疗效参数的一个更大的研究，以确定颈源性头痛的结果与治疗次数的关系。

DESCRIPTION (provided by applicant): There have been a number of studies suggesting the efficacy of spinal manipulation, the signature therapy of chiropractic (DC) care, for chronic headache (HA). Yet, there have been no large trials to determine optimal care in terms of the number of treatments, frequency of office visits, or duration of care. As a first step, we conducted a small randomized trial (n = 24) to make a preliminary evaluation of the effect on headache outcomes of the number of treatments in a fixed time period. The trial suggested important reduction of pain, disability, and number of headaches with a larger number of treatments. We thus propose a rigorously designed pilot study to assess the feasibility and inform the design of an R01 application for the first large-scale trial on the number of DC treatments for the care of chronic HA. The long-range goals are to inform evidence-based treatment protocols, third-party payer reimbursement, and schedules of chiropractic care used in future trials. We will study cervicogenic HA, HA related to neck pain and dysfunction. Our pilot will be innovative in that it will investigate both dose-response and efficacy of manipulation performed by DCs for the care of headache, as well as control attention bias and patient expectation. A total of 80 participants will be randomized to 4 treatment groups (n = 20/group). They will be randomized to dose (8 or 16 treatments) and to therapy (spinal manipulation or light massage control). Light massage, provided by a massage therapist, will serve as the comparison therapy for efficacy assessment. To control attention (including sympathy and the laying on of hands), all participants will have 16 visits (2/wk for 8 wk); those receiving only 8 treatments will also receive 8 visits for functional assessment and a sympathetic ear. Principal outcomes will be HA pain, disability and frequency evaluated at 12 and 24 weeks after randomization. The primary outcome will be HA pain at 12 weeks. There are two specific aims. The first is to acquire information for designing a large clinical trial and determine its feasibility. The second is to estimate dose and efficacy parameters for a larger study for determining the relationship of cervicogenic headache outcomes with the number of treatments.