Dose-Response of Manipulation for Chronic Headache

描述(申请人提供)：已有多项研究表明脊柱手法对慢性头痛(HA)的疗效，脊椎手法是脊椎按摩(DC)护理的标志性疗法。然而，还没有大型试验来确定治疗次数、就诊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)，初步评估在固定时间段内多次治疗对头痛结果的影响。这项试验表明，通过更多的治疗，可以显著减少疼痛、残疾和头痛的数量。因此，我们建议进行一项严谨设计的先导研究，以评估可行性，并为R01申请的设计提供资料，以进行首次大规模的DC治疗治疗慢性医管局试验。长期目标是为循证治疗方案、第三方付款人报销和未来试验中使用的脊椎护理时间表提供信息。我们将研究颈源性HA，HA与颈部疼痛和功能障碍有关。 我们的试点将是创新的，因为它将调查DC为治疗头痛而进行的操作的剂量反应和有效性，以及控制注意力偏差和患者预期。总共80名参与者将被随机分成4个治疗组(n=20/组)。他们将被随机分成剂量(8或16个治疗)和治疗(脊柱推拿或轻按摩对照)。由按摩治疗师提供的轻柔按摩将作为疗效评估的对比疗法。为了控制注意力(包括同情和举手)，所有参与者将接受16次探视(2次/周，为期8周)；仅接受8次治疗的人还将接受8次探视以进行功能评估和一只同情的耳朵。 主要结果将是在随机分组后12周和24周评估HA疼痛、残疾和频率。主要结果是12周时出现HA疼痛。 有两个具体目标。首先是获取设计大型临床试验的信息，并确定其可行性。第二项是估计剂量和疗效参数，用于一项更大规模的研究，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.