Dose-Response of Manipulation for Chronic Headache

描述（由申请人提供）：有许多研究表明，脊椎推拿作为脊椎指压治疗（DC）的标志性疗法，对慢性头痛（HA）的疗效。然而，目前还没有大规模的试验来确定在治疗次数、就诊频率或治疗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，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格设计的试点研究，以评估可行性，并为R01申请的设计提供信息，以进行首次大规模试验，研究慢性HA的DC治疗数量。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指压治疗时间表。我们将研究颈源性HA，与颈部疼痛和功能障碍相关的HA。

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.