Moustafa Ibrahim M, Diab Aliaa, Shousha Tamer, Harrison Deed E
Department of Physiotherapy, College of Health Sciences, University of Sharjah, United Arab Emirates.
Faculty of Physical Therapy, Cairo University, Giza, Egypt.
Heliyon. 2021 Mar 15;7(3):e06467. doi: 10.1016/j.heliyon.2021.e06467. eCollection 2021 Mar.
To investigate the feasibility and effect of a multimodal program for improving chronic cervicogenic headache (CGH) via the addition of sagittal cervical spine alignment correction.
Pilot, parallel-group, randomized controlled trial.
60 patients with CGH, straightening of the cervical lordosis, and forward head posture (FHP) were randomly assigned using permuted-block randomization either to a control (n = 30) or an experimental group (n = 30).
Subjects in both groups received a multimodal program where the denneroll cervical spine extension traction orthotic was added to the experimental group only. Feasibility was assessed through recruitment rate, compliance rate, adherence rate, safety, and global satisfaction in addition to clinical outcome measures: FHP distance, cervical lordosis, headache frequency, headache disability inventory (HDI), headache impact test-6 (HIT-6), and daily defined dose (DDD). Evaluations were performed at: baseline, 10 weeks, 1 year follow up, and 2-year follow up. The assessor was blind to group allocation for all measured outcomes.
The recruitment rate was 60%, 78 % out of them completed the entire study. The recruited participants complied with 98% of the required visits. No adverse events were recorded and greater overall satisfaction with the interventions was reported. Greater improvements were found for the experimental group's cervical lordosis (f = 259.9, < < .001) and FHP (f = 142.5, < < .001). At 10 weeks, both groups showed equal improvements in CGH outcomes: headache frequency ( = 0.07), HDI ( = 0.07), HIT-6 (P = .2), and DDD (P = .3). In contrast, at the 1-year and 2-year follow up, between group differences were found for all CGH outcomes, < .00, indicating greater improvement in the experimental group.
The results indicated feasibility for recruitment rate, compliance rate, exercise session adherence, safety, and global satisfaction. At 1-year and 2-year follow-up, the addition of the denneroll orthotic device revealed positive influence on CGH management outcomes.
The trial was retrospectively registered with the Pan African Clinical Trial Registry (PACTR201605001650300).
通过增加矢状位颈椎排列矫正来研究多模式方案改善慢性颈源性头痛（CGH）的可行性和效果。
试点、平行组、随机对照试验。
60例患有CGH、颈椎生理前凸变直和头前倾姿势（FHP）的患者，采用置换区组随机化方法随机分为对照组（n = 30）或试验组（n = 30）。
两组受试者均接受多模式方案，试验组在此基础上仅增加丹诺枕颈椎伸展牵引矫形器。除临床结局指标（FHP距离、颈椎生理前凸、头痛频率、头痛残疾评定量表（HDI）、头痛影响测试-6（HIT-6）和日限定剂量（DDD））外，还通过招募率、依从率、坚持率、安全性和总体满意度评估可行性。在基线、10周、1年随访和2年随访时进行评估。所有测量结局的评估者均对分组情况不知情。
招募率为60%，其中78%完成了整个研究。招募的参与者98%遵守了所需的就诊安排。未记录到不良事件，且报告对干预措施的总体满意度更高。试验组的颈椎生理前凸（f = 259.9，P << .001）和FHP（f = 142.5，P << .001）改善更明显。在10周时，两组在CGH结局方面显示出同等程度的改善：头痛频率（P = 0.07）、HDI（P = 0.07）、HIT-6（P = .2）和DDD（P = .3）。相比之下，在1年和2年随访时，所有CGH结局在组间均存在差异，P < .00，表明试验组改善更明显。
结果表明在招募率、依从率、锻炼课程坚持率、安全性和总体满意度方面具有可行性。在1年和2年随访时，增加丹诺枕矫形器对CGH管理结局显示出积极影响。
该试验在泛非临床试验注册中心（PACTR201605001650300）进行了回顾性注册。
