Nambi Gopal, Alghadier Mshari, Khanam Humaira, Pakkir Mohamed Shahul Hameed, Aldhafian Osama R, Alshahrani Naif A, Mani Paramasivan, Chevidikunnan Mohamed Faisal, Khan Fayaz, Albarakati Alaa Jameel A
Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia.
Department of Physical Therapy, Faculty of Applied Medical Sciences, University of Tabuk, Tabuk, Saudi Arabia.
Pain Ther. 2024 Dec;13(6):1679-1693. doi: 10.1007/s40122-024-00671-w. Epub 2024 Oct 28.
There is a multitude of evidence supporting the use of manual and manipulative therapy techniques for patients with cervicogenic headache (CGH). However, evidence in finding and comparing the efficacy of instrument assisted soft tissue mobilization with manual therapy in unilateral cervicogenic headache is lacking. Therefore, the objective of the study is to find and compare the long term effects of instrument assisted soft tissue mobilization along with spinal manipulation therapy in patients with cervicogenic headache.
It is a randomized, single-blinded controlled study conducted at University hospital. Overall, 64 participants with CGH were divided into spinal manipulation therapy group (SMT; n = 32) and spinal manipulation therapy with instrument assisted soft tissue mobilization (ISM) group (SMT + ISM; n = 32) and they received the respective treatment for 4 weeks. In addition, both groups received 10 min of heat therapy and neck isometric exercises three times a day. The primary (CGH frequency) and secondary (CGH pain intensity, CGH disability neck pain frequency, pain intensity, pain threshold, neck disability index and quality of life) scores were measured at baseline, after 4 weeks, and at 6 months.
The reports of the SMT and SMT + ISM group were compared. Following 4 weeks of training, and at 6 months follow up the SMT + ISM group showed more significant changes in the primary outcome (CGH frequency) with a -4.3 [(95% confidence interval (CI) -4.80 to -3.79] and -1.7 (95% CI -1.92 to -1.47), when compared with the SMT group alone (p = 0.001). The secondary outcomes (CGH pain intensity, CGH disability, neck pain frequency, neck pain intensity, neck disability index, and quality of life) also shows more significant changes in the SMT + ISM group than the SMT group (p = 0.001). The same gradual improvement can be seen in the above variables at 6 months follow up. At the same time, neck pain threshold level does not show any improvement at 4 weeks (p ≥ 0.05) but shows a statistical difference at 6 months follow up. No such adverse effects or consequences were noted during or after the intervention.
The study concluded that spinal manipulation therapy with instrument assisted soft tissue mobilization provided better long-term outcomes in patients with cervicogenic headache. This study provided a piece of sound physical therapy evidence for a widespread and costly clinical condition, such as cervicogenic headache.
The trial was registered prospectively in the Indian clinical trial registry with CTRI/2020/06/026243 on 30/06/2020.
有大量证据支持对颈源性头痛（CGH）患者使用手法和整复治疗技术。然而，在单侧颈源性头痛中，缺乏关于寻找和比较器械辅助软组织松动术与手法治疗疗效的证据。因此，本研究的目的是寻找并比较器械辅助软组织松动术联合脊柱整复疗法对颈源性头痛患者的长期影响。
这是一项在大学医院进行的随机、单盲对照研究。总体而言，64名CGH参与者被分为脊柱整复治疗组（SMT；n = 32）和脊柱整复治疗联合器械辅助软组织松动术（ISM）组（SMT + ISM；n = 32），他们接受了为期4周的相应治疗。此外，两组均接受每天3次、每次10分钟的热疗和颈部等长运动。在基线、治疗4周后和6个月时测量主要（CGH频率）和次要（CGH疼痛强度、CGH功能障碍、颈部疼痛频率、疼痛强度、疼痛阈值、颈部功能障碍指数和生活质量）评分。
比较了SMT组和SMT + ISM组的报告。经过4周的训练，以及在6个月的随访中，SMT + ISM组在主要结局（CGH频率）上显示出更显著的变化，分别为-4.3[（95%置信区间（CI）-4.80至-3.79]和-1.7（95%CI -1.92至-1.47），而单独的SMT组为（p = 0.001）。次要结局（CGH疼痛强度、CGH功能障碍、颈部疼痛频率、颈部疼痛强度、颈部功能障碍指数和生活质量）在SMT + ISM组中也比SMT组显示出更显著的变化（p = 0.001）。在6个月的随访中，上述变量也呈现出相同的逐渐改善。同时，颈部疼痛阈值水平在4周时未显示任何改善（p≥0.05），但在6个月的随访中显示出统计学差异。在干预期间或之后未观察到此类不良反应或后果。
该研究得出结论，脊柱整复治疗联合器械辅助软组织松动术为颈源性头痛患者提供了更好的长期疗效。本研究为颈源性头痛这种广泛且代价高昂的临床病症提供了可靠的物理治疗证据。
该试验于2020年6月30日在印度临床试验注册中心进行前瞻性注册，注册号为CTRI/2020/06/026243。
