The safety and feasibility of transcranial direct current stimulation combined with conservative treatment for patients with cervicogenic headaches: A double-blinded randomized control study protocol

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary Clinical Trials Communications Pub Date : 2024-09-19 DOI:10.1016/j.conctc.2024.101370

K. Jobin , C. Campbell , S.M. Schabrun , K.J. Schneider , A. Smith , C.T. Debert

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Abstract

Background

Cervicogenic headaches (CGH) are common following concussion and whiplash injuries and significantly reduce patient quality of life. Conservative therapies such as ET (ET) and physiotherapy combined with injection-based therapies are cornerstones of treatment for CGH but have shown limited efficacy. Transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) has shown promise in treating other chronic pain conditions. The primary aim of this trial is to evaluate the feasibility and safety of tDCS when combined with ET for the treatment of CGH.

Methods

Adults (aged 18–65), blinded to treatment arm, will be randomized into one of two groups: active tDCS followed by ET or sham tDCS followed by ET. Transcranial direct current stimulation will be applied over M1 three times per week for 6-weeks and ET will be performed daily. The primary outcomes of this trial will be the feasibility and safety of the intervention. Feasibility will be defined as greater than 30 % recruitment, 70 % protocol adherence, and 80 % retention rate. Safety will be defined as no severe adverse events. Secondary exploratory outcomes will assess improvement in pain, strength, function, and quality of life.

Conclusions

This trial aims to demonstrate the safety and feasibility of tDCS in combination with ET for the treatment of CGH. Cervicogenic headaches can be difficult to treat contributing to significant impairments function and quality of life. Transcranial direct current stimulation is a potential novel treatment to improve health outcomes in these patients.

Registration

ClinicalTrials.gov-NCT05582616.

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经颅直流电刺激联合保守治疗颈源性头痛患者的安全性和可行性：双盲随机对照研究方案

背景颈源性头痛（CGH）是脑震荡和鞭打伤后的常见病，严重降低了患者的生活质量。ET和物理疗法等保守疗法结合注射疗法是治疗颈源性头痛的基础，但疗效有限。对初级运动皮层（M1）的经颅直流电刺激（tDCS）已显示出治疗其他慢性疼痛病症的前景。本试验的主要目的是评估经颅直流电刺激（tDCS）与ET联合治疗CGH的可行性和安全性。方法成人（18-65岁）将被随机分为两组：主动经颅直流电刺激组（active tDCS）和假经颅直流电刺激组（sham tDCS）。经颅直流电刺激将应用于 M1，每周三次，持续 6 周，ET 将每天进行。本试验的主要结果是干预的可行性和安全性。可行性的定义是招募率超过 30%，方案遵守率超过 70%，保留率超过 80%。安全性的定义是无严重不良事件发生。次要探索性结果将评估疼痛、力量、功能和生活质量的改善情况。结论这项试验旨在证明 tDCS 联合 ET 治疗颈源性头痛的安全性和可行性。颈源性头痛很难治疗，会严重影响患者的功能和生活质量。经颅直流电刺激是一种潜在的新型疗法，可改善这些患者的健康状况。RegistrationClinicalTrials.gov-NCT05582616.

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.