The Safety and Feasibility of Transcranial Direct Current Stimulation Combined With Conservative Treatment for Cervicogenic Headaches
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Safety of tDCS through adverse events and transient changes in adverse effects within each tDCS session.
研究概览
简要总结
Annually, up to 150,000 individuals are affected by cervicogenic headaches (CGH) in Canada with many of these cases being chronic. Current treatments for CGH are limited in efficacy and durability - indicating a dire need for novel interventions in this population. Transcranial direct current stimulation (tDCS) and physiotherapy have a high degree of safety and have been studied as interventions for many other chronic pain conditions and headache disorders. We propose to study the feasibility and safety of tDCS alongside physiotherapy for CGH further in a randomized sham controlled trial.
详细描述
Annually, up to 150,000 people in Canada and experience cervicogenic headaches (CGH) with many of these patients suffering from chronic CGH. CGH is a pain disorder where pain is perceived in the head but caused by dysfunction of the cervical spine and its anatomical structure. More specifically, the pathogenesis of CGH is due to the convergence of nociceptive afferents from the upper three cervical nerves and trigeminal nerves onto second-order neurons in the trigeminocervical nucleus. The pain signaling resulting from this is also modulated through sensorineural pathways involving the thalamus and the sensorimotor cortex. As such symptoms of CGH include restricted movement, local tenderness of the upper cervical spine joints, musculoskeletal impairments, headache, local pressure hyperalgesia and bilateral thermal hypoesthesia. To date, there is no "cure" for chronic CGH and current treatment entails trial and error with behavior management, environmental modifications and medications. Consequently, there is a significant need for new approaches to symptom management in order to help improve functional impairment and disease burden associated with treating CGH. Transcranial direct current stimulation (tDCS) and physiotherapy have a high degree of safety and have been studied as an intervention for many other chronic pain conditions and headache disorders, including arthritis and migraines, demonstrating considerable potential. The investigators propose to study the safety and feasibility of tDCS alongside physiotherapy as a treatment for CGH in a randomized sham controlled trial.
RESEARCH QUESTIONS AND OBJECTIVES
The overall objective is to study the feasibility and safety of tDCS applied to the primary motor cortex in patients with CGH and to explore whether active tDCS augments the effect of rehabilitation therapy.
Specifically the objectives are:
Primary Objective: To determine whether active tDCS is feasible and safe compared to sham when administered with rehabilitation therapy for patients with CGH when administered 3 times per week over the course of 6 weeks. Safety will be measured through serious adverse events (defined as events requiring medical attention). Feasibility will be measured by recruitment (greater than 30%), retention (greater than 80%), and adherence (greater than 70%). These outcomes will be measured throughout the treatment process up to immediately post-treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, researcher, and care providers will be blinded until after the analysis period, researchers will be assessing outcomes.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with cervicogenic headaches based on International Headache Society Guidelines lasting greater than 12 weeks
- •The International Headache Society Guidelines are as follows: A) Presence of a headache fulfilling criterion C; B) Clinical and/or imaging evidence of a disorder or lesion within the cervical spine or soft tissues of the neck, known to be able to cause headache; C) Evidence of causation demonstrated by at least two of the following: (a) Headache has developed in temporal relation to the onset of the cervical disorder or appearance of the lesion; (b) Headache has significantly improved or resolved in parallel with improvement in or resolution of the cervical disorder or lesion; (c) Cervical range of motion is reduced and headache is made significantly worse by provocative maneuvers; (d) Headache is abolished following diagnostic blockade of a cervical structure or its nerve supply.
- •Average pain score ≥ 4/10 and Neck Disability score ≥ 28/50
排除标准
- •Known cervical spine pathology (such as tumours or fractures)
- •Nerve root pain/sensory loss
- •Muscular or joint inflammatory conditions
- •Neurological or psychiatric conditions
- •Undergone recent surgery (within prior year)
- •Have contraindications to tDCS (metal or electronic implants in the brain/skull; metal or electronic implants in other sites on the body; surgical procedures involving the head or spinal cord; skin problems such as dermatitis, psoriasis or eczema; epilepsy or a previous convulsion/seizure; fainting spells or syncope; pregnancy or any chance of pregnancy; previous electrical or magnetic stimulation)
结局指标
主要结局
Safety of tDCS through adverse events and transient changes in adverse effects within each tDCS session.
时间窗: To be assessed throughout the 6 weeks of treatment up to the post-treatment follow-up.
The safety of tDCS will primarily be measured through tracking rates of serious adverse effects (defined as events requiring medical attention), to be considered safe we expect 0 events of this nature to occur. Additionally, changes in safety questionnaire scores tracking transient within-session changes were considered. Safety questionnaires ask participants to rate commonly experienced symptoms from 0-100 (0= "Not occurring", 100 = "Most severe"). The symptoms assessed are itchiness, tingling, burning sensations, headache, fatigue, nausea, and mood difficulties.
Craniocervical Flexion Test (CCFT)
时间窗: To be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment.
Fine motor control of neck muscles will be measured via the Craniocervical Flexion Test (CCFT).
Feasibility of tDCS through recruitment rate, retention rate in the study, and adherence rates to both tDCS and exercise therapy.
时间窗: To be assessed throughout the 6 weeks of treatment and at post-treatment follow-up.
The feasibility of tDCS will be measured through the rate of participants contacted vs those actually enrolled (expected to be greater than 30%), through rate of those enrolled vs those completing 6-weeks of treatment (expected to be greater than 80% retained), and through rates of those who completed all 18 tDCS sessions in 6-weeks as well as the percentage of exercise therapy sessions completed within the 6-week study period (expected to be greater than 70% for both).
次要结局
- Numeric Pain Rating Scale (NPRS)(To be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment.)
- Headache Disability Index (HDI)(To be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment.)
- PROMIS Pain Interference Scale(To be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment.)
- Cervical Extensor Endurance Test (CEET)(To be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment.)
- European Quality of Life Five Dimension (EQ-5D)(To be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment.)
- Pain Catastrophizing Scale (PCS)(To be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment.)
- Patient health questionnaire 9 (PHQ-9)(To be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment.)
- Manual Examination of Cervical Joints (MECJ)(To be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment.)
- Headache Impact Test 6 (HIT-6)(To be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment.)
- Dynamometry Neck-Strength Assessment (DNSA)(To be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment.)
- Cervical Flexor Endurance Test (CFET)(To be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment.)
- Range of Motion of Cervical Joints (ROM)(To be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment.)
- Generalized anxiety disorder scale 7 (GADS-7)(To be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment.)