Investigation of the Effects of Transcranial Direct Current Stimulation Combined With Stabilization Exercises on Functional Status, Cognitive Functions, and Sleep Quality in Individuals With Chronic Neck Pain: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 3
- 主要终点
- Assessment of Muscular Endurance
研究概览
简要总结
The aim of study was to investigate the effect of cervical stabilization exercises (CSE) combined with tDCS on functional status, cognitive functions and sleep quality in individuals with chronic neck pain. A total of 29 individuals with chronic neck pain (33.06±14.81 age) were included in the study. Combined CSE with tDCS (2 mA/20 min) was applied to the experimental group (n=10); only CSE was applied to the control group (n=10); placebo tDCS (0 mA/20 min) and CSE were applied to the sham group (n=9). Before and after the 8-week intervention comprising a total of 16 sessions, the following assessments were carried out: Visual Analog Scale (VAS), Neck Bournemouth Questionnaire (NBQ), Cervical Muscle Endurance Tests, The Profile Fitness Mapping Neck Questionnaire (ProFitMap-neck), Montreal Cognitive Assessment (MoCA), Trail Making Test (TMT) and Pittsburgh Sleep Quality Index (PSQI).
详细描述
This study was conducted at Erciyes University Faculty of Sports Sciences with individuals suffering from chronic neck pain. The study included a total of 29 individuals with chronic neck pain, grouped into experimental, control, and sham groups. The flowchart in Figure 1 illustrates the distribution of individuals within each group.
The present study was conducted with individuals between 18 and 65 years of age who had suffered from neck pain for at least 3 months, with a rest pain score of 3-7 on the "Visual Analog Scale", without neurological deficits and without pathological findings (fractures, dislocations, tumors, infections) in radiological tests. In addition, neurological or psychiatric disorders, including acute/chronic depression, history of head trauma resulting in loss of consciousness, epilepsy, history of neurosurgical intervention, intracranial hypertension, implanted devices, history of migraine, history of chronic/severe headache, skin conditions (psoriasis, etc.), uncontrollable diseases (endocrinologic, cardiovascular, pulmonary, hematologic, hepatic, renal), presence of systemic inflammatory disease or malignancy, were excluded from the study.
Potential Confounders Gender, age, body mass index, smoking history, presence of back pain in the previous six months, chronic illness, and resting neck pain severity were considered potential confounders.
Study Design Cervical stabilization exercises (CSE) (20 min) with tDCS (2 mA) were administered to the experimental group of the study (n=10) for 20 min. Only CSE (20 min) was applied to the control group (n=10). To the Sham group (n=9); CSE (20 min) was administered with 20 min tDCS (0 mA). All cervical stabilization exercises were performed with a stabilizer biofeedback device (Stabilizer Pressure Biofeedback, Chattanooga Group Inc., USA) under the supervision of a physiotherapist. All groups were trained for a total of 16 sessions over 8 weeks (2 days/week).
Intervention Transcranial Direct Current Stimulation (tDCS) tDCS was administered using electrodes made of metal or conductive rubber, an electrode sponge, and an electrolyte-based contact medium applied to the sponge (6 ml of water for a 35 cm2 sponge). 'Chatanooga Ionto Iontophoresis Dual Channel System (USA)' was used in the study as a constant current stimulator for tDCS. The constant current stimulator was used to deliver the direct current in a constant manner by monitoring the resistance in the continuous system. Two electrodes were placed at 5 cm × 7 cm; 35 cm2; an anode was placed in the primary motor cortex (M1), while a cathode was placed in the contralateral supraorbital space (FP1 on the left and FP2 on the right, according to the EEG 10/20 system). As shown in the figure, a constant current of 2 mA was applied to the experimental group for 20 minutes. For the sham group, electrodes were placed in the same areas and a current of 0 mA was applied.
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
- None
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
- •Individuals between 18 and 65 years of age who had suffered from neck pain for at least 3 months
- •The rest pain score of 3-7 on the "Visual Analog Scale" (Javdaneh et al, 2021)
排除标准
- •Neurological or psychiatric disorders,
- •including acute/chronic depression, history of head trauma resulting in loss of consciousness
- •history of neurosurgical intervention
- •intracranial hypertension
- •implanted devices
- •history of migraine
- •history of chronic/severe headache
- •skin conditions (psoriasis, etc.), uncontrollable diseases (endocrinologic, cardiovascular, pulmonary, hematologic, hepatic, renal)
- •presence of systemic inflammatory disease or malignancy
结局指标
主要结局
Assessment of Muscular Endurance
时间窗: January 2023 to November 2023 (10 months)
To evaluate the cervical deep flexor muscular endurance test, participants took a hook-lying posture on a therapy table, maintaining a neutral neck position with the head and neck straightly aligned. With the assistance of a stabilizing device, a pressure sensor was situated under the neck with a stabilizer (Stabilizer Biofeedback). Participants were instructed to simulate a "yes" motion by gently nodding their heads, while avoiding movements that could activate the sternocleidomastoid muscle. The test involved a pressure range of 20-30 mmHg and required ten-second sustained pressure at each 2-mmHg increment without any breaks. The activation score was determined by measuring the pressure level at which the patient was able to perform and sustain 10 repetitions for a duration of 10 seconds, providing a measure of the strength of the deep cervical flexor muscles.
Assessment of Functional Limitations and Symptoms
时间窗: January 2023 to November 2023 (10 months)
The Profile Fitness Mapping neck questionnaire (ProFitMap-neck) was used to assess the functional limitations and symptoms associated with neck pain. The survey was graded on a scale of 0-100%, showing the highest score possible. This was the best result attainable through the assessment of the questionnaire. In addition to assessing neck pain, ProFitMap-neck considers stiffness, tension, and weakness that might occur in the neck and hands. This survey consists of two sub-indices. The first consists of 26 items that comprehensively assess the frequency and severity of symptoms, while the second comprises 18 items that assess functional limitations. Symptom frequency is rated on a scale of 1 to 6 points, where 1 indicates "not at all/rarely" and 6 corresponds to "often/always," as described in the Symptom Frequency Index. Symptom severity was rated on a scale of 7 to 12, with 7 being "not at all" and 12 being "almost unbearable/unbearable/very.
Assessment of Sleep Quality
时间窗: January 2023 to November 2023 (10 months)
The Pittsburgh Sleep Quality Index (PSQI) was used to assess sleep quality in individuals with chronic neck pain. The PSQI utilizes a standardized questionnaire to distinguish between good and poor sleepers. This comprises 19 self-rated questions and 5 questions answered by a bedmate/roommate. These 5 questions do not contribute to the scoring from a clinical perspective. The items of the PSQI use various response categories, including recording usual bedtime, usual wake time, number of hours actually slept, and number of minutes to fall asleep, as well as forced-choice Likert-type responses (0-3). The total scores of the components generate a single global score, ranging from 0 to 21.
Assessment of Cognitive Status
时间窗: January 2023 to November 2023 (10 months)
Individuals' cognitive status was assessed using the Montreal Cognitive Assessment (MoCA). The MoCA is a concise measurement tool developed by Ziad Nasreddine et al and used to detect mild cognitive impairment. MoCA application takes approximately 10 minutes. The highest total score that can be obtained from the test is 30. Accordingly, a score of 21 points or above is considered normal.
Assessment of Pain Severity
时间窗: January 2023 to November 2023 (10 months)
In order to evaluate the pain intensity of individuals with chronic neck pain, 10-cm Visual Analogue Scale (VAS) developed by Price et al. The 10-cm VAS is used to mark pain on a horizontal line where the first notch is 0, indicating no pain, and the last notch is 10, indicating the most severe pain. Participants marked their neck pain levels on the line, and the measurements were recorded in centimeters using a ruler.
次要结局
未报告次要终点
研究者
TDERE
Physiotherapist, Master Student (PT, MSc)
Hacettepe University