Corticospinal and Motor Behavior Responses After 6-week Transcranial Direct Current Stimulation and Neuromuscular Electrical Stimulation Combined With Motor Control Exercises in Patients With Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Corticospinal excitability measurement
研究概览
简要总结
This study aims to 1) determine the immediate effects of transcranial direct current stimulation (tDCS) on corticospinal excitability, lumbar multifidus muscle (LM) activation, as well as lumbar stability in patients with chronic low back pain (CLBP), 2) determine the immediate effects of neuromuscular electrical stimulation (NMES) on corticospinal excitability, LM activation, as well as lumbar stability in patients with CLBP, 3) compare the effectiveness of 6-week intervention program among tDCS priming with motor control exercise (MCE), NMES priming with MCE, and MCE alone in patients with CLBP, and 4) determine the associations among corticospinal excitability, LM activation, lumbar stability, movement patterns, and clinical outcomes in patients with CLBP.
详细描述
This proposed study will use a sample of convenience between the ages of 18 and 40. Subjects who has low back pain more than 3 months or a recurrent pattern of low back pain at least two episodes that interfered with activities of daily living and/or required treatment will be recruited by flyers posted in 2 university physical therapy clinics, as well as word of mouth from subjects and friends. Subjects without a history of low back pain in lifetime will be also recruited to establish normative data. Subjects who are interested in participation will undergo a screening process using inclusion-exclusion criteria checklist and receive brief information regarding the study. If they meet all inclusion criteria, the consent process will be performed.
All subjects will fill out the information sheet for demographic data. Subjects in CLBP will undergo standardized movement system impairment examination and transverse abdominis muscle thickness measurement, self-report questionnaires; pain, disability, quality of life, and fear of movement) and functional tests (5-time sit to stand test, 2-minute step test, functional reach test, prone trunk extension test and abdominal curl test). The project manager responsible for organizing the data collection and blindness will arrange the appointments with the subjects for 2 biomechanical data collection. For the subjects who refuse to participate in biomechanical lab testing, they will proceed to 6-week intervention.
In the first visit (pre-intervention visit#1), biomechanical data including motion and clinical data, lumbar stability, and cortical excitability will be collected. The body landmarks will be identified. These landmarks include 1) lumbar spinous process of T12-S2, 2) lumbar erector spinae (ES) and multifidus (LM) (3 cm lateral to L3 spinous process and 2 cm lateral to L3 spinous process, respectively), 3) bilateral lateral epicondyle of femur, and 4) bilateral lateral malleolus. Spinous process of L1, S2, bilateral lateral epicondyle of femur, and bilateral lateral malleolus will be used as locations for motion tracking sensors, while ES and LM location will be used to place surface electrode for cortical excitability measurement.
For motion and clinical observation data collection, subjects will be instructed to perform 1) sustained positions including usual sitting, corrected position in sitting, usual standing, corrected position in standing, as well as 2) functional movements including active forward bend, stand to sit, sit to stand, walking for 30 seconds, stair ascending, stair descending, and pick up a box from the floor. Then, the subjects will be asked to perform clinical movement tests including active forward bend (waiter's bow), standing with posterior tilt, single leg stance on left and right foot, single leg squat on left and right leg, supine with right and left straight leg raise tests, supine with right and left hip abduction with knee flexion tests, quadruped backward rock test, prone with right and left knee flexion tests, prone with right and left hip internal/external rotation tests, prone with right and left hip extension tests. 1-2 repetitions of practice trial will be provided to familiarize with the movement. Each subject performs 2 sets of 3 consecutive repetitions of each functional movement and clinical movement test in fixed order, while 2 assessors independently rate presence/absence of aberrant movement. Thirty-second rest will be provided between movement tests (rest period can be longer if necessary). Pain intensity, heart rate and rating of perceive exertion (RPE) will be monitored after each test. Motion sensors will be removed.
After that, subjects will undergo lumbar stability test. Two electromagnetic tracking sensors will be placed on T12 and S2 spinous processes, while one sensor will be attached to hand-held dynamometer. Subjects will be asked to position in prone on the treatment bed with both feet on the floor. A researcher will apply 10-kg compression force on L1 to L5 spinous processes for 2 seconds. This 10-kg compression force is derived from the pilot work in which the researchers plotted the graph between compression force in X-axis and posteroanterior displacement in Y-axis. The graph demonstrated plateau (no displacement even increasing in compression force) at approximately 10 kg. Then, subjects will be asked to lift both legs away from the floor presumably activating LM, while the researcher re-apply the same compression force on L1 to L5 again. Pain will be recorded when applying compression force on each spinal level. Sensor displacement will be collected to represent lumbar stability.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participant will be blinded using active vs sham intervention. Care provider is not involving in data collection and blinded to type of stimulation.
Outcomes assessor will be blinded to the group assignment.
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The inclusion criteria for individuals without a history of low back pain.
- •Between the ages of 18 and 40
- •No previous history of low back pain in lifetime.
- •The inclusion criteria for patients with CLBP individuals.
- •Between the ages of 18 and
- •Having low back pain over 3 months or a recurrent pattern of LBP at least two episodes that interfered with activities of daily living and/or required treatment. This information will be obtained by interview during subjective examination.
排除标准
- •History of seizure for either the subject or any family member
- •Implanted pacemaker
- •Clinical signs of systemic disease
- •Definitive neurologic signs including pain, weakness or numbness in the lower extremity
- •Previous spinal surgery
- •Diagnosed osteoporosis, severe spinal stenosis, and/or inflammatory joint disease
- •Any lower extremity condition that would potentially alter trunk movement
- •Vestibular dysfunction
- •Extreme psychosocial involvement
- •Body mass index (BMI) greater than 30 kg/m2
- •Active treatment of another medical illness that would preclude participation in any aspect of the study
- •Menstruation or pregnancy (for female subject)
- •Diagnosed herniated nucleus pulposus (HNP)
- •Contraindications for TMS and tDCS including open wound, infection, lesions, arteriosclerosis, history of haemophilia or demand-type pacemaker
- •Acute cerebral hemorrhage
- •Medications that can interfere the effect of tDCS including sodium channel blocker, calcium channel blocker, NMDA receptor antagonist
结局指标
主要结局
Corticospinal excitability measurement
时间窗: Change from baseline after 1 session and at 6 week after intervention.
Transcranial magnetic stimulation (TMS) will be used to measure corticospinal excitability including resting and active motor thresholds, motor evoke potentials, cortical silent period of LM, and topography (center of gravity coordinate; CoG and volume) of ES and LM, will be primary outcomes for objectives 1-4.
Kinematic measurement
时间窗: Change from baseline at 6 week after intervention.
Inertial measurement unit will be used to measure lumbopelvic motions during functional and clinical movement tests. These data can represent movement control. These data will be primary outcome for objectives 3 and 4.
Lumbar stability measurement
时间窗: Change from baseline after 1 session and at 6 week after intervention.
Electromagnetic tracking system will be used to measure spinal displacement during applying compression force to represent lumbar stability. This will be primary outcome measures for objective 1-4.
Clinical observation of aberrant movement
时间窗: Change from baseline at 6 week after intervention.
Clinician will observe the movements and rate as presence or absence of aberrant movement.
Muscle function measurement
时间窗: Change from baseline after 1 session and at 6 week after intervention.
Ultrasound imaging will be used to measure muscle function including TrA and LM thickness, cross-sectional area, and pennation angle will be primary outcome for objective 1-4.
次要结局
- Functional capacity(Change from baseline at 6 week after intervention.)
- Self-report questionnaires(Change from baseline at 6 week after intervention.)
研究者
Peemongkon Wattananon
Assistant Professor
Mahidol University
