Effects of Electrical Muscle Stimulation Applied Concurrently With Active Movement and Exercise Therapy in Cervical Radiculopathy: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Deep Neck Flexors Endurance Test
研究概览
简要总结
Cervical Radiculopathy (CR) is an objective loss of sensory and/or motor function as a result of compression or irritation of the cervical spinal nerve root.
The individuals with CR present with findings indicating an altered neural control of the neck musculature, leaving the cervical spine vulnerable to reactive forces.
Thus, physical therapy options should mainly focus on improving muscle function of the neck.
Given the promising results of electrical muscle stimulation and exercise therapy in recent literature the proposed study is aimed to investigate the effects of exercise therapy with electrical muscle on cervical muscle function and see, if muscle control has any impact on CR findings.
A superiority, randomized trial, with 2 intervention groups and allocation ratio of 1:1. 50 students, at the age from 18 to 29, from healthcare - related departments of European University of Lefke, who are diagnosed with CR will be recruited in the study.
To assess neck muscle function - Deep Neck Flexors Endurance time (s) and Cervical Progressive Iso - inertial Lifting scores (kg) will be used. Pain (Numeric Rating Scale 0 -10) and Muscle strength (grades 0 -5) will be used to measure the impact on CR findings.
All of the therapeutic exercises prescription parameters for warm-up (deep cervical flexors training), strengthening (cervical and scapulo-thoracic resistance training) and cool - down (flexibility training), will be the same for both groups: 60 minutes per session, 2 days in a week, for 6 weeks. In total each participant will recieve 12 sessions.
For the intervention details, while 'Intervention Group 1' will recieve only active exercises under supervision of the physiotherapist, in 'Intervention Group 2' as a part of the strengthening protocol, EMS will be applied over scapular region, bilaterally.
详细描述
Cervical Radiculopathy (CR) is an objective loss of sensory and/or motor function as a result of conduction block in axons of a spinal nerve or its roots due to compression or irritation of the cervical spinal nerve root . Etiology is attributed to cervical foraminal compression in 70-75 % of cases due to anterior and posterior degenerative changes of the zygapophyseal joints, cervical spondylosis and reduction in disc height. The most common clinical manifestations of CR include sensory impairments (e.g. paresthesia), motor abnormalities (e.g. muscle weakness) and neck pain radiating to the arm.
It is a common diagnosis, incidence of which ranged between 0.832 - 1.79 per 1,000 person, and prevalence values ranged from 1.21 - 5.8 per 1,000 according to the latest epidemiological studies.
The incidence of neck pain was found to be high in college students: 48%-78%. What is more, the annual growth rate of cervical spondylosis in college students was twice that of the 50-year-old participants. A high incidence of neck pain among college students was associated with a heavy academic workload and the pressure of examinations, which may lead to the deformation of the neck and shoulders, as well as soft tissue damage.
In the meta-analysis of the college grade differences on neck pain in 2287 college students, it was shown that a higher probability and frequency of neck pain occurred at senior grade level. As can be seen from the review of existing literature, based on the incidence of neck pain, the potential of developing cervical radiculopathy is increasing at a younger age than was previously believed, with the peak age being 50 to 54 years. If left untreated, CR could lead to future disability and persistent functional impairments due to neural inflammation and edema, hypoxia and ischemia of structures.
However, despite the severity of the condition and the rapid incidence growth rate, there is still a lack of evidence in the area of conservative treatment, i.e. physiotherapy options. In previous studies, Electrical Muscle Stimulation (EMS) had no significant impact on pain relief, disability and patient satisfaction when used as an adjunct to cervical mobilization and manipulation, at post treatment, short-term and intermediate-term follow-up. Moreover, exercise treatment (ET) also consists of various interventions and is typically combined with drugs and other treatments, which make it difficult to determine the effects of a single intervention.
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 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Student must be enrolled in the last 2 years of Bachelor degree or in Master's degree in one of the healthcare - related programs at the European University of Lefke;
- •Age 18 - 29 years old;
- •Neck pain of minimum 4 or more on numerical rating scale (0 - 10);
- •Duration of symptoms 3 < months < 6, i.e. subacute symptoms with chronic/stable presentation;
- •Has 1 or more of the following symptoms: paresthesia of 1 or both upper extremities at the level below elbow; pain radiating from neck to shoulder/arm/below elbow; feeling of weakness in 1 or both of the upper extremities, stiffness and/or tenderness and/or hyperalgesia in the cervical and/or upper thoracic area;
- •Obtained "Cervical Radiculopathy" diagnosis from a physician, according to neurological examination findings: Positive cervical radiculopathy specific provocative tests (Spurling's Maneuver, Upper Limb Tension Test; Reduced Deep Tendon Reflexes of brachioradialis, biceps and triceps.
排除标准
- •Any recent head/neck or shoulder trauma in the last 3 months;
- •Received physiotherapy for neck - related complaints in the last 3 months;
- •Received or currently receiving any kind of pharmacological intervention (muscle relaxants, NSAIDs, corticosteroids injections) in the last 3 months;
- •Presents with symptoms favoring shoulder pathology: pain localized at the shoulder that worsens at night, positive Drop Arm Test, pain referral patterns are localized in the upper arm above elbow;
- •Any recent surgeries to the neck, upper extremities within the last 6 months;
- •Any diagnosed neurologic or musculoskeletal conditions that could mimic cervical radiculopathy, i.e. peripheral neuropathies of different origin, thoracic outlet syndrome medial/lateral epicondylitis, myofascial pain syndrome, etc.;
- •Any cardiovascular (recent DVT, congestive heart failure), metabolic (diabetic polyneuropathy), neurologic (impaired consciousness, epilepsy), malignant conditions in which application of electrotherapy or exercises imposes risk on the patient;
- •Presence of pregnancy;
- •Active implants, e.g. cardiac pacemaker;
- •Any skin lesions in the cervical and/or scapular region, i.e. infections, open - wounds;
- •Refuses to participate in the study.
研究组 & 干预措施
Voluntary Exercise
Active therapeutic exercises prescription for neck and scapular region, including warm-up, strengthening and cool - down under supervision of a physiotherapist.
干预措施: Exercise Therapy (Procedure)
Electrically Stimulated Exercise
All of the therapeutic exercises prescription parameters for warm-up, strengthening and cool - down, including patient positioning, type of exercise, duration, frequency and intensity will be the same as in 'Voluntary Exercise'.
For the intervention details, while 'Voluntary Exercise' will recieve only active exercises under supervision of the physiotherapist, in 'Electrically Stimulated Exercise' as a part of the strengthening protocol, electrical muscle stimulation unit will be applied over scapular region, bilaterally.
干预措施: Superimposition of electrical muscle stimulation on active movement (Procedure)
结局指标
主要结局
Deep Neck Flexors Endurance Test
时间窗: From pre - treatment (at the enrollment stage) to post - treatment assessment after 6 weeks (12th session).
To assess motor control of the neck, deep neck flexors endurance test will be used as a measure of neck muscle function. The reliability indexes suggest that the Deep Neck Flexors Endurance Test (DNFET )is an appropriate measure for group comparisons.
Cervical Progressive Iso - Inertial Lifting Evaluation
时间窗: From pre - treatment (at the enrollment) to post - treatment assessment after 6 weeks (12th session).
Cervical Progressive Iso - Inertial Lifting Evaluation is functional restoration measure in spinal disorders. The endurance test of the short neck flexors and the cervical PILE test can be regarded as appropriate instruments for measuring different aspects of neck muscle function in patients with non-specific neck pain. Moreover, the cervical PILE test - showed high inter-rater reliability and between-days repeatability out of 8 physical performance tests.
次要结局
- Muscle Strength Assessment(From pre - treatment (at the enrollment) to post - treatment assessment at 6 weeks (after 12th session).)
- Pain (Numeric Pain Rating Scale)(From pre - treatment (at enrollment stage) to post - treatment assessment at 6 weeks (after 12th session).)
研究者
Zhanna Abdrakhmanova
Physiotherapist
European University of Lefke