An interventional study of Exercise Therapy and Superimposition of electrical muscle stimulation on active movement in Cervical Radiculopathy, Cervical Radicular Pain and Neck Pain, sponsored by European University of Lefke. Completed at 1 site in Cyprus. Open to participants aged 18 Years to 29 Years. Per ClinicalTrials.gov, last updated 2026-03-24.
Sponsored by European University of Lefke · Not applicable, Interventional, and Treatment
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.
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.
Nevertheless, results of more recent studies, are favoring application of EMS on various muscle groups, for example it was stated that EMS has significant effect on muscle strength of quadriceps and trunk extensors, similar results were also observed in the study assessing effects of EMS on upper extremity strength. Moreover, it was shown that neuromuscular electrical stimulation (NMES) induced a decrease of cortical activation during execution of hand movements, which indicates that application of NMES can increase the efficiency of the cerebral cortex during execution of motor tasks.
One should also consider that in the recent systematic review solitary ET directed on strengthening deep cervical flexors, scapulo - thoracic and upper extremity muscles had beneficial effect on pain and function at immediate post treatment and up to long-term follow-up. Moreover, strong evidence was found for effectiveness of deep cervical flexors (DCF) training on neuromuscular coordination of the neck, because it reduces the overactivation of the superficial muscles and improves the activation pattern of the cervical muscles.
It is also worth mentioning that, compared with the healthy adults, the individuals with CR have significantly smaller anterior displacements of the centers of mass and pressure, reduced muscle activity of the upper trapezius, sternocleidomastoid and splenius capitis muscles in response to all postural perturbations. Those findings are indicative of altered neural control of the neck musculature, leaving the cervical spine vulnerable to reactive forces.
Thus, physical therapy options for conservative management of CR should mainly focus on improving muscle function and neuromuscular control of the neck.
Given the promising results of EMS and ET, it is worth to investigate both in terms of neck muscle function. Thus, this research will try to do that.
Looking at the existing literature, training based on electrical muscle stimulation and voluntary muscle contraction has positive effects on muscle strength of various muscle groups, when applied in superimposition due to facilitation of additional muscle fibers recruitment.
However, superimposition of electrical stimulation on exercise was not assessed in the context of CR patients, who present with incomplete central activation levels and could favor from this kind of treatment, in terms of improving motor control. Additionally, restoring muscle balance in cervico - scapular region, adds to the proper neutral alignment of the cervical vertebrae, leading to increased intervertebral foraminal area, decreased nerve root compression and relieve of cervical radiculopathy symptoms.
Thus, the proposed study is aimed to investigate the effects of exercise therapy with electrical muscle stimulation and just exercise on cervical muscle function. Secondly, compare the effects of both therapy options. Lastly, see if improvement of neck muscle function would have and impact on cervical radiculopathy symptoms, in terms of pain and motor deficits.
483 studies on the registry are indexed under Radiculopathy; 145 are open to participants now.
This study's enrollment of 50 is below the median of 60 across 373 interventional studies indexed under Radiculopathy.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active therapeutic exercises prescription for neck and scapular region, including warm-up, strengthening and cool - down under supervision of a physiotherapist.
Procedure: Exercise Therapy
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.
Procedure: Superimposition of electrical muscle stimulation on active movement
Active therapeutic exercises prescription in face - to - face therapy sessions under supervision, for the duration of approximately 60 minutes per session. Therapy session will start with a warm - up including segmental stability exercise , i.e. deep cervical flexors training to improve neuromuscular coordination of the neck: Participant will do chin - tucks (cervical retraction and axial extension) for 2 sets of 5 seconds hold for 12 repetions, with between set rest interval of 2 minutes, in sitting. Next, participant will perform global stability exercises emphasizing flexor and extensor group musculature, with a gym ball, as a part of strengthening protocol. Lastly, as a cool -down, participant performs: pectoralis stretch, scalene stretch, suboccipitals stretch. Each position is held for 15 seconds and repeated 4 times for each muscle group bilaterally.
EMS will be applied over scapular region, bilaterally. Electophysiological motor points of upper trapezius will be identified through surface mapping with a pen electrode to minimize limited spatial recruitment of motor units, that occurs due to poor electrodes placement. Reference electrode is placed at the antagonist muscle, i.e. insertion of lower trapezius over the medial end of spine of scapula. Self - adhesive, disposable electrodes (4pcs) will be allocated for each participant at the first session. Movements of the participants will be synchronized with the EMS impulses, i.e. motion intiation - ramp up, hold - on time, rest - off time. Since present systematic reviews contain low quality evidence and EMS parameters are highly heteregenous, choice of the parameters will be done activating slow - twitch endurance muscle fibers.
Deep Neck Flexors Endurance Test
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.
Time frame: From pre - treatment (at the enrollment stage) to post - treatment assessment after 6 weeks (12th session).
Cervical Progressive Iso - Inertial Lifting Evaluation
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.
Time frame: From pre - treatment (at the enrollment) to post - treatment assessment after 6 weeks (12th session).
Muscle Strength Assessment
Muscle strength testing of the Biceps Brachii and Deltoid had highest sensitivity, while Biceps Brachii and Triceps Brachii had highest specificity, with overall sensitivity being 61% compared to imaging and electromyographic studies in the diagnosis of Cervical Radiculopathy. Thus, muscle strength of biceps brachii, triceps brachii and deltoids will be used as an outcome measure in this study and assessed according to Manual Muscle Test grades 0 to 5. Muscle strength has been classified into 6 grades, from 0 being no evidence of muscle contraction, 1- palpatable muscle contraction and no range of motion, 2 - active movement throughout range of motion without gravity, 3 - active movement throughout range of motion against gravity and no other resistance, 4 - active range of motion against gravity and slight resistance, 5 - ability to maintain test position against gravity and maximal resistance.
Time frame: From pre - treatment (at the enrollment) to post - treatment assessment at 6 weeks (after 12th session).
Pain (Numeric Pain Rating Scale)
The intensity of pain can be assessed by Numeric Rating Scale (NRS) in cases of Cervical Radiculopathy. The Numerical Rating Scale uses whole numbers from 0 to 10 along a line or a bar, with 0 indicating no pain and 10 being the most excruciating pain one has ever felt. 4 or 5 points (average pain intensity) on the 10 point scale are usually considered as an indication for physical therapy.
Time frame: From pre - treatment (at enrollment stage) to post - treatment assessment at 6 weeks (after 12th session).
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European University of Lefke