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Effects of Exercises and Electrical Current Application Aiming to Strengthen Neck and Shoulder Blades Muscles on Symptoms of a Pinched Nerve in the Neck

E

European University of Lefke

Status

Enrolling

Conditions

Paresthesia
Endurance
Cervical Radicular Pain
Weakness, Muscle
Cervical Radiculopathy
Numbness
Neck Pain

Treatments

Procedure: Superimposition of electrical muscle stimulation on active movement
Procedure: Exercise Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT07375823
BAYEK057.12

Details and patient eligibility

About

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.

Full description

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 29 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Voluntary Exercise
Active Comparator group
Description:
Active therapeutic exercises prescription for neck and scapular region, including warm-up, strengthening and cool - down under supervision of a physiotherapist.
Treatment:
Procedure: Exercise Therapy
Electrically Stimulated Exercise
Experimental group
Description:
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.
Treatment:
Procedure: Superimposition of electrical muscle stimulation on active movement

Trial contacts and locations

1

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Central trial contact

Zhanna Abdrakhmanova, BSc in Health Sciences

Data sourced from clinicaltrials.gov

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