Effect of Cervical Traction With Neural Mobilization on Nerve Root Functions in Cervical Radiculopathy Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-45
SponsorCairo University
About this trial
This study will be conducted to examine
1. The efficacy of mechanical traction from decompression angles combined with neural mobilization on the H reflex of flexor carpi radialis. 2. The efficacy of mechanical traction from decompression angles combined with neural mobilization on ultrasonography changes. 3. The efficacy of mechanical traction from decompression angles with neural mobilization has a Numeric Pain Rating Scale. 4. The efficacy of mechanical traction from decompression angles combined with neural mobilization on Neck Disability Index.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patient's age will be ranged from 30 to 45 years old for both genders.
The patient's with unilateral C5-6 and C6-7 (posterior lateral disc protrusion) confirmed by T 2, axial view of magnetic resonance imaging
The patient's symptoms more than 3 months and positive provocative test for cervical radiculopathy (Spurling's test, shoulder abduction test, neck distraction test, and upper limb tension test 1 (Median nerve).
Sensory, reflex, and/ or motor changes in the upper limb
Disqualifiers
History of surgical procedures for pathologies giving rise to neck pain or carpal tunnel syndrome
Clinical signs or symptoms of medical "red flags" (infection, cancer, and cardiac involvement).
Patients with neck pain for signs and symptoms of serious pathology, including suspected arterial insufficiency, upper cervical ligamentous insufficiency, unexplained cranial nerve dysfunction, and fracture.
Systemic diseases such as autoimmune and metabolic diseases.
Trial design
Design model
Parallel
Treatments tested in this trial
traction (30 degree) head flexion
DeviceTriton decompression system is designed to apply traction to the cervical vertebrae in patients grouped as A, B, and C. The system includes a Triton decompression traction unit and a QuikWrapTM belting system, with traction starting from specified angles (30-degree head flexion) and an initial force of 10% of the patient's body weight, increasing by 1-2 kg as needed. Each session consists of 20 minutes of intermittent traction, allowing stress management through a bursar switch. Concurrently, neural mobilization involves shoulder depression and arm abduction, leading into either sliding or gliding of the median nerve, performed over specific sets and repetitions with designated rest periods.
Deep neck flexor strengthening exercise
Other interventionAll patients are instructed to perform a home program involving chin-in exercises from a supine position, focusing on upper cervical spine extension and flexion. Participants will move their heads backwards and then return to the starting position, ensuring slow, controlled movements while palpating their necks to relax superficial neck muscles. The exercises will be done twice a week for six weeks, with each hold lasting 10 seconds, 15-second breaks between holds, and 10-15 repetitions in total.
Sub occipital Release
Other interventionIn a supine position with the head on a pillow, the patient is treated by a therapist seated at the head of the table. The therapist uses both hands (digits 2 to 5) to contact the base of the occiput, gently lifting the head anteriorly while allowing the dorsum of the hands to rest on the pillow. This technique involves cranial pulling as the patient's sub occipital muscles relax, with distraction maintained for up to 5 minutes as tissue slack becomes available. Once relaxation is achieved, the therapist positions the shoulder against the patient's forehead to enhance sub occipital distraction.
Hold/Relax Stretch
Other interventionThe therapy procedure involves positioning the patient supine and performing specific movements to address shoulder and neck tension. The therapist supports the occiput and rib area while guiding the neck into forward bending and lateral flexion, combined with right or left rotation, depending on the sequence. The patient is instructed to perform isometric contractions by elevating the shoulder against resistance for 10 seconds, followed by relaxation, with additional stretches held for 10 seconds. This process is repeated three to four times and includes a home stretching program, holding stretches for 30 to 60 seconds two to three times daily.
Prone Cervical Unilateral Poster anterior Mobilization
Other interventionThe patient is positioned prone with a pillow under their chest, and their head and neck are in a neutral position, while the therapist stands at the head. The therapist places both thumbs on the spinous process of the targeted vertebra and applies a gentle posterior to anterior force to assess pain, mobility, and end feel, gradually increasing the force for four to five repetitions.
traction (foramen opening)
DeviceTriton decompression system is designed to apply traction to the cervical vertebrae in patients grouped as A, B, and C. The system includes a Triton decompression traction unit and a QuikWrapTM belting system, with traction starting from specified angles (flexion, lateral bending and rotation according to pain) and an initial force of 10% of the patient's body weight, increasing by 1-2 kg as needed. Each session consists of 20 minutes of intermittent traction, allowing stress management through a bursar switch. Concurrently, neural mobilization involves shoulder depression and arm abduction, leading into either sliding or gliding of the median nerve, performed over specific sets and repetitions with designated rest periods.
traction (30 degree) side bending)
DeviceTriton decompression system is designed to apply traction to the cervical vertebrae in patients grouped as A, B, and C. The system includes a Triton decompression traction unit and a QuikWrapTM belting system, with traction starting from specified angles (30 degree) side bending and an initial force of 10% of the patient's body weight, increasing by 1-2 kg as needed. Each session consists of 20 minutes of intermittent traction, allowing stress management through a bursar switch. Concurrently, neural mobilization involves shoulder depression and arm abduction, leading into either sliding or gliding of the median nerve, performed over specific sets and repetitions with designated rest periods.
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: multimodal physical therapy program and traction with neural mobilization (30 degree) head flexionExperimental treatment 5 interventions
Group B: multimodal physical therapy program and traction with neural mobilization (30 degree) side bendingActive comparator 5 interventions
Group C: multimodal physical therapy program and traction with neural mobilization (foramen opening position)Active comparator 5 interventions
Trial outcomes
Primary outcomes
1
assessment of pain intensity
Pain intensity was evaluated using the Numeric Pain Rating Scale (NPRS), a validated self-reported measure. Participants rated their pain on an 11-point scale from 0 (no pain) to 10 (worst pain imaginable), after receiving an explanation of the scale. NPRS scores were documented at baseline and scheduled follow-ups to track pain intensity changes during the intervention, with higher scores reflecting greater pain severity.
Time frame
at baseline and after 6 weeksSecondary outcomes
1
Assessment of neck functional activities
The Neck Disability Index is a widely recognized tool for assessing the impact of neck pain on functional activities and measuring outcomes in clinical settings. It includes 10 questions addressing pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. The Arabic version of the Neck Disability Index is a valid instrument for evaluating disabilities in neck pain patients, demonstrating high reliability with an interclass correlation of 0.96.
Time frame
at baseline and after 6 weeks2
assessment of H reflex for the median nerve
Flexor carpi radialis H-reflex is measured using an electromyogram in a semi-supine position with a supinated forearm. Hair may be removed from the anterior forearm to reduce signal resistance. The motor point of the Flexor carpi radialis is identified by applying low-threshold stimuli, aiming for the maximum response at the lowest threshold. A recording electrode is positioned at this motor point, with a reference electrode on the lateral forearm and a ground electrode proximally. To elicit the H-reflex, a surface-stimulating electrode is applied along the median nerve in the antecubital fossa.
Time frame
at baseline and after 6 weeks3
assessment of nerve root function
High-resolution ultrasonography will utilize a 12- to 18-MHz linear probe to assess cervical nerve roots (NR) in seated patients with lateral neck flexion. Contralateral unaffected nerve root will serve as controls. To minimize anisotropy, the transducer will be positioned at right angles and rotated to identify the minimal cross-sectional area. C7 vertebra identification will precede imaging of the anterior and posterior tubercles of C6. The transducer will be moved to capture axial views of C5, C6, and C7 nerve roots, maintaining proximity to the transverse processes at the nerve root exit points.
Time frame
at baseline and after 6 weeksSponsors and contacts
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Source ClinicalTrials.gov
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