- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07366983
Effect of Cervical Traction With Neural Mobilization on Nerve Root Functions in Cervical Radiculopathy Patients
January 17, 2026 updated by: Mohamed Nagy Elshafey, Cairo University
Effect of Cervical Traction From Different Angles With Neural Mobilization on Nerve Root Functions in Cervical Radiculopathy Patients
This study will be conducted to examine
- The efficacy of mechanical traction from decompression angles combined with neural mobilization on the H reflex of flexor carpi radialis.
- The efficacy of mechanical traction from decompression angles combined with neural mobilization on ultrasonography changes.
- The efficacy of mechanical traction from decompression angles with neural mobilization has a Numeric Pain Rating Scale.
- The efficacy of mechanical traction from decompression angles combined with neural mobilization on Neck Disability Index.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Detailed Description
Cervical radiculopathy is a condition characterized by pain, sensory and motor impairments, and slowed reflexes caused by the compression of cervical nerve roots, often stemming from cervical disc herniation.
The etiology includes mechanical compression and chemical irritation, commonly due to foraminal stenosis.
Cervical radiculopathy pain is a combination of nociceptive and neuropathic components, with various conservative treatments available, including immobilization and physical therapy, although evidence for their efficacy is limited.
Neural mobilization especially when combined with cervical traction, shows promise in alleviating nerve-related pain and enhancing treatment adaptability.
Techniques involving specific joint movements can enhance foraminal dimensions, thereby affecting nerve tension and circulation.
This study uniquely examines the effects of head positions on foraminal opening and clinical outcomes, including H reflex and ultrasonography changes.
Study Type
Interventional
Enrollment (Estimated)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mohamed Nagy Abd ELfatah ELshafey, Assistant lecturer
- Phone Number: 01155273157
- Email: mnagy@horus.edu.eg
Study Locations
-
-
-
Damietta, Egypt
- out-patient clinic, faculty of physical therapy, Horus university
-
Contact:
- Mohamed Nagy Abd ELfatah ELshafey, Assistant lecturer
- Phone Number: 01155273157
- Email: mnagy@horus.edu.eg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- History of steroid injection.
- Complete loss of sensation along the involved nerve root.
- bilateral radiating upper extremity
- Diabetic polyneuropathy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: multimodal physical therapy program and traction with neural mobilization (30 degree) head flexion
Patients will receive multimodal physical therapy program, and 20 min mechanical traction of cervical from 30-degree head flexion combined with neural mobilization, 3 sessions per week for 6 weeks
|
Triton 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.
All 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.
In 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.
The 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.
The 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.
|
|
Active Comparator: multimodal physical therapy program and traction with neural mobilization (30 degree) side bending
Patients will receive multimodal physical therapy program, and 20 min mechanical traction of cervical while head will in 30° lateral bending to the pain-free side combined with neural mobilization, 3 sessions per week for 6 weeks.
|
All 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.
In 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.
The 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.
The 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.
Triton 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.
|
|
Active Comparator: multimodal physical therapy program and traction with neural mobilization (foramen opening position)
Patients will receive multimodal physical therapy program, and 20 min mechanical traction of cervical while the head will be in 30° flexion, 15° rotation toward the painful side, and 30° lateral bending toward the pain-free side combined with neural mobilization, 3 sessions per week for 6 weeks.
|
All 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.
In 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.
The 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.
The 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.
Triton 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
assessment of pain intensity
Time Frame: at baseline and after 6 weeks
|
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.
|
at baseline and after 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of neck functional activities
Time Frame: at baseline and after 6 weeks
|
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.
|
at baseline and after 6 weeks
|
|
assessment of H reflex for the median nerve
Time Frame: at baseline and after 6 weeks
|
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.
|
at baseline and after 6 weeks
|
|
assessment of nerve root function
Time Frame: at baseline and after 6 weeks
|
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.
|
at baseline and after 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 1, 2026
Primary Completion (Estimated)
May 1, 2026
Study Completion (Estimated)
June 1, 2026
Study Registration Dates
First Submitted
January 17, 2026
First Submitted That Met QC Criteria
January 17, 2026
First Posted (Actual)
January 26, 2026
Study Record Updates
Last Update Posted (Actual)
January 26, 2026
Last Update Submitted That Met QC Criteria
January 17, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Nagy-Phd
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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