- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07429981
Nerve Gliding Exercises in Cervical Radiculopathy
Investigation of the Effectiveness of Nerve Gliding Exercises in Individuals With Cervical Radiculopathy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The cervical spine is not only the most mobile region of the spine, but also acts as a functional bridge between the head and the torso, consisting of a total of seven vertebrae. The vertebrae in this region are relatively small in size and have a high capacity for movement due to the need for a wide range of joint motion; these characteristics allow for free movement of the head and enable optimal head-neck positioning in response to environmental stimuli.
Mechanical compression, irritation or inflammation of the cervical nerve roots results in a clinical picture of cervical radiculopathy (broadly defined as cervical neuropathy). This condition presents with symptoms such as pain radiating from the neck to the upper extremities, paraesthesia, muscle weakness and sensory loss. Spondylotic changes in the mobile cervical segments can lead to a decrease in intervertebral disc height, disc protrusion, and degenerative changes in the facet joint capsule.
In cervical radiculopathy, patients may only complain of upper extremity pain; however, they report significant difficulties in functions such as hand-eye coordination, gross and fine grip strength, dressing, and heavy lifting. Indeed, in radiculopathy, in addition to pain and sensory changes, decreased grip strength and reduced upper extremity function are frequently observed findings.
The specific clinical presentations at the root level vary. In C5 root involvement, pain radiates from the end of the cervical level over the shoulder to the upper lateral aspect of the arm; involvement of the deltoid and biceps muscles may cause painful limitation in shoulder abduction and elbow flexion. Degenerative disc disease most commonly affects the C5-6 and C6-7 levels. In C6 root compression, pain starts in the lower part of the neck and extends to the biceps, lateral forearm, and dorsal hand/fingers; it is often accompanied by pain in the proximal arm and sensory deficit in the hand. The most common cause of C7 root radiculopathy is disc herniation; pain in the back of the shoulder and dorsolateral arm with decreased triceps reflex is typical; triceps weakness during overhead activities may be a prominent complaint. The flexor carpi radialis, pronator teres, extensor digitorum communis, and latissimus dorsi may also be affected. The C8 root innervates sensation in the ulnar side of the forearm and hand; compression may cause pain and numbness similar to ulnar nerve lesions. With involvement of the flexor digitorum profundus/superficialis and intrinsic hand muscles, finger flexion and abduction become difficult; weakness of the first dorsal interosseous muscle impairs fine hand skills (e.g., turning a key, holding small objects) and reduces grip strength.
The primary goals of rehabilitation are to reduce pain, preserve nerve function, increase range of motion, and improve quality of life. Among conservative approaches, neural gliding/sliding exercises have gained increasing prominence in recent years. These exercises are targeted manual/exercise-based applications that aim to increase the relative movement of compressed nerve tissue in relation to surrounding tissues; they are reported to improve transmission by reducing intraneural pressure, increase intraneural circulation, and improve the mobility of the connective tissue surrounding the nerve. These mechanisms target pain reduction, increased functional capacity, and improved nerve mobility.
The current literature reports positive effects of nerve gliding exercises on pain, function, and cervical range of motion in cervical radiculopathy. However, most studies have focused on a single peripheral nerve (mostly the median nerve) and applied nerve mobilisation using "one-size-fits-all" protocols independent of the affected root level. This approach carries the risk of overlooking the clinically distinct patterns of radiculopathy that vary according to the root level.
Therefore, our planned study aims to compare the effectiveness of targeted nerve gliding exercises specific to the peripheral nerves (median, ulnar, radial) in cases affected at the C5-C6, C6-C7, and C7-T1 levels. Thus, the effect of nerve mobilisation will be evaluated based on specific nerve-root relationships; determining which nerve mobilisation is more effective at which root level will provide a unique contribution to individualised clinical decision-making processes in the treatment of cervical radiculopathy.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eda AKBAŞ, PhD
- Phone Number: +903722613341
- Email: akbas.pt@gmail.com
Study Contact Backup
- Name: Öznur GÜNEY, MSc
- Phone Number: +903722613342
- Email: oznur1123@gmail.com
Study Locations
-
-
-
Zonguldak, Turkey (Türkiye)
- Zonguldak Atatürk State Hospital
-
Contact:
- Merve DEMİRCİ, MD
- Phone Number: +903722521900
- Email: mervedmrc__@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Have been diagnosed with cervical radiculopathy by a specialist physician
- Have disc herniation at the C5-C6, C6-C7 or C7-T1 level according to imaging (magnetic resonance imaging, MRI) findings (in the bulging or protrusion stage)
- Have unilateral nerve root involvement
Exclusion Criteria:
- Predominance of primary peripheral entrapment neuropathy (carpal/cubital/radial tunnel, etc.)
- Multiple nerve root involvement
- Progressive neurological deficit
- History of trauma or surgery to the cervical and upper extremity region
- Systemic disease contraindicating exercise
- Pregnancy
- Manual therapy, injection, or regular physiotherapy applied to the cervical region within the last 3 months
- Cognitive/psychiatric condition preventing compliance with the assessment protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group
Conventional rehabilitation program (isometric neck strengthening exercises, neck stretching exercises) for cervical radiculopathy.
|
This group will have convantional rehabilitation program.
|
|
Experimental: Intervention Group
Conventional rehabilitation program (isometric neck strengthening exercises, neck stretching exercises) for cervical radiculopathy and neuromobilization exercises.
|
This group will have convantional rehabilitation program and neuromobilization exercises.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS)
Time Frame: 3 weeks
|
The Visual Analog Scale (VAS) will be used to evaluate pain for rest, activity and night periods.
The data will be recorded in centimeters.
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cervical range of motion (CROM)
Time Frame: 3 weeks
|
For CROM, a CROM goniometer will be used to measure cervical flexion, extension, right and left rotation, and right and left lateral flexion movements.
The individual will be asked to move to the maximum extent in one direction, and the final position reached will be recorded in degrees.
|
3 weeks
|
|
Nerve cross-sectional area (CSA)
Time Frame: 3 weeks
|
Will be measured using ultrasound imaging.
The results will be recorded in mm².
|
3 weeks
|
|
Cervical joint position sense
Time Frame: 3 weeks
|
The cervical joint position sense assessment will be performed using the CROM goniometer, targeting 30 and 50 degrees in the directions of flexion, extension, right and left rotation, and right and left lateral flexion.
The deviation amount will be calculated by taking the difference between the targeted angle and the position achieved by the individual and will be recorded in degrees.
|
3 weeks
|
|
Nerve excursion measurement
Time Frame: 3 weeks.
|
It will be measured using ultrasound imaging.
The results will be recorded in mm.
|
3 weeks.
|
|
Deep cervical flexor muscle endurance
Time Frame: 3 weeks
|
The endurance of the deep cervical flexor muscles will be assessed using the craniocervical flexion test with the Stabilizer Pressure Biofeedback device.
Using the device's feedback, the patient will be asked to perform craniocervical flexion movements starting at 20 mmHg and increasing progressively in 2 mmHg increments up to 30 mmHg.
The pressure level at which the individual can successfully hold the position for 10 seconds will be recorded as the activation point, while the number of repetitions at the pressure level at which the patient can hold the position for 10 seconds will be recorded as the performance index.
|
3 weeks
|
|
Gross grip strength
Time Frame: 3 weeks
|
For gross grip strength measurement, a hydraulic hand dynamometer (Baseline®, USA) will be used.
The measurement will be conducted in the standard position specified by the American Society of Hand Therapists.
In this position, the individual will sit on a chair with back support, with the elbow at 90 degrees of flexion and the wrist in a neutral position.
The person will be asked to squeeze the dynamometer with maximum force.
The measurement will be repeated three times, and the average will be recorded in kg/f.
|
3 weeks
|
|
Pinch grip strength
Time Frame: 3 weeks
|
For pinch grip strength measurement, a mechanical pinch meter (Baseline®, USA) will be used.
Lateral (key) pinch, two-point (bipod, tip) pinch, and three point (tripod, palmar) pinch measurements will be performed separately.
The measurements will be repeated three times for each side, and the averages will be recorded in kg/f.
|
3 weeks
|
|
Neck Disability Index
Time Frame: 3 weeks
|
The Neck Disability Index (NDI) is designed to measure neck-specific disability, with the aim of assessing function and quality of life.
The questionnaire consists of 10 items related to pain and daily living activities, including personal care, lifting, reading, headaches, concentration, work status, driving, sleep, and leisure.
Each item is scored out of five (no disability response is given 0 points) and a total score out of 50 is given for the questionnaire.
Higher scores represent greater disability levels.
The result will be reported out of 100 by doubling the total score.
|
3 weeks
|
Collaborators and Investigators
Investigators
- Study Chair: Öznur GÜNEY, Zonguldak Bulent Ecevit University
- Study Chair: Eda AKBAŞ, Zonguldak Bulent Ecevit University
- Principal Investigator: Merve DEMİRCİ, MD, Zonguldak Atatürk State Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BEUN-AKBAS-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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