Stretching Versus Traction in Patients With Cervical Radiculopathy.

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare the effects of traction decompression and neck muscle stretching on the magnitude of Flexor Carpi Radialis H-Reflex(HR), Neck Disability Index (NDI), and Visual Analogue Scale (VAS) pain scores in patients with cervical radiculopathy.

Detailed Description
-----------------
Cervical traction has long been used to relieve compression of nerve roots caused by intervertebral discs. Yet, there is lack of knowledge that compares the effect of traction decompression with neck muscles stretching in patients with cervical radiculopathy

Official Title
-----------------
Which is Better to Decompress the Nerve Roots in Cervical Radiculopathy: Stretching or Traction From Foraminal Opening Position

Conditions
-----------------
Cervical Radiculopathy

Intervention / Treatment
-----------------
* Other: Stretching protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients should have C5-C6 and C6-C7 paramedian disc protrusion manifested by unilateral symptoms in C6-C7 roots dermatome and myotomes of the upper extremities. They were diagnosed as cervical disc protrusion (C5- C7) for at least three months. All patients should have a second grade of disc bulge (2-3mm) which was detected from T2 axial view of MRI. Exclusion Criteria: Patients will be excluded from the study if they have upper cervical spine disc pathology, cord compression and upper motor neuron symptoms, curvature abnormalities of the neck including reversed curve (kyphotic) and deformities, cervical rib syndrome, double crush syndrome, diabetic neuropathy, text neck , short neck (Churchill neck), Marked facet joint, neuro-central joint arthropathic pathology, osteoporosis.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomly assigned into two groups; A and B. Patients within Group (A) will receive stretching protocols to the cervical musculature at the side of symptoms. Group (B) will be treated with traction from 15-degree flexion, 30-degree lateral bending, and 15-degree rotation toward the painful side.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stretch<br>Patients within Stretch Group will receive stretching protocols to the cervical musculature at the side of symptoms. | Other: Stretching protocol<br>* Patients within Stretch Group will receive stretching protocols to the cervical musculature at the side of symptoms. Traction Group will be treated with traction from 15-degree flexion, 30-degree lateral bending, and 15-degree rotation toward the painful side.<br>* Other names: Traction using The Triton decompression system;|
| Active Comparator: Traction<br>Patients within Traction Group will be treated with traction from 15-degree flexion, 30-degree lateral bending, and 15-degree rotation toward the painful side. | Other: Stretching protocol<br>* Patients within Stretch Group will receive stretching protocols to the cervical musculature at the side of symptoms. Traction Group will be treated with traction from 15-degree flexion, 30-degree lateral bending, and 15-degree rotation toward the painful side.<br>* Other names: Traction using The Triton decompression system;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Flexor Carpi radialis H-reflex | The peak-to-peak amplitudes of the four FCR-HR traces will be measured and averaged for each patient | change from Baseline after 6-week of treament | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Visual Analogue Scale Pain Scores(VAS) | A 10-cm VAS was used for assessing pain intensity. It is a line whose ends are labeled as the extremes of pain; no pain and very extreme pain. The line is marked at intervals 1 cm each without any label. Patients will be simply asked to indicate which point along the line that best represents the intensity of perceived pain. The distance from the no pain end to the mark made by the patient will be measured as the patient's pain intensity score. | Change from Baseline after 6-week of treament | 
| The Neck Disability Index (NDI) | The NDI will be measured on a 6-point scale from 0 (no disability) to 5 (full disability). The numeric response for each item will be summed for a score varying from 0 to 50. The NDI consists of 10 sections, each section the total possible score is 5, if the first statement is marked; the section score = 0, if the last statement is marked it = 5. The patients will choose the best choice that reflect his current state. If all ten sections are completed the score is calculated by dividing the obtained score on the total number of scores e.g. if the score recorded by the patients was (40) so the NDI=(40/50)x100=80% | Change from Baseline after 6-week of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stretching, Traction Decompression