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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03888573
Other study ID # nerve root decompression
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 1, 2019
Est. completion date September 1, 2019

Study information

Verified date March 2019
Source Cairo University
Contact Abeer Farag Hanafy, Lecturer
Phone 01063044443
Email abeerfarag22@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date September 1, 2019
Est. primary completion date August 1, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years to 50 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Stretching protocol
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

References & Publications (2)

Caridi JM, Pumberger M, Hughes AP. Cervical radiculopathy: a review. HSS J. 2011 Oct;7(3):265-72. Epub 2011 Sep 9. — View Citation

Graham N, Gross A, Goldsmith CH, Klaber Moffett J, Haines T, Burnie SJ, Peloso PM. Mechanical traction for neck pain with or without radiculopathy. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD006408. doi: 10.1002/14651858.CD006408.pub2. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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