Back to resultsStretching Versus Traction in Patients With Cervical Radiculopathy.
Primary Purpose
Cervical Radiculopathy
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Stretching protocol
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Radiculopathy focused on measuring Stretching, Traction Decompression
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Stretch
Traction
Arm Description
Patients within Stretch Group will receive stretching protocols to the cervical musculature at the side of symptoms.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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%
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03888573
Brief Title
Stretching Versus Traction 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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Anticipated)
Primary Completion Date
August 1, 2019 (Anticipated)
Study Completion Date
September 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Radiculopathy
Keywords
Stretching, Traction Decompression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stretch
Arm Type
Active Comparator
Arm Description
Patients within Stretch Group will receive stretching protocols to the cervical musculature at the side of symptoms.
Arm Title
Traction
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Stretching protocol
Other Intervention Name(s)
Traction using The Triton decompression system
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Flexor Carpi radialis H-reflex
Description
The peak-to-peak amplitudes of the four FCR-HR traces will be measured and averaged for each patient
Time Frame
change from Baseline after 6-week of treament
Secondary Outcome Measure Information:
Title
The Visual Analogue Scale Pain Scores(VAS)
Description
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.
Time Frame
Change from Baseline after 6-week of treament
Title
The Neck Disability Index (NDI)
Description
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%
Time Frame
Change from Baseline after 6-week of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abeer Farag Hanafy, Lecturer
Phone
01063044443
Email
abeerfarag22@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud Mohamed Aly, Master
Phone
0237617691
Email
dr3mpt@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samiha Hafez Hassan, Prof.
Organizational Affiliation
Professor of Physical Therapy for Neurology, Department of Physical Therapy for Neuromuscular Disorder and its Surgery, Faculty of Physical Therapy, Cairo University.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Salam Mohamed Elhafez, Prof.
Organizational Affiliation
Professor and Head of Department of Biomechanics, Faculty of Physical Therapy, Cairo University, Egypt.
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
23024624
Citation
Caridi JM, Pumberger M, Hughes AP. Cervical radiculopathy: a review. HSS J. 2011 Oct;7(3):265-72. doi: 10.1007/s11420-011-9218-z. Epub 2011 Sep 9.
Results Reference
background
PubMed Identifier
18646151
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.
Results Reference
background
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Stretching Versus Traction in Patients With Cervical Radiculopathy.
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