Stretching Versus Traction in Patients With Cervical Radiculopathy.

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

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.

Study Overview

• Status: Unknown
• Conditions: Cervical Radiculopathy
• Intervention / Treatment: Other: Stretching protocol

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

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Stretch; Patients within Stretch Group will receive stretching protocols to the cervical musculature at the side of symptoms.	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.; Other Names: Traction using The Triton decompression system
ACTIVE_COMPARATOR: Traction; 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; 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.; 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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Samiha Hafez Hassan, Prof., Professor of Physical Therapy for Neurology, Department of Physical Therapy for Neuromuscular Disorder and its Surgery, Faculty of Physical Therapy, Cairo University.; Study Director: Salam Mohamed Elhafez, Prof., Professor and Head of Department of Biomechanics, Faculty of Physical Therapy, Cairo University, Egypt.

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2019
• Primary Completion (ANTICIPATED): August 1, 2019
• Study Completion (ANTICIPATED): September 1, 2019

Study Registration Dates

• First Submitted: March 20, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (ACTUAL): March 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 24, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Stretching, Traction Decompression
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy
• Other Study ID Numbers: nerve root decompression

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No