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What is the Preferred Angle of Traction to Decompress Cervical Nerve Roots?

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ClinicalTrials.gov Identifier: NCT03898739
Recruitment Status : Unknown
Verified March 2019 by Abeer Farag Hanafy, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Abeer Farag Hanafy, Cairo University

Study Description
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Brief Summary:
The purpose of the study is to investigate the effect of different angles of decompression on the Flexor Carpi Radialis (FCR) H-Reflex in patients with cervical radiculopathy

Condition or disease Intervention/treatment Phase
Cervical Radiculopathy Other: Cervical Traction from different angles Not Applicable

Detailed Description:
Cervical traction has long been defined as a distracting force that separate the cervical segments and relieve nerve roots compression. Yet, there is lack of knowledge that reports the effects of different traction decompression angles and determines the proper angle of pull among different angles of decompression system
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: One independent variable with many levels.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: patients with cervical radiculopathy, caused by cervical paramedian disc protrusion at C5-C6 or C6-C7 levels will participate in the study. They will be assigned randomly into three equal groups; A, B and C.
Primary Purpose: Treatment
Official Title: What is the Preferred Angle of Traction to Decompress Cervical Nerve Roots?
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : September 1, 2019
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: traction therapy from neutral position
Patients in this group will receive traction decompression from neutral neck position with rope angle (0°)
 Other: Cervical Traction from different angles
Intermittent traction will be applied, maximum force will be 16 kg, minimum force will be 12 kg, traction cycle of each minute consists of 20 seconds static traction at the maximum force then released down to the minimum force for 20 seconds then repeated for 20 seconds static traction. Traction session time will be 15 minutes, and the traction force will be increased progressively with speed (50%) of increment of force
Active Comparator: traction therapy from lateral bending
patients will undergo traction decompression from (30°) lateral bending of the neck toward the non-affected side
 Other: Cervical Traction from different angles
Intermittent traction will be applied, maximum force will be 16 kg, minimum force will be 12 kg, traction cycle of each minute consists of 20 seconds static traction at the maximum force then released down to the minimum force for 20 seconds then repeated for 20 seconds static traction. Traction session time will be 15 minutes, and the traction force will be increased progressively with speed (50%) of increment of force
Active Comparator: traction from flexion with lateral bending and rotation
patients will be treated with traction decompression from (15°) neck flexion, (30°) lateral bending toward non- affected side and (15°) rotation to the affected side.
 Other: Cervical Traction from different angles
Intermittent traction will be applied, maximum force will be 16 kg, minimum force will be 12 kg, traction cycle of each minute consists of 20 seconds static traction at the maximum force then released down to the minimum force for 20 seconds then repeated for 20 seconds static traction. Traction session time will be 15 minutes, and the traction force will be increased progressively with speed (50%) of increment of force


Outcome Measures
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Primary Outcome Measures :
  1. The Flexor Carpi radialis H-reflex [ Time Frame: Changes from Baseline to 6-weeks after treatment ]
    The peak-to-peak amplitudes of four FCR-HR traces will be measured and averaged for each patient


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients will be included in the study if they have C5-C6 and C6-C7 paramedian disc protrusion manifested by unilateral symptoms in C6-C7 roots dermatome and myotomes of the upper extremities, second grade of disc bulge (2-3mm) which was detected from T2 axial view of MRI, and diagnosed as cervical disc protrusion (C5- C7) for at least three months.

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, osteoporotic patients.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898739


Contacts
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Contact: Abeer F Hanafy, PhD 01063044443 abeerfarag22@gmail.com
Contact: Mahmoud M Aly, Master 0237617691 dr3mpt@yahoo.com

Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: Samiha H 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: Shaymaa M Abdelmeged, PhD Lecturer at Department of Physical Therapy for Neuromuscular Disorder and its Surgery, Faculty of Physical Therapy, Cairo University.
Study Chair: Salam M Elhafez, Prof. Professor and Head of Department of Biomechanics, Faculty of Physical Therapy, Cairo University, Egypt
More Information
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Publications:

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Responsible Party: Abeer Farag Hanafy, Lecturer of Biomechanics, Cairo University
ClinicalTrials.gov Identifier: NCT03898739    
Other Study ID Numbers: Traction decompression angle
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abeer Farag Hanafy, Cairo University:
Traction
Decompression angles
Additional relevant MeSH terms:
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Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases