What is the Preferred Angle of Traction to Decompress Cervical Nerve Roots?
1 other identifier
interventional
45
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2019
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2019
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedFirst Posted
Study publicly available on registry
April 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedApril 2, 2019
March 1, 2019
4 months
March 30, 2019
March 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Flexor Carpi radialis H-reflex
The peak-to-peak amplitudes of four FCR-HR traces will be measured and averaged for each patient
Changes from Baseline to 6-weeks after treatment
Study Arms (3)
traction therapy from neutral position
ACTIVE COMPARATORPatients in this group will receive traction decompression from neutral neck position with rope angle (0°)
traction therapy from lateral bending
ACTIVE COMPARATORpatients will undergo traction decompression from (30°) lateral bending of the neck toward the non-affected side
traction from flexion with lateral bending and rotation
ACTIVE COMPARATORpatients will be treated with traction decompression from (15°) neck flexion, (30°) lateral bending toward non- affected side and (15°) rotation to the affected side.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Related Publications (2)
Khan RR, Awan WA, Rashid S, Masood T. A randomized controlled trial of intermittent Cervical Traction in sitting Vs. Supine position for the management of Cervical Radiculopathy. Pak J Med Sci. 2017 Nov-Dec;33(6):1333-1338. doi: 10.12669/pjms.336.13851.
PMID: 29492054BACKGROUNDLiu J, Ebraheim NA, Sanford CG Jr, Patil V, Elsamaloty H, Treuhaft K, Farrell S. Quantitative changes in the cervical neural foramen resulting from axial traction: in vivo imaging study. Spine J. 2008 Jul-Aug;8(4):619-23. doi: 10.1016/j.spinee.2007.04.016. Epub 2007 Jun 21.
PMID: 17697801BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Biomechanics
Study Record Dates
First Submitted
March 30, 2019
First Posted
April 2, 2019
Study Start
April 1, 2019
Primary Completion
August 1, 2019
Study Completion
September 1, 2019
Last Updated
April 2, 2019
Record last verified: 2019-03