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

NCT ID: NCT03898739

Last Updated: 2019-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2019-09-01

Brief Summary

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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

Detailed Description

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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

Conditions

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Cervical Radiculopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

One independent variable with many levels.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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traction therapy from neutral position

Patients in this group will receive traction decompression from neutral neck position with rope angle (0°)

Group Type ACTIVE_COMPARATOR

Cervical Traction from different angles

Intervention Type OTHER

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

traction therapy from lateral bending

patients will undergo traction decompression from (30°) lateral bending of the neck toward the non-affected side

Group Type ACTIVE_COMPARATOR

Cervical Traction from different angles

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Cervical Traction from different angles

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Abeer Farag Hanafy

Lecturer of Biomechanics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Samiha H Hassan, Prof.

Role: STUDY_CHAIR

Professor of Physical Therapy for Neurology, Department of Physical Therapy for Neuromuscular Disorder and its Surgery, Faculty of Physical Therapy, Cairo University.

Shaymaa M Abdelmeged, PhD

Role: STUDY_DIRECTOR

Lecturer at Department of Physical Therapy for Neuromuscular Disorder and its Surgery, Faculty of Physical Therapy, Cairo University.

Salam M Elhafez, Prof.

Role: STUDY_CHAIR

Professor and Head of Department of Biomechanics, Faculty of Physical Therapy, Cairo University, Egypt

Central Contacts

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Abeer F Hanafy, PhD

Role: CONTACT

01063044443

Mahmoud M Aly, Master

Role: CONTACT

0237617691

References

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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.

Reference Type BACKGROUND
PMID: 29492054 (View on PubMed)

Liu 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.

Reference Type BACKGROUND
PMID: 17697801 (View on PubMed)

Other Identifiers

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Traction decompression angle

Identifier Type: -

Identifier Source: org_study_id

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