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

March 30, 2019 updated by: Abeer Farag Hanafy, Cairo University
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Changes from Baseline to 6-weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 30, 2019

First Submitted That Met QC Criteria

March 30, 2019

First Posted (Actual)

April 2, 2019

Study Record Updates

Last Update Posted (Actual)

April 2, 2019

Last Update Submitted That Met QC Criteria

March 30, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Traction decompression angle

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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