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

Primary Purpose

Cervical Radiculopathy

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Cervical Traction from different angles

Sponsored by

Cairo University

About this trial

This is an interventional treatment trial for Cervical Radiculopathy focused on measuring Traction, Decompression angles

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

traction therapy from neutral position

traction therapy from lateral bending

traction from flexion with lateral bending and rotation

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

The Flexor Carpi radialis H-reflex

The peak-to-peak amplitudes of four FCR-HR traces will be measured and averaged for each patient

Secondary Outcome Measures

Full Information

NCT ID

First Posted

March 30, 2019

Last Updated

March 30, 2019

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03898739

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2019 (Anticipated)

Primary Completion Date

August 1, 2019 (Anticipated)

Study Completion Date

September 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Radiculopathy

Keywords

Traction, Decompression angles

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

One independent variable with many levels.

Masking

ParticipantOutcomes 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.

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

traction therapy from neutral position

Arm Type

Active Comparator

Arm Description

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

Arm Title

traction therapy from lateral bending

Arm Type

Active Comparator

Arm Description

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

Arm Title

traction from flexion with lateral bending and rotation

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Cervical Traction from different angles

Intervention Description

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

Primary Outcome Measure Information:

Title

The Flexor Carpi radialis H-reflex

Description

The peak-to-peak amplitudes of four FCR-HR traces will be measured and averaged for each patient

Time Frame

Changes from Baseline to 6-weeks after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Abeer F Hanafy, PhD

Phone

01063044443

Email

abeerfarag22@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Mahmoud M Aly, Master

Phone

0237617691

Email

dr3mpt@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Samiha H Hassan, Prof.

Organizational Affiliation

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

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Shaymaa M Abdelmeged, PhD

Organizational Affiliation

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

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Salam M Elhafez, Prof.

Organizational Affiliation

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

Official's Role

Study Chair

12. IPD Sharing Statement

Citations:

PubMed Identifier

29492054

Citation

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.

Results Reference

background

PubMed Identifier

17697801

Citation

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.

Results Reference

background

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

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