NCT03898739

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Status
unknown

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

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

April 2, 2019

Status Verified

March 1, 2019

Enrollment Period

4 months

First QC Date

March 30, 2019

Last Update Submit

March 30, 2019

Conditions

Keywords

TractionDecompression angles

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 COMPARATOR

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

Other: Cervical Traction from different angles

traction therapy from lateral bending

ACTIVE COMPARATOR

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

Other: Cervical Traction from different angles

traction from flexion with lateral bending and rotation

ACTIVE COMPARATOR

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

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

traction from flexion with lateral bending and rotationtraction therapy from lateral bendingtraction therapy from neutral position

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

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: 29492054BACKGROUND
  • 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.

    PMID: 17697801BACKGROUND

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • 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 CHAIR
  • Shaymaa M Abdelmeged, PhD

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

    STUDY DIRECTOR
  • Salam M Elhafez, Prof.

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

    STUDY CHAIR

Central Study Contacts

Abeer F Hanafy, PhD

CONTACT

Mahmoud M Aly, Master

CONTACT

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
Model Details: One independent variable with many levels.
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