NCT03888573

Brief Summary

The purpose of the study is to compare the effects of traction decompression and neck muscle stretching on the magnitude of Flexor Carpi Radialis H-Reflex(HR), Neck Disability Index (NDI), and Visual Analogue Scale (VAS) pain scores 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
30

participants targeted

Target at below P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 25, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 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

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

4 months

First QC Date

March 20, 2019

Last Update Submit

March 24, 2019

Conditions

Keywords

Stretching, Traction Decompression

Outcome Measures

Primary Outcomes (1)

  • The Flexor Carpi radialis H-reflex

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

    change from Baseline after 6-week of treament

Secondary Outcomes (2)

  • The Visual Analogue Scale Pain Scores(VAS)

    Change from Baseline after 6-week of treament

  • The Neck Disability Index (NDI)

    Change from Baseline after 6-week of treatment

Study Arms (2)

Stretch

ACTIVE COMPARATOR

Patients within Stretch Group will receive stretching protocols to the cervical musculature at the side of symptoms.

Other: Stretching protocol

Traction

ACTIVE COMPARATOR

Patients within Traction Group will be treated with traction from 15-degree flexion, 30-degree lateral bending, and 15-degree rotation toward the painful side.

Other: Stretching protocol

Interventions

Patients within Stretch Group will receive stretching protocols to the cervical musculature at the side of symptoms. Traction Group will be treated with traction from 15-degree flexion, 30-degree lateral bending, and 15-degree rotation toward the painful side.

Also known as: Traction using The Triton decompression system
StretchTraction

Eligibility Criteria

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

You may qualify if:

  • Patients should have C5-C6 and C6-C7 paramedian disc protrusion manifested by unilateral symptoms in C6-C7 roots dermatome and myotomes of the upper extremities.
  • They were diagnosed as cervical disc protrusion (C5- C7) for at least three months.
  • All patients should have a second grade of disc bulge (2-3mm) which was detected from T2 axial view of MRI.

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, osteoporosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Caridi JM, Pumberger M, Hughes AP. Cervical radiculopathy: a review. HSS J. 2011 Oct;7(3):265-72. doi: 10.1007/s11420-011-9218-z. Epub 2011 Sep 9.

    PMID: 23024624BACKGROUND
  • Graham N, Gross A, Goldsmith CH, Klaber Moffett J, Haines T, Burnie SJ, Peloso PM. Mechanical traction for neck pain with or without radiculopathy. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD006408. doi: 10.1002/14651858.CD006408.pub2.

    PMID: 18646151BACKGROUND

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Samiha Hafez 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
  • Salam Mohamed Elhafez, Prof.

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

    STUDY DIRECTOR

Central Study Contacts

Abeer Farag Hanafy, Lecturer

CONTACT

Mahmoud Mohamed Aly, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be randomly assigned into two groups; A and B. Patients within Group (A) will receive stretching protocols to the cervical musculature at the side of symptoms. Group (B) will be treated with traction from 15-degree flexion, 30-degree lateral bending, and 15-degree rotation toward the painful side.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Biomechanics

Study Record Dates

First Submitted

March 20, 2019

First Posted

March 25, 2019

Study Start

April 1, 2019

Primary Completion

August 1, 2019

Study Completion

September 1, 2019

Last Updated

March 26, 2019

Record last verified: 2019-03