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Could Cervical Postural Changes Affect the Long Thoracic Nerve Electromyographic Findings?

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ClinicalTrials.gov Identifier: NCT02639104
Recruitment Status : Unknown
Verified December 2015 by Atilla Kircelli, Baskent University.
Recruitment status was:  Active, not recruiting
First Posted : December 24, 2015
Last Update Posted : December 28, 2015
Sponsor:
Information provided by (Responsible Party):
Atilla Kircelli, Baskent University

Brief Summary:
This study investigates one of the mechanism factors of neck pain. Cervical lordotic angle alterations affect the tension of serratus anterior muscle. Expected result that the long thoracic nerve can be affected in this situation, and could be observed the functional changes of the nerve with serratus anterior electromyographic findings.

Condition or disease Intervention/treatment Phase
Cervicalgia Radiation: Radiography Other: Electromyography Not Applicable

Detailed Description:

Different methods exist in order to evaluate muscle function. For the neck pain, the most commonly used method by researchers and clinicians are spot radiography and surface electromyography (sEMG). Radiographs can be used for the kyphotic angle or cervical lordotic angle measurements. Parameters that can be studied by EMG are amplitude, timing, conduction velocity, fatigability and characteristic frequencies/patterns.

The long thoracic nerve innervates the serratus anterior muscle. This nerve arises from the anterior rami of three spinal nerve roots: the fifth, sixth, and seventh cervical nerves (C5-C7) The nerve descends through the cervicoaxillary canal behind (posterior to) the brachial plexus and the axillary artery and vein, resting on the outer surface of the serratus anterior. The Serratus anterior electromyography, the needle can be inserted into the muscle superficially to the fourth to sixth rib in the medial or posterior axillary line. The usual nerve latency time is between 2.6-4 ms.

In this study, the results of serratus anterior muscle EMG activity and postural cervical angle alterations (lateral radiography) in patients with chronic mechanical neck pain will be compared with healthy volunteers without neck pain.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Could Cervical Postural Changes Affect the Long Thoracic Nerve Electromyographic Findings?
Study Start Date : December 2015
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cervical postural related neck pain
Patients recruit in this group who has a neck pain without radiculopathy. If the patient examination shows neurologic deficits, this patient will exclude in this study. All patients will undergo lateral cervical spine spot radiography and serratus anterior needle electromyography. Cervical segmental angle measurements will be done in all patients.
Radiation: Radiography

Obtaining patients lateral spot cervical spine radiography and will measure;

  1. The segmental angle will be measured from C2-C7 inferior endplates on the lateral radiography
  2. If there is a segmental kyphosis (for example kyphotic angle in C4-5 level), the segmental cobb angle will be measured in the level of the main kyphosis
  3. The segmental cobb angle will be measured between C2-C4 inferior endplates and C4-C7 inferior endplates

Other: Electromyography

Serratus anterior needle electromyography:

The needle can be inserted into the muscle superficially to the fourth to sixth rib in the medial or posterior axillary line. The usual nerve latency time is between 2.6-4 ms.


Sham Comparator: Control group
The healthy volunteers recruit in this group. All inviduals will undergo lateral cervical spot radiography and serratus anterior needle electromypography
Radiation: Radiography

Obtaining patients lateral spot cervical spine radiography and will measure;

  1. The segmental angle will be measured from C2-C7 inferior endplates on the lateral radiography
  2. If there is a segmental kyphosis (for example kyphotic angle in C4-5 level), the segmental cobb angle will be measured in the level of the main kyphosis
  3. The segmental cobb angle will be measured between C2-C4 inferior endplates and C4-C7 inferior endplates

Other: Electromyography

Serratus anterior needle electromyography:

The needle can be inserted into the muscle superficially to the fourth to sixth rib in the medial or posterior axillary line. The usual nerve latency time is between 2.6-4 ms.





Primary Outcome Measures :
  1. Visual Analogue Scale [ Time Frame: 1 hour ]
    Pain is a sensory and emotional experience, modified by multiple factors, including meaning, context, previous pain experience, culture, gender, expectation, anxiety, depression, fear, family and social factors. Patients admitted to hospital experience a high prevalence of moderate and severe pain. The VAS (Visual Analog Scale, 0 mm "no pain", to 100 mm," the worst pain possible ") is used to assess chronic neck pain. The authors aim to find a correlation between factors either neck pain (with VAS), cervical lordosis angle and long thoracic nerve electrophysiological results.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient whose age is > to 18 years and <40 yo
  • Patient presenting a chronic neck pain (symptoms over 3 months)
  • No neurological deficit
  • Asymptomatic volunteers (for control group)
  • Obtaining the enlightened consent of the patient

Exclusion Criteria:

  • Patient having refused to sign his consent
  • Patients whose age is < to 18 years or >40 yo.
  • Patients with neurologic deficits
  • Patients presenting history of allergy
  • History of cervical spine surgery
  • Patient presenting an anticoagulant or salicylated treatment which can not be interrupted.
  • Pregnant woman.
  • Patient with acute head and neck trauma
  • Patient with a contra-indication to radiography.
  • Patient with a psychiatric pathology preventing a clinical evaluation.
  • Patient with contra-indication (cutaneous or different) to needle electromyography.
  • Surgery contra-indication (cardiac failure, respiratory…)
  • Patient without health coverage.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639104


Locations
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Turkey
Baskent University Konya Hospital
Konya, Turkey, 42080
Sponsors and Collaborators
Baskent University
Investigators
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Study Director: Cem Yılmaz, M.D. Baskent University, Department of Neurosurgery
Publications of Results:
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Responsible Party: Atilla Kircelli, M.D., Baskent University
ClinicalTrials.gov Identifier: NCT02639104    
Other Study ID Numbers: KA15-220
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: December 28, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Atilla Kircelli, Baskent University:
neck pain
cervical lordosis
long thoracic nerve
Additional relevant MeSH terms:
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Neck Pain
Pain
Neurologic Manifestations