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

Primary Purpose

Cervicalgia

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Radiography
Electromyography
Sponsored by
Baskent University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervicalgia focused on measuring neck pain, cervical lordosis, long thoracic nerve

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Baskent University Konya Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Cervical postural related neck pain

Control group

Arm Description

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.

The healthy volunteers recruit in this group. All inviduals will undergo lateral cervical spot radiography and serratus anterior needle electromypography

Outcomes

Primary Outcome Measures

Visual Analogue Scale
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.

Secondary Outcome Measures

Full Information

First Posted
December 8, 2015
Last Updated
December 24, 2015
Sponsor
Baskent University
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1. Study Identification

Unique Protocol Identification Number
NCT02639104
Brief Title
Could Cervical Postural Changes Affect the Long Thoracic Nerve Electromyographic Findings?
Official Title
Could Cervical Postural Changes Affect the Long Thoracic Nerve Electromyographic Findings?
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
April 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicalgia
Keywords
neck pain, cervical lordosis, long thoracic nerve

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cervical postural related neck pain
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
The healthy volunteers recruit in this group. All inviduals will undergo lateral cervical spot radiography and serratus anterior needle electromypography
Intervention Type
Radiation
Intervention Name(s)
Radiography
Intervention Description
Obtaining patients lateral spot cervical spine radiography and will measure; The segmental angle will be measured from C2-C7 inferior endplates on the lateral radiography 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 The segmental cobb angle will be measured between C2-C4 inferior endplates and C4-C7 inferior endplates
Intervention Type
Other
Intervention Name(s)
Electromyography
Intervention Description
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 Measure Information:
Title
Visual Analogue Scale
Description
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.
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cem Yılmaz, M.D.
Organizational Affiliation
Baskent University, Department of Neurosurgery
Official's Role
Study Director
Facility Information:
Facility Name
Baskent University Konya Hospital
City
Konya
ZIP/Postal Code
42080
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25683111
Citation
Castelein B, Cools A, Bostyn E, Delemarre J, Lemahieu T, Cagnie B. Analysis of scapular muscle EMG activity in patients with idiopathic neck pain: a systematic review. J Electromyogr Kinesiol. 2015 Apr;25(2):371-86. doi: 10.1016/j.jelekin.2015.01.006. Epub 2015 Jan 31.
Results Reference
result

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

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