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

• ClinicalTrials.gov Identifier: NCT02639104
• Recruitment Status: Unknown
• First Posted: December 24, 2015
• Last Update Posted: December 28, 2015
• Sponsor: Baskent University
• Information provided by (Responsible Party): Atilla Kircelli, Baskent University

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.

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.

Study Design

• 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

Arms and Interventions

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; 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; 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; 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; 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.

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Turkey

Baskent University Konya Hospital

Konya, Turkey, 42080

Sponsors and Collaborators

Baskent University

Investigators

• Study Director: Cem Yılmaz, M.D.; Baskent University, Department of Neurosurgery

More Information

Publications of Results:

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. Review.

• Responsible Party: Atilla Kircelli, M.D., Baskent University
• ClinicalTrials.gov Identifier: NCT02639104
• Other Study ID Numbers: KA15-220
• First Posted: December 24, 2015
• 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:

Neck Pain; Pain; Neurologic Manifestations