- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02639104
Could Cervical Postural Changes Affect the Long Thoracic Nerve Electromyographic Findings?
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Konya, Turkey, 42080
- Baskent University Konya Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Obtaining patients lateral spot cervical spine radiography and will measure;
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
|
Obtaining patients lateral spot cervical spine radiography and will measure;
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 hour
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Cem Yılmaz, M.D., Baskent University, Department of Neurosurgery
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KA15-220
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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