NCT02639104

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 24, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

December 28, 2015

Status Verified

December 1, 2015

Enrollment Period

3 months

First QC Date

December 8, 2015

Last Update Submit

December 24, 2015

Conditions

Keywords

neck paincervical lordosislong thoracic nerve

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 hour

Study Arms (2)

Cervical postural related neck pain

EXPERIMENTAL

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: RadiographyOther: Electromyography

Control group

SHAM COMPARATOR

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

Radiation: RadiographyOther: Electromyography

Interventions

RadiographyRADIATION

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

Cervical postural related neck painControl group

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.

Cervical postural related neck painControl group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University Konya Hospital

Konya, 42080, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Neck Pain

Interventions

X-RaysNeurofeedback

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, IonizingBiofeedback, PsychologyMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Officials

  • Cem Yılmaz, M.D.

    Baskent University, Department of Neurosurgery

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

December 8, 2015

First Posted

December 24, 2015

Study Start

December 1, 2015

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

December 28, 2015

Record last verified: 2015-12

Locations