NCT03489954

Brief Summary

The aims of this research are to investigate relationship of deep cervical flexor muscle endurance with neck position sense and body balance in non-specific chronic neck pain, and to compare the results with healthy individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2018

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 6, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2020

Completed
Last Updated

August 5, 2020

Status Verified

August 1, 2020

Enrollment Period

1.8 years

First QC Date

March 25, 2018

Last Update Submit

August 4, 2020

Conditions

Keywords

Chronic Neck PainBalance MasterJoint Position ErrorEndurance

Outcome Measures

Primary Outcomes (1)

  • Endurance of deep cervical flexor muscles

    Score of cranio-cervical flexion test will be measured by Stabilizer Pressure Biofeedback Unit.

    Baseline

Secondary Outcomes (8)

  • Neck position sense

    Baseline

  • Modified clinical test of sensory interaction balance (mCTSIB)

    Baseline

  • Limits of stability (LOS)

    Baseline

  • Rhythmic weight shift (RWS)

    Baseline

  • Unilateral stance (US)

    Baseline

  • +3 more secondary outcomes

Study Arms (2)

Non-specific chronic neck pain group

In evaluation of participants, endurance of deep cervical flexor muscles will be measured using stabilizer pressure biofeedback unit with cranio-cervical flexion test. Neck position sense of 6-direction (flexion, extension, right-left lateral flexion and right-left rotation) will be measured by CROM device (cervical range of motion device). Body balace will be measured by Balance Master System.

Other: Evaluation

Healthy group

In evaluation of participants, endurance of deep cervical flexor muscles will be measured using stabilizer pressure biofeedback unit with cranio-cervical flexion test. Neck position sense of 6-direction (flexion, extension, right-left lateral flexion and right-left rotation) will be measured by CROM device (cervical range of motion device). Body balace will be measured by Balance Master System.

Other: Evaluation

Interventions

Deep cervical flexor muscle endurance, neck position sense and body balance will be measured.

Healthy groupNon-specific chronic neck pain group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals in Dokuz Eylul University Health Campus

You may qualify if:

  • Non-specific chronic neck pain for at least 3 months
  • Neck pain is at most 7/10 according to VAS

You may not qualify if:

  • Musculoskeletal treatment for neck complaints or balance within the last 3 months
  • Musculoskeletal disease that may affect balance
  • Spine, upper or lower limb fractures or surgical history
  • Diagnosis of vestibular disorder
  • Diagnosis of neurological or systemic musculoskeletal disease
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University

Balçova, İzmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sevgi Sevi YESILYAPRAK, PhD

    Dokuz Eylul University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 25, 2018

First Posted

April 6, 2018

Study Start

March 1, 2018

Primary Completion

December 30, 2019

Study Completion

January 20, 2020

Last Updated

August 5, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations