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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03489954
Other study ID # 3411-GOA
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2018
Est. completion date January 20, 2020

Study information

Verified date August 2020
Source Dokuz Eylul University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

The investigation will be included 2 groups which include 30 individuals with non-specific chronic neck pain and 30 healthy individuals. In evaluation of participants, endurance of deep cervical flexor muscles will be measured using Stabilizer Pressure Biofeedback Unit with cranio-cervical flexion test. Pressure rise which increases from 20 mmHg to 30 mmHg with 2 mmHg increments will be performed in 5 stages. There are 10 seconds contractions at every stage and these contractions will be made 10 times. Endurance will be calculated by the cumulative performance index with the information obtained from this 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). Joint position error will be calculated by taking the average of the absolute angular difference by 3 trial for each direction. Body balace will be measured by Balance Master System. Modified clinical test of sensory interaction balance (mCTSIB), limits of stability (LOS), rhythmic weight shift (RWS), unilateral stance (US), walk across (WA) and step/quick turn (SQT) will be performed.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 20, 2020
Est. primary completion date December 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Non-specific chronic neck pain for at least 3 months

- Neck pain is at most 7/10 according to VAS

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Dokuz Eylul University Balçova Izmir

Sponsors (1)

Lead Sponsor Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Endurance of deep cervical flexor muscles Score of cranio-cervical flexion test will be measured by Stabilizer Pressure Biofeedback Unit. Baseline
Secondary Neck position sense Joint position error of 6-direction (flexion, extension, right-left lateral flexion and right-left rotation) will be measured by cervical range of motion device (CROM device). Baseline
Secondary Modified clinical test of sensory interaction balance (mCTSIB) This test will be measured by Balance Master System. Baseline
Secondary Limits of stability (LOS) This test will be measured by Balance Master System. Baseline
Secondary Rhythmic weight shift (RWS) This test will be measured by Balance Master System. Baseline
Secondary Unilateral stance (US) This test will be measured by Balance Master System. Baseline
Secondary Walk across (WA) This test will be measured by Balance Master System. Baseline
Secondary Step/quick turn (SQT) This test will be measured by Balance Master System. Baseline
Secondary Pain This test will be measured by Visual Analog Scale (VAS) score in activity and rest. VAS has 10-centimeter line corresponding to the amount of pain they experienced. "0" means "no pain" and "10" means "pain as bad as possible". Baseline
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