Neck PainNCT03489954
Relationship of Deep Cervical Flexor Muscle Endurance With Neck Position Sense and Body Balance
An observational study of Neck Pain, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- What is being tested?
- Evaluation
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2018to 20 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals in Dokuz Eylul University Health Campus
Who may be able to join
- Non-specific chronic neck pain for at least 3 months
- Neck pain is at most 7/10 according to VAS
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship of Deep Cervical Flexor Muscle Endurance With Neck Position Sense and Body Balance in Non-specific Chronic Neck Pain
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.
Read the detailed 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.
- Conditions
- Neck Pain
- Being tested
- Evaluation
- Keywords
- Chronic Neck Pain, Balance Master, Joint Position Error, Endurance
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvaluationOther
Deep cervical flexor muscle endurance, neck position sense and body balance will be measured.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endurance of deep cervical flexor muscles
Score of cranio-cervical flexion test will be measured by Stabilizer Pressure Biofeedback Unit.
Measured: Baseline
Secondary outcomes (8)
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).
Measured: Baseline
Modified clinical test of sensory interaction balance (mCTSIB)
This test will be measured by Balance Master System.
Measured: Baseline
Limits of stability (LOS)
This test will be measured by Balance Master System.
Measured: Baseline
Rhythmic weight shift (RWS)
This test will be measured by Balance Master System.
Measured: Baseline
Unilateral stance (US)
This test will be measured by Balance Master System.
Measured: Baseline
Walk across (WA)
This test will be measured by Balance Master System.
Measured: Baseline
Step/quick turn (SQT)
This test will be measured by Balance Master System.
Measured: Baseline
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".
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start1 Mar 2018
- Primary completion30 Dec 2019
- Study completion20 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Karadeniz, Dokuz Eylul University
- Investigators
- Sevgi Sevi YESILYAPRAK, PhD, Study director, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489954
- Sponsor's protocol ID
- 3411-GOA
- Status last verified
- Aug 2020
- First submitted
- 25 Mar 2018
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Deep Cervical Flexor Muscle Endurance With Neck Position Sense and Body Balance in Non-specific Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT03489954
- Acronym / sponsor ID
- 3411-GOA
- Conditions
- Neck Pain
- Keywords
- Chronic Neck Pain, Balance Master, Joint Position Error, Endurance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 6 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-specific chronic neck pain group | – | Other: EvaluationIn 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. |
| Healthy group | – | Other: EvaluationIn 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals in Dokuz Eylul University Health Campus
Key inclusion criteria (2 listed)
- Non-specific chronic neck pain for at least 3 months
- Neck pain is at most 7/10 according to VAS
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EvaluationDeep cervical flexor muscle endurance, neck position sense and body balance will be measured. | Other | Healthy group, Non-specific chronic neck pain group |
Primary outcome
Endurance of deep cervical flexor muscles
Time frame: Baseline
Score of cranio-cervical flexion test will be measured by Stabilizer Pressure Biofeedback Unit.
8 secondary outcomes
Neck position sense
Time frame: Baseline
Modified clinical test of sensory interaction balance (mCTSIB)
Time frame: Baseline
Limits of stability (LOS)
Time frame: Baseline
Rhythmic weight shift (RWS)
Time frame: Baseline
Unilateral stance (US)
Time frame: Baseline
Walk across (WA)
Time frame: Baseline
Step/quick turn (SQT)
Time frame: Baseline
Pain
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevgi Sevi YESILYAPRAK, PhD study director
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Pain, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endurance of deep cervical flexor muscles (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2020.