Neck PainNCT02452827
The Correlation of Myodural Bridges to Biomechanical Parameters in Patients Suffering From Primary Chronic Neck Pain
An observational study of Neck Pain, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
In recent years, an anatomical connection of suboccipital muscle fibers to the dura has been found in pathological studies. The physiologic function of these fibers is still unknown. 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?
- Biomechanical parameters and MRI
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2015to Dec 2015
- 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: Patients suffering from Primary Chronic Neck Pain who have undergone MRI. Healthy volunteers who have undergone MRI of the cervical spine.
Who may be able to join
- Chronic Neck Pain
Who cannot join
- Have undergone cervical spine surgery
- Known cerebral vascular disease of the carotid or vertebral arteries
- Malignant disease of the cervical spine
Trial locations and contacts
1 site in 1 country.
About this study
In recent years, an anatomical connection of suboccipital muscle fibers to the dura has been found in pathological studies. The physiologic function of these fibers is still unknown. Using Magnetic Resonance Tomography (MRI), this study will investigate whether these fibers undergo changes in patients suffering from primary chronic neck pain. In addition, the biomechanical parameters of neck movements in these patients will be correlated with the imaging findings.
- Conditions
- Neck Pain
- Being tested
- Biomechanical parameters, MRI
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomechanical parametersOther
MRIOther
MRI of cervical spine
| Study group | Role | What they receive |
|---|---|---|
| Primary Chronic Neck Pain | Patients suffering for at least 3 years from neck pain without any underlying pathology who have undergone MRI. Biomechanical parameters of neck movements will be investigated. Receives: Other: Biomechanical parameters; Other: MRI | |
| Control | Patients without neck pain who have undergone MRI for any reason. Biomechanical parameters of neck movements will be investigated. Receives: Other: Biomechanical parameters; Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume and Number of Muscle Fibers in Myodural Bridges
A composite outcome including the interpretation, counting and measurement of muscle fibers as found on MRI
Measured: One hour
Secondary outcomes (1)
Measurement of cervical range of motion
Measurements will be made using a cervical range of motion device (CROM Device)
Measured: Two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
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-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yaron River, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452827
- Sponsor's protocol ID
- HYMC-0034-15
- Status last verified
- May 2015
- First submitted
- 18 May 2015
- Last updated
- 25 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation of Myodural Bridges to Biomechanical Parameters in Patients Suffering From Primary Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT02452827
- Acronym / sponsor ID
- HYMC-0034-15
- Conditions
- Neck Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 25 May 2015 (estimated)
- 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.
In recent years, an anatomical connection of suboccipital muscle fibers to the dura has been found in pathological studies. The physiologic function of these fibers is still unknown. Using Magnetic Resonance Tomography (MRI), this study will investigate whether these fibers undergo changes in patients suffering from primary chronic neck pain. In addition, the biomechanical parameters of neck movements in these patients will be correlated with the imaging findings.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Chronic Neck Pain | – | Other: Biomechanical parameters, Other: MRIPatients suffering for at least 3 years from neck pain without any underlying pathology who have undergone MRI. Biomechanical parameters of neck movements will be investigated. |
| Control | – | Other: Biomechanical parameters, Other: MRIPatients without neck pain who have undergone MRI for any reason. Biomechanical parameters of neck movements will be investigated. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from Primary Chronic Neck Pain who have undergone MRI. Healthy volunteers who have undergone MRI of the cervical spine.
Key inclusion criteria (1 listed)
- Chronic Neck Pain
Key exclusion criteria (3 listed)
- Have undergone cervical spine surgery
- Known cerebral vascular disease of the carotid or vertebral arteries
- Malignant disease of the cervical spine
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 |
|---|---|---|
| Biomechanical parameters | Other | Control, Primary Chronic Neck Pain |
| MRIMRI of cervical spine | Other | Control, Primary Chronic Neck Pain |
Primary outcome
Volume and Number of Muscle Fibers in Myodural Bridges
Time frame: One hour
A composite outcome including the interpretation, counting and measurement of muscle fibers as found on MRI
1 secondary outcome
Measurement of cervical range of motion
Time frame: Two hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2015.
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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.
Yaron River, MD principal investigator
Hillel Yaffe Medical Center
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 Hillel Yaffe Medical Center at 1 site in Israel.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 May 2015. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yaron River, MD (972-523756446, yaronr@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume and Number of Muscle Fibers in Myodural Bridges (time frame: One hour). 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 25 May 2015.