The aim of this study is to assess the position and alignment of the Atlas, as measured by the angles between the atlas and the surrounding vertebrae in healthy participants, patients with tension headache, and patients with chronic whiplash-…
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main primary endpoints are the repeatability of the assessment of the
position and alignment of the Atlas (C1) as measured by the angles between the
atlas and the surrounding vertebrae in healthy control participants, and the
difference in atlas geometry between the two patient groups and the healthy
control participants.
Secondary outcome
Secondary endpoints include the assessment of the fat percentage of the
suboccipital muscles and the blood flow in the carotid and vertebral arteries,
as well as the quantification of differences between the groups. The study's
secondary endpoint is established through a neurological examination, physical
asymmetry test and questionnaires. Questionnaires are utilized to obtain a
quantitative indication of participants' pain experiences, subsequently
allowing correlation with the position of the atlas. Additionally, the
differences in all these parameters between before and after physiotherapy will
be quantified.
Background summary
Whiplash describes the mechanism of injury consisting of
acceleration-deceleration mechanisms of energy transfer to the neck, which can
lead to various bone or soft tissue injuries and associated symptoms. One of
the possible causes of these chronic complaints may be that the soft tissue
structures are affected. Recent research has shown increased levels of fat
infiltration into the muscles and decreases in muscle volume and
cross-sectional area (CSA). However, these findings do not fully explain the
pain and other complaints. In addition to the soft tissue structures, bony
structures, such as the cervical spine, can also be injured by whiplash.
However, until now little attention has been paid to the cervical spine, mainly
focusing on fractures, but without regard to the position and alignment of the
atlas and dens (C1 and C2). The movement of the cervical spine has been studied
previously, mainly using CT and MRI. These studies have shown that it would be
efficient to study the movement of the cervical spine three-dimensionally. To
determine the displacement and movement of the atlas, anatomical points were
visually selected to create a local coordinate system. This local coordinate
system in combination with automatic segmentation was used to quantify the
movements and displacements of the cervical spine. However, the alignment of
the Atlas in a neutral position has not yet been investigated. The coordinate
system mentioned above may provide insight into the position and alignment of
the Atlas.
Study objective
The aim of this study is to assess the position and alignment of the Atlas, as
measured by the angles between the atlas and the surrounding vertebrae in
healthy participants, patients with tension headache, and patients with chronic
whiplash-associated disorder (WAD) (grade 1 or 2), and to correlate outcome
measures such as pain intensity, neck restriction, daily activities, overall
improvement, and quality of life. Additionally, the effect of physiotherapy on
the position and alignment of the Atlas and surrounding tissues will be studied.
Specifically, our objectives are:
i. To investigate the feasibility and repeatability of advanced MRI
measurements in 30 healthy control participants aged 18-75.
ii. To evaluate the position and alignment of the Atlas and surrounding tissues
using MRI in patients with chronic WAD, comparing them to patients with tension
headache and healthy control participants.
iii. To correlate these MRI parameters with neurological examinations, physical
asymmetry and questionnaires (patient-reported outcome measures) in patients
with WAD and tension headache, aiming to assess sensitivity. Additionally, we
will study the effect of physiotherapy on the MR outcome measures and other
test outcomes mentioned above.
Study design
2-way prospective observational repeatability study.
Study burden and risks
Participants will be asked to visit the hospital one or two times. During these
visits an MRI acquisition is performed in rest. All participants are also asked
to complete questionnaires and undergo a neurological examination. There are no
medical risks associated with this study. The MRI scan is safe and painless. An
MRI scan does not emit ionizing radiation and no drugs will be administered.
The scanner does make a lot of noise, so we will give the participants hearing
protection to reduce the noise. There is a significant time investment on
behalf of the participants, since most of the participants are required to
visit the institute on two occasions. Healthy participants visit the institute
twice, with the first visit lasting about 3 hours and the second 1.5 hours. For
patients undergoing physiotherapeutic treatment, the second visit lasts about 2
hours (because, in addition to the MRI, a number of other tests are repeated).
Participants will receive reimbursement for their travel and parking costs.
Participants have no direct benefit by participating in this study. A
group-related benefit of this observational study is that in the future these
MR acquisitions might become a valuable tool in research and management of
chronic whiplash associated disorder.
.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Phase 1
Control participants
• Healthy individuals
• Ability to follow test instructions
• Aged between 18 - 75 years
Phase 2
Chronic Whiplash Associated Disorder
• Healthy individuals
• Ability to follow test instructions
• WAD 1 or 2 Diagnosis
• Aged between 18 - 75 years
• Individuals who are planning to start physiotherapy
Tension headache
• Healthy individuals
• Ability to follow test instructions
• Diagnosis Tension headache
• Aged between 18 - 75 years
• Of which 15 are planning to start physiotherapy.
Exclusion criteria
• Inability to provide informed consent
• Have a history of claustrophobia
• Patient/ participant is not eligible to follow instructions
• Contra-indication for MRI (e.g., pacemaker, Claustrophobia; See F1
vragenlijsten screening MRI Amsterdam UMC)
• Being under investigation for non-diagnosed disease at the time of
investigation
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL84857.018.23 |