Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02560675 |
| Other study ID # |
601-14-RMB Whiplash_CTIL |
| Secondary ID |
597-14-RMB Gene_ |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 2016 |
| Est. completion date |
September 15, 2021 |
Study information
| Verified date |
April 2024 |
| Source |
Rambam Health Care Campus |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Why does acute post whiplash injury pain transform into chronic pain? Multi-modal assessment
of risk factors and predictors of pain chronification
Description:
Background
The proposed study aims to explore why acute pain turns, in some patients, into chronic pain,
and to develop tools for prediction of this transition. Based on the clinical and
psychological assessment along with psychophysical and neurophysiological assessment of pain
perception, with the analysis of connectivity between several brain centers relevant for pain
processing, together with pain genetics, we expect to develop a tool, that will predict, for
the individual patient with acute pain inflicted by a whiplash injury, what are the chances
for him/her to go into chronic pain situation. Further, by knowing the dysfunctions of pain
processing that a patient has, it will be possible to offer the treatment of highest chances
to succeed.
Our specific aims are to evaluate, in the setup of acute whiplash injury, the risk of
transition to chronic pain based on each of the following testing domains: (i) Psychophysical
and neurophysiological data describing facilitatory and inhibitory modulation capacity of the
patient. (ii) Psychological data describing patient's behavior such as catastrophizing, fear
of pain, post-traumatic stress and depressed mood. (iii) Structural and functional
neuro-imaging data describing brain anatomy and function, where we assess resting state MRI
activity, grey matter properties using T1 weighted imaging, and white matter properties using
diffusion tensor imaging. (iv) Genetic data describing the genetic epidemiology of every
patient for the examination of genetic variants associated with transition to chronic pain,
and (v) individual case data related to age, gender, education, socioeconomic parameters and
personal medical history, as well as features of the specific injury. Overall, we aim to
construct a composite scoring system, based on the most relevant of the above mentioned
parameters, yielding the highest relative predictive value in identifying acute pain patients
who have higher risk for chronification.
Subjects One hundred and twenty healthy subjects (range 20-79; 20 subjects per age decade, 10
M and 10 F) will participate in the first phase of the study aimed to collect normative data
from healthy population.
Seven hundred and fifty acute whiplash-injury based mild traumatic brain injuries (TBI) will
participate in this study.
Study design Phase I - Normative data collection for the inhibitory and excitatory pain
modulation responses, a study on healthy subjects
Phase II - Multi-modal assessment of acute mild TBI whiplash patients and follow-up
1. Initial experimental assessment, will consist, in most cases, of two sessions, one
during the ER visit, and the next within 72 hrs of injury, pending on team and device
availability, such that all tests will be completed, as follows:
1. Physical examination with a full neurological exam, and assessment of neck
movement.
2. Psychophysical pain measurements:
i. Pain thresholds. ii. Suprathreshold pain magnitude estimation; iii. Mechanical
temporal summation (TS) and electrical TS iv. Conditioned pain modulation (CPM) - as
described for the phase I protocol. It is noted that similar protocols of pain
measurement are commonly performed in many labs worldwide in many acute and chronic pain
setups, and are considered safe, with no damaging effect on the disease state.
c. Psychological examination via filling questionnaires for evaluation the following
variables: i. Pain Catastrophizing ii. Depression iii. Post-traumatic Diagnostic Scale
(PDS) iv. Fear of pain v. The perceived stress of the subjects is assessed by the
validated Hebrew version Cohen's Perceived Stress Scale (PSS).
vi. Five factor model (FFM)
d.Blood collection for genetics. Whole blood sample (10cc) will be collected from each
subject and placed in Ethylenediaminetetraacetic acid (EDTA)-coated tubes. Genomic DNA
will be isolated using DNA Extraction Kit . Quality and quantity of the DNA sample will
be measured using a NanoDrop Machine.
e. Magnetic resonance imaging (MRI)/Functional MRI (fMRI) examination in a 3T scanner.
f. Neurophysiological assessment of pain modulation with 64-channel EEG recording (Brain
Products GmbH, Munich, Germany) of CPM and TS.
i.Neurophysiological assessment of CPM ii.Neurophysiological assessment of TS will be
based on electrical evoked potentials obtained with a constant current stimulator
2. Follow up Patients will self-report their pain levels and use of analgesics once in two
weeks.
At 6 and 12 month visits patients will be invited to repeat the psychophysical and
neurophysiological pain assessments and psychological questionnaires. Selected patients will
undergo a second MRI assessment.
