The main objectives of this study are: A) to evaluate the differences between chronic migraine patients, episodic migraine patients an healthy controls with respect to i) pain inhibition, ii) sensory profile and iii) corneal nerve fiber parameters;…
ID
Source
Brief title
Condition
- Headaches
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Part A and part B
Primary outcome measurements for of the three aspects:
i) relative change in peak VAS score;
ii) QST parameters;
iii) corneal nerve fiber density.
& Headache frequency
Secondary outcome
Part A and B
Secondary outcomes for each of the three aspects:
i) change in area under the curve (VAS*sec) of the test stimulus during the
conditioned stimulus;
ii) no additional outcomes;
iii) corneal nerve fiber length and corneal nerve branch density.
Additional outcome measures:
- Sum scores on depression, anxiety and visual sensitivity questionnaires.
Background summary
Migraine chronification, the transition from low frequent (episodic) migraine,
to high frequent (chronic) migraine, occurs in 2.5% of migraine patients every
year. Accordingly, in the Netherlands 50.000 migraine patients convert into a
severe chronic form each year. The mechanism of migraine chronification
remains uncertain, and the pathophysiological differences between episodic
migraine and chronic migraine are to a large extent unknown. As for many
chronic pain disorders, enhanced pain facilitation (central sensitization) or
lack of pain inhibition are suggested as underlying mechanisms. Therefore, the
aim of this study is to explore different aspects of central sensitization and
pain inhibition in chronic migraine patients and episodic migraine patients
Study objective
The main objectives of this study are:
A) to evaluate the differences between chronic migraine patients, episodic
migraine patients an healthy controls with respect to i) pain inhibition, ii)
sensory profile and iii) corneal nerve fiber parameters;
B) to evaluate whether chronic migraine patients alter on these three aspects
in response to treatment;
Study design
The study consists of a cross-sectional part (part A) and a longitudinal part
(part B).
For part A, patients with chronic migraine without medication overuse and
episodic migraine will be included, and have one study session. A study session
will consist of i) Conditioned Pain Modulation; ii) Quantitative Sensory
Testing and iii) Corneal Confocal Microscopy.
In part B, chronic migraine patients with medication overuse will have a study
session containing all three measurements before and after treatment. Treatment
is regular care and consists of three months withdrawal of overused medication.
Study burden and risks
For this study, we will not adapt current clinical practice. The time burden
for a measurement session is approx. 120 minutes. The investigators of the
department of Anesthesiology have ample experience with all described sensory
tests and cornea confocal microscopy. As described above, is the estimated risk
for the patient minimal.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
Patients with chronic migraine with medication overuse:
i) age between 18 and 75 years;
ii) able to provide written informed consent;
iii) diagnosed with chronic migraine and medication overuse according to ICHD
3-beta criteria. ,
Patients with chronic migraine without medication overuse:
i) age between 18 and 75 years;
ii) able to provide written informed consent;
iii) diagnosed with chronic migraine according to ICHD 3-beta criteria. ,
Patients with episodic migraine:
i) age between 18 and 75 years;
ii) able to provide written informed consent;
iii) diagnosed with migraine with or without aura according to ICHD 3-beta
criteria;
Exclusion criteria
Patients with chronic migraine with medication overuse:
i) Other primary or secondary headache syndromes except tension type headache
or medication overuse headache
Patients with chronic migraine without medication overuse:
i) Other primary or secondary headache syndromes except tension type headache
Patients with episodic migraine:
i) Other primary or secondary headache syndromes except tension type headache
(ii) A history of chronic migraine according to IHS 3-β criteria <1 year prior
to inclusion;
(iii) A history of medication overuse headache according to IHS 3-β criteria <1
year prior to inclusion.
General exclusion criteria:
(i) Neurological conditions, such as peripheral neuropathy or epilepsy, other
than the specific types described in the group specific inclusion criteria;
(ii) Any (chronic) pain condition of moderate to severe intensity, or requiring
pain medication, other than the types described in the group specific inclusion
criteria;
(iii) Psychiatric disease, such as psychosis, other than mild to moderate
depression and anxiety, which in the opinion of the investigators may interfere
with the study;
(iv) Other medical disease such as pulmonary renal, liver, cardiac,
gastro-intestinal, vascular disease, which in the opinion of the investigators
may interfere with the study;
(v) Regular use of non-triptan or non-analgesic acute anti-headache medication
(e.g. ergots, high dose opioids (low dosages or sporadic/temporary users are
allowed), barbiturates) or high dose benzodiazepines;
(vi) Change in use of TCAs (a.o. amitriptyline high dosages (>40 mg/daily),
clomipramine, dosulepin, doxepin, imipramine, nortriptyline, maprotiline),
SNRIs (a.o. high dose duloxetine / venlafaxine, trazodone), or calcium channel
inhibitors (a.o. pregabalin, gabapentin) in the past three months.
(vii) Current abuse or history of abuse of alcohol, soft drugs or hard drugs,
which in the opinion of the investigators may interfere with the study;
(viii) Pregnancy or lactation;
(ix) Enrolment in other studies that may confound the results of this study.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL60419.058.17 |
| OMON | NL-OMON24226 |