The primary objective in this study is to evaluate effectiveness of optimized high cervical epidural neurostimulation against placebo-stimulation in patients with intractable cervicogenic headache in a neurostimulation trial.
ID
Source
Brief title
Condition
- Joint disorders
- Headaches
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the mean daily VAS (visual analogue scale) pain
scores during the 4 days of test-stimulation versus the 4 days of
placebo-stimulation. Objective parameters in the form of QST measurements will
also be obtained.
Secondary outcome
Secondary parameters includes:
1. QST measurements over:
a. Thenar eminence on the hand
b. Suboccipital area (2 cm inferior and lateral to the occipital protuberance)
c. V2-3 dermatome (over the masseter muscle)
2. Qualitiy of Life using the SF-12 which will be applied at baseline
assessment and at the last consult after the trial.
Background summary
Cervicogenic headache is pain referred to the head from a source in the
cervical spine. The prevalence of cervicogenic headache has been estimated up
to 4•1% in the general population and as high as 17•5% among patients with
severe headaches. The prevalence is as high as 53% in patients with headache
after whiplash. Currently, no drugs are effective for cervicogenic headache.
For some patients with cervicogenic headaches, the current available treatments
such as cervical facet denervation, greater occipital nerve blocks, anterior
cervical vertebral fusion, greater occipital nerve stimulation have limited
success both in terms of efficacy and duration of action. Incorporating the
definition of Goadsby and colleagues, we define these group of patients as
having *Intractable cervicogenic headache*. The convergence of the cervical and
trigeminal afferents in the trigeminocervical nucleus allows the bidirectional
transmission of pain signals between the neck and the trigeminal sensory
receptive fields of the face and head. For these patients, it is this
transmission junction that we should concentrate the efforts of our treatment.
High cervical epidural neurostimulation has been performed for more than 10
years for a variety of indications. Safety and technical aspects of the
procedure has been well reported in previous instances of cervical epidural
stimulation for severe Raynaud*s disease, failed neck surgery syndrome and in
patients with head and neck tumors.
Study objective
The primary objective in this study is to evaluate effectiveness of optimized
high cervical epidural neurostimulation against placebo-stimulation in patients
with intractable cervicogenic headache in a neurostimulation trial.
Study design
The study is designed as a randomized placebo-controlled double-blind clinical
trial. Patients aged 18 years and above with intractable cervicogenic headache
of at least 12 months duration are screened psychologically and degree of
disability assessed. The trial period begins with an optimization phase of 5
days to obtain each patient*s optimal neurostimulation settings. This is
followed by a stimulation-off interval and then proceeding on to a randomized
crossover phase, with each patient acting as his own control. The trial for
each patient concludes after the last QST (at the end of the 2nd stimulation
block).
Intervention
High Cervical Epidural Neurostimulation
We describe the standard approach to cervical epidural lead insertion. After
local anaesthesia with Lignocaine 1%, the epidural space will be reached with a
14-G Touhy needle at the level Thoracic 2/3 via a inter-laminar approach. Loss
of resistance to saline (NaCl 0.9%) indicates epidural placement of the Touhy
needle-tip. Fluoroscopic imaging will be performed in two planes (Lateral and
antero-posterior). A 33-cm octapolar electrode with 30 mm electrode distance, 6
mm electrode spacing and 1.3 mm diameter will be used. The electrode will be
directed cranially and slowly pushed to the upper cervical region of C2. The
final position will often be obstructed by the inferior margin of the occipital
bone (See Figure 2). Test stimulation will be performed in the operation room,
but that is by no means the end-point of our optimization process. In our
experience, pain relief and paraesthesia covering the whole painful region in
the neck, the occipital, and even the fronto-parietal regions can sometimes be
achieved immediately. But our hypothesis is that effect of neurostimulation on
the trigeminal nucleus caudalis will occur over days and therefore the
rationale for an optimization period of 5 days duration. Initial stimulation
settings will range from: amplitude 1.0-2.0V, frequency 100-200 Hz, impulse
duration 200-400 ms.
Study burden and risks
The patient will take a maximum of 20 min to complete the 4 specified
questionnaires mailed to him prior to his appointment. Each patient has to
undergo 3 QST measurements and each session takes 60 min to complete.
Postbus 9101
6500 HB Nijmegen
Nederland
Postbus 9101
6500 HB Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
1. Male and female patients who are 18 years or more of age.
2. Patients with a history of chronic, function-limiting cervicogenic headache of at least 12 months duration.
3. Patients who are able to provide voluntary, written informed consent to participate in this evaluation.
4. Patients willing to return for follow-ups.
5. Patients without a history of recent surgical procedures (i.e. within the last 6 months)
Exclusion criteria
1. Patients with uncontrolled major depression or psychiatric disorders.
2. Patients with recent history of heavy opioid usage, chronic alcoholism or substance abuse.
3. Patients with acute or uncontrolled medical illness, malignancy or poorly controlled epilepsy.
4. Patients with chronic severe conditions that could interfere with the interpretations of the outcome assessments.
5. Patients with fibromylagia or painful syndromes of unknown origin or associated with diffuse pains.
6. Female patients who are pregnant or lactating,
7. Patients with histories of adverse reactions to local anesthetic
8. Patients with anatomical abnormalities on cervical spine X-ray that may result in technical difficulties for blocks
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 | NL31135.091.10 |