The primary objective in this study is to compare the effectiveness of lateral C1-2 pulsed radiofrequency application (LPRF) in comparison with conventional C3-5 facet denervation (MBRF) in patients with clinically defined cervicogenic headache.
ID
Source
Brief title
Condition
- Joint disorders
- Headaches
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the proportion of patients that experience more
than 50% pain relief at 1 month after either procedure. Numerical rating scale
(NRS) scores for pain will be recored at baseline and at each follow-up visit.
Secondary objectives include the rescue rates (proportion of patients with less
than 50% pain relief requiring additional treatment).
Secondary outcome
The secondary outcomes in this study includes
1. The proportion of patients that require additional treatment 1 month after
the first procedure
2. The NRS (Numerical Rating Scale) scores at 1, 2 and 3 moth intervals using
the PGIC (Patient Global Impression of Change) .
3. Scores from 4 questionnaires
a. SF-36 (Quality of Life)
b. HIT-6 (Headache Impact)
c. NDI (Neck Disability Index)
d. MOS Sleep Scale (Medical Outcomes Study Sleep
Scale)
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.
The most extensively studied and widely accepted treatment for cervicogenic
headache is percutaneous radiofrequency neurotomy of the medial branches
(conventional C3-5 medial branch radiofrequency (MBRF) that supply the affected
cervical zygapophysial joints. Reported success rates in the literature for
this standard technique, which is our control group, range from 33% to 50% at
2-3 months.
Atlanto-axial joint (C1-2) injections have also identified the lateral
atlanto-axial joint as a source of pain in patients with cervicogenic headache.
In a retrospective study with 86 patients (Halim and Chua et al. Long Term Pain
Relief in patients with Cervicogenic Headaches after Pulsed Radiofrequency
Application into the Lateral Atlanto-Axial (C1-2) Joint using an Antero-lateral
Approach. Accepted in Pain Practice and awaiting publication), pulsed
radiofrequency (PRF) application into the lateral C1-2 joint of cervicogenic
headache patients produced long term pain relief. The proportion of patients
who had *50% pain relief at 2 months, 6 months and 1 year were 50% (43/86), 50%
(43/86) and 44.2% (38/86) respectively.
In a prospective trial, we aim to determine the effectiveness of lateral C1-2
joint PRF application (LPRF=study group) versus conventional C3-5 facet
denervation (MBRF=control group) in patients who have clinically defined
cervicogenic headache.
Study objective
The primary objective in this study is to compare the effectiveness of lateral
C1-2 pulsed radiofrequency application (LPRF) in comparison with conventional
C3-5 facet denervation (MBRF) in patients with clinically defined cervicogenic
headache.
Study design
The study is designed as a randomised single-blind clinical trial. Patients
aged 18 years and above with cervicogenic headache of at least 3 months
duration are eligible for inclusion. The patients will be given both oral and
written information about the procedures and baseline evaluation will only be
performed after informed consent is given. The diagnostic criteria from
Antonaci, which had been adapted from the original Sjastaad*s criteria will be
used to define possible and probable cervicogenic headache. Only patients with
at least possible cervicogenic headache will be included into the study. The
included patients will then be randomized into the 2 treatment groups. For both
treatment groups LPRF and MBRF, if there is significant pain relief after 1
month, the patient is followed up for another 2 months. If there is less than
50% pain relief at 1 month, the patient will undergo additional treatment and
is then followed up for another 2 months. The patients will be given
questionnaires (PGIC, SF-36, HIT-6, Neck Disability Index and MOS Sleep Scale)
at the end of the consult that require a maximum of 20 min to complete. The
inclusion period of the study is from June 2010 till June 2011. 70 patients
will be recruited and treated entirely at St Anna Hospital Outpatient Pain
Management Centre in Geldrop and will be followed up for a total of 3 months in
this study.
Intervention
In this RCT, the effectiveness of lateral C1/2 joint pulsed radiofrequency
application (LPRF) is compared to conventional C3-5 facet denervation (MBRF).
The 2 procedures differs in several aspects.
LPRF targets the lateral atlanto-axial joint (C1/2 joint) and is done with the
patient lying supine. Only one needle puncture is required (usually just below
the angle of the mandible) and the needle is directed under fluroscopic
guidance. No local anaesthetic is given into the joint due to possible
extravasation risks and side effects of ataxia. Pulsed radiofrequency
application does not create an actual thermal lesion but its effects are
believed to be a result of electrical fields generated at the needle tip and
hence has no or little risk of causing permanent neural damages.
MBRF is the conventional technique used to treat cervical facet joint pain and
is used in this case to treat cerrvicogenic headache which is a complication of
the primary facet joint pain. it is performed also with the patient supine but
requires 3 needle punctures at the lateral aspect of the neck. The needles are
directed fluroscopically to the facetal pillars from C3-5. Local anaesthetics
have to be given prior to the radiofrequency lesioning as radiofrequency
denervation creates an actual thermal lesion as a result of the temperature
generated during the 90 seconds of probe activation. The possibility of causing
long lasting neural damages are inherent but rare in the procedure. However,
this technique is considered standard treatment for neck pain around the world
as it is relatively safe if standard stimulation protocols are adhered to.
Complications are rare in both procedures. in 250 LPRFs performed in St Anna
Hospital, there has been only 1 case of a patient developing a sudden but
temporary worsening of her headache which lasted 1 day. In C3-5 facet
deneravtion (MBRF), complications are rare as stated in available literature.
The incidence of inadvertent intravascular penetration for medial branch blocks
at cervical spinal level was reported to be 3.9%, comparable with the incidence
at lumbar level (3.7%). Other potential complications of facet joint
interventions are related to needle placement; they include dural puncture,
spinal cord trauma, spinal anesthesia, neural trauma, radiation exposure, facet
capsule rupture and hematoma formation. After MBRF treatment, postoperative
burning pain is regularly reported. This pain disappears after 1 to 3 weeks.
Study burden and risks
The patient will take a maximum of 20 min to complete the 4 specified
questionnaires. Otherwise, the procedures performed are entirely consistent
with the routine treatment in St Anna Hospital, Geldrop.
Postbus 9101
6500 HB Nijmegen
Nederland
Postbus 9101
6500 HB Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
Male and female patients who are 18 years or more of age.
Patients with a history of chronic, function-limiting cervicogenic headache of at least 3 months duration.
Patients who are able to provide voluntary, written informed consent to participate in this evaluation.
Patients willing to return for follow-ups.
Patients without a history of recent surgical procedures (i.e. within the last 6 months)
Exclusion criteria
Patients with uncontrolled major depression or psychiatric disorders.
Patients with recent history of heavy opioid usage, chronic alcoholism or substance abuse.
Patients with acute or uncontrolled medical illness, malignancy or poorly controlled epilepsy.
Patients with chronic severe conditions that could interfere with the interpretations of the outcome assessments.
Patients with fibromylagia or painful syndromes of unknown origin or associated with diffuse pains.
Female patients who are pregnant or lactating,
Patients with histories of adverse reactions to local anesthetic or steroids
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 | NL30922.091.09 |