1.) To determine the diagnostic value of a intra-articular injection with local anesthetics in the SIJ followed by RF SIJ denervation.2.) To determine the diagnostic value of a set of 5 SI provocation tests at examination, of with at least 3 areā¦
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
pain reduction
Secondary outcome
increase of daily activities.
Background summary
Chronic low back pain (CLBP) is a frequently occurring disease with major
impact for patients and society. De life-time prevalence of low back pain is
70-80%. In recent years there is increasing evidence that the sacroiliac joint
(SIJ) is (in part) a source in a subgroup of of CLBP patients. The prevalence
of SI joint pain in patients with CLBP is estimated 13-30%. The diagnosis *SIJ
related pain* is difficult to establish.
The gold standard for diagnosing SI joint related pain in patients with CLBP is
the intra-articular injection with local anesthetic. If positive a
radiofrequency denervation procedure of the SI joint will be done. Recently, 2
studies showed a good correlation between the intra-articular injection and a
multitest regime of SI provocation tests.
For the treatment of SI related pain minimal invasive techniques, like
radiofrequency (RF) denervation, are used. Usually, prior to RF procedures, a
diagnostic intra-articular injection with local anesthetics (diagnostic block)
is performed. If pain reduction is adequate the RF procedure will be performed.
Problem is that the additive value of this diagnostic block is never proved. It
is likely that the diagnostic blocks are superfluous.
Study objective
1.) To determine the diagnostic value of a intra-articular injection with local
anesthetics in the SIJ followed by RF SIJ denervation.
2.) To determine the diagnostic value of a set of 5 SI provocation tests at
examination, of with at least 3 are positive, followed by RF SIJ denervation.
Study design
We select patients with CLBP and pain over the SI joint, over the so called
Fortin area. Selection takes palce on basis of the interview and on the
physical examination. After inclusion and informed consent the patients will be
scheduled for an intra-articular injection in the SIJ and for a RF SIJ
denervation at the operation room of the Gelre hospital Apeldoorn. The
treatments are standard procedures for patients with CLBP.
The patients will receive a diagnostic block with a short acting local
anesthetic and ,on another day, a confirmatory block with a long acting local
anesthetic. The amount and duration of pain reduction are registered. Next, a
RF SIJ denervation will be performed. The injection and the RF SIJ denervation
are performed by different anesthsiologists.
In advance of the diagnostic block the patient is examined by a manual
therapist wit set of 5 SI provocation tests. All patients are asked to answer
some questionnaires (Oswestry, Roland Morris, SF 36) for determine the impact
of their pain on their daily activities. After the RF SIJ denervation there is
a follow up for 1 year. During the follow up the study data are collected by an
research assistant.
After 6 month additive treatments will be started if necessary.
This study will be executed in the outpatient clinic and operating theater of
the department of anesthesiology and pain management of the Gelre Ziekenhuizen
location Juliana.
Intervention
Injections in the sacro-iliac joint
Radiofrequency denervation of the sacro-ilac joint
Study burden and risks
Compared to the normal procedures, in this study patients have to fill in
several questionnaires, the physical examination will be repeated and patients
can be treated with a RF SI procedure regardless the results of the diagnostic
tests. There is considerably experience with these procedures and the risks are
negligible.
Postbus 9014
7300DS Apeldoorn
Nederland
Postbus 9014
7300DS Apeldoorn
Nederland
Listed location countries
Age
Inclusion criteria
patients with chronic low back pain, with pain over the SI area.
Exclusion criteria
Severe liver- and/or renal function disorders
Zwangerschap
Radicular pain in the leg with paresis
Diseases of the hip (painful coxartrosis; total hip prothesis)
Tumors in pelvis.
obstipation
incontinence
prolaps
hypertonic pelic musculature
Waddell score > 3 uit 5.
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 | NL13164.041.06 |