Chronic Lower Back Pain (CLBP) Clinical Trial
Official title:
Endoscopic Electrothermic Procedure of the Sacroiliac Joint
1. Determine the rate and incidence of peri-operative & post-operative adverse events
(complications, infections, re-operations, re-admissions) in the endoscopic approach for
the treatment of SIJ arthropathy and chronic lower back pain (CLBP).
2. Determine the Health-Related Quality of Life (HRQoL) using EQ-5D scale, VAS (Visual
Analog Scale) & ODI (Oswestry Disability Index), outcomes following the endoscopic
approach for the treatment of SIJ arthropathy and chronic lower back pain (CLBP) (pre-
to post-operative changes).
Chronic low back pain (CLBP) that lasts for more than six months is estimated to occur in
60-80% of the general population in their lifetime and is associated with substantial
healthcare costs. The sacroiliac joint (SIJ) complex is one of the major sources of CLBP,
accounting for around 10-33% of the total number of CLBP cases. The SIJ complex consists of
the joint capsule, synovia, various muscles and ligamentous structures overlying the join and
neuronal structures that innervate the SIJ. Current interventional and surgical treatment
options for SIJ complex mediated CLBP include intraarticular and periarticular injection of
the joint, SIJ fusion and radio frequency ablation (RFA) of the neuronal structures
innervating the SIJ. The described interventional procedures are simple procedures and
provides quick pain relief, but the effect is short-lived. In addition, SIJ fusion is an
invasive surgical procedure that should be reserved for refractory intractable pain of the
SIJ1.
New endoscopic electrothermic ablation of the SIJ capsula, synovial and neuronal structures
have been utilized in the treatment of facetogenic CLBP in a few number of clinical reports
with favorable results, but to our knowledge, the efficacy of this technique when applied to
SIJ-associated CLBP has not been reported. In this study, the investigators will utilize
endoscopy for the precise microsurgical and ablation (ESIJ) of the potential pain generators
associated with the SIJ and evaluate the clinical efficacy of this new technique.
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