Professional Statements and Societal Positions Guidelines
Practice Guidelines and Position Statements
North American Spine Society
The North American Spine Society (NASS; 2015) published coverage recommendations for percutaneous sacroiliac joint (SIJ) fusion. NASS indicated that there was relatively moderate evidence. In the absence of high-level data, NASS policies reflect the multidisciplinary experience and expertise of the committee members in order to present reasonable standard practice indications in the United States. NASS recommended coverage when ALL of the following criteria are met:
1. "[Individuals] have undergone and failed a minimum 6 months of intensive nonoperative treatment that must include medication optimization, activity modification, bracing and active therapeutic exercise targeted at the lumbar spine, pelvis, SIJ and hip including a home exercise program.
2. Individual's report of typically unilateral pain that is caudal to the lumbar spine (L5 vertebra), localized over the posterior SIJ, and consistent with SIJ pain.
3. A thorough physical examination demonstrating localized tenderness with palpation over the sacral sulcus (Fortin's point, i.e., at the insertion of the long dorsal ligament inferior to the posterior superior iliac spine or PSIS) in the absence of tenderness of similar severity elsewhere (e.g., greater trochanter, lumbar spine, coccyx) and that other obvious sources for their pain do not exist.
4. Positive response to a cluster of 3 provocative tests (e.g., thigh thrust test, compression test, Gaenslen's test, distraction test, Patrick's sign, posterior provocation test). Note that the thrust test is not recommended in pregnant individuals or those with connective tissue disorders.
5. Absence of generalized pain behavior (e.g., somatoform disorder) or generalized pain disorders (e.g., fibromyalgia).
6. Diagnostic imaging studies that include ALL of the following:
a. Imaging (plain radiographs and a CT [computed tomography] or MRI [magnetic resonance imaging]) of the SI joint that excludes the presence of destructive lesions (e.g., tumor, infection) or inflammatory arthropathy that would not be properly addressed by percutaneous SIJ fusion.
b. Imaging of the pelvis (AP [anteroposterior] plain radiograph) to rule out concomitant hip pathology.
c. Imaging of the lumbar spine (CT or MRI) to rule out neural compression or other degenerative condition that can be causing low back or buttock pain.
d. Imaging of the SI joint that indicates evidence of injury and/or degeneration.
7. At least 75% reduction of pain for the expected duration of the anesthetic used following an image-guided, contrast-enhanced intra-articular SIJ injection on 2 separate occasions.
8. A trial of at least one therapeutic intra-articular SIJ injection (i.e., corticosteroid injection)."
American Society of Interventional Pain Physicians
The American Society of Interventional Pain Physicians (2013) guidelines have been updated. The updated guidelines recommend the use of controlled SIJ blocks with placebo or controlled comparative local anesthetic block when indications are satisfied with suspicion of SIJ pain. A positive response to a joint block is considered to be at least a 75% improvement in pain or in the ability to perform previously painful movements. For therapeutic interventions, the only effective modality with fair evidence was cooled radiofrequency neurotomy, when used after the appropriate diagnosis was confirmed by diagnostic SIJ injections.
American Society of Anesthesiologists et al
The American Society of Anesthesiologists and the American Society of Regional Anesthesia and Pain Medicine (2010) updated their joint guidelines for chronic pain management. The guidelines recommended that "Diagnostic sacroiliac joint injections or lateral branch blocks may be considered for the evaluation of individuals with suspected sacroiliac joint pain." Based on opinions of consultants and society members, the guidelines recommend that "Water-cooled radiofrequency ablation may be used for chronic sacroiliac joint pain."
American Pain Society
The practice guidelines from the American Pain Society (2009) were based on a systematic review commissioned by the Society. NA The guidelines stated that there was insufficient evidence to evaluate validity or utility of diagnostic SIJ block as a diagnostic procedure for low back pain with or without radiculopathy; the guidelines further stated that there was insufficient evidence to adequately evaluate benefits of SIJ steroid injection for nonradicular low back pain.
International Society for the Advancement of Spine Surgery
The International Society for the Advancement of Spine Surgery (2014) updated its policy statement on minimally invasive SIJ fusion in 2016. Society recommendations indicated that individuals who met all of the following criteria may be eligible for minimally invasive SIJ fusion:
- "Significant SI [sacroiliac] joint pain … or significantly limitations in activities of daily living because of pain from the SI joint(s).
- "SI joint pain confirmed with … at least 3 positive physical provocation examination maneuvers that stress the SI joint.
- "Confirmation of the SI joint as a pain generator with greater than or equal to 75% acute decrease in pain immediately following fluoroscopically guided diagnostic intra-articular SI joint block using local anesthetic.
- "Failure to respond to at least 6 months of non-surgical treatment consisting of non-steroidal anti-inflammatory drugs and/or … one or more of the following: … physical therapy…. Failure to respond means continued pain that interferes with activities of daily living and/or results in functional disability;
- "Additional or alternative diagnoses that could be responsible for the individual's ongoing pain or disability have been considered, investigated and ruled out."
National Institute for Health and Care Excellence
The National Institute for Health and Care Excellence (2017) guidance on minimally invasive SIJ fusion surgery for chronic sacroiliac pain included the following recommendations:
1.1 "Current evidence on the safety and efficacy of minimally invasive sacroiliac (SI) joint fusion surgery for chronic SI pain is adequate to support the use of this procedure….
1.2 Individuals having this procedure should have a confirmed diagnosis of unilateral or bilateral SI joint dysfunction due to degenerative sacroiliitis or SI joint disruption.
1.3 This technically challenging procedure should only be done by surgeons who regularly use image-guided surgery for implant placement. The surgeons should also have had specific training and expertise in minimally invasive SI joint fusion surgery for chronic SI pain."
Table 18. Summary of Key Trials
NCT No.
|
Trial Name
|
Planned Enrollment
|
Completion Date
|
Ongoing
|
|
|
|
NCT01861899a
|
Treatment of Sacroiliac Dysfunction With SI-LOK® Sacroiliac Joint Fixation System
|
55
|
Nov-18
|
NCT02270203a
|
LOIS: Long-Term Follow-Up in INSITE/SIFI
|
103
|
Dec-19
|
NCT02074761a
|
Evolusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System
|
250
|
Aug-20
|
NCT03230279a
|
Randomized Controlled Trial Of Minimally Invasive Sacroiliac Joint Fusion Compared To Radiofrequency Ablation For Sacroiliac Joint Dysfunction
|
84
|
Sep 2023 (withdrawn)
|
NCT: national clinical trial.
a Denotes industry-sponsored or cosponsored trial.