Table 1.
Overview of clinical trials on sacroiliac joint pain interventions: comparative study design, outcomes, and results
| Study | Study type | Region | Clinical trial registration No. | Intervention | Control | Sponsor | Implant or device used | Follow-up time (mo) | Measured outcomes |
|---|---|---|---|---|---|---|---|---|---|
| Cohen et al., [25] (2008) | RCT | USA | NCT00373724 | Cooled RF | Placebo | Baylis Medical | Baylis RF System | 1, 2, 6 | Pain NRS, ODI, analgesic used, GPE |
| Patel et al., [29] (2012) | RCT | USA | NR | Cooled RF | Placebo | Baylis Medical | Baylis RF System | 1, 3, 6, 9 | Pain NRS, ODI, SF-36, AQoL, GPE |
| Zheng et al., [26] (2014) | RCT | China | ChiCTR-TRC-12002483 | Thermal RF | Medication | No | Baylis RF System | 3, 6 | Pain VAS, ASAS20, ASDAS, BASMI, BASFI, serum CRP |
| Whang et al., [24] (2015) | RCT | USA | NCT01681004 | SIJF | All types of NSM* | SI-BONE | Triangular Titanium Implant (iFuse) | 1, 3, 6 | Pain VAS, ODI, EQ-5D, SF-36, ambulatory or work status, analgesic used, physical examination |
| Canovas Martinez et al., [27] (2016) | RCT | Spain | NR | Thermal RF | SIJI | No | Cosman | 3 | Pain VAS |
| Van Tilburg et al., [28] (2016) | RCT | Netherlands | ISRCTN45914408 | Thermal RF | Placebo | No | Neurotherm | 1, 3 | Pain NRS, GPE |
| Dengler et al., [30] (2017) | RCT | USA | NCT01741025 | SIJF | CM† | SI-BONE | Triangular Titanium Implant (iFuse) | 1, 3, 6, 12 | Pain VAS, ODI, ASLR, EQ5D, Zung Depression Scale, Satisfaction Questionnaires, Walking Distance |
| Dutta et al., [31] (2018) | RCT | India | NR | Pulsed RF | SIJI | No | Baylis RF System | 0.5, 1, 3, 6 | Pain NRS, ODI, GPE |
| Mehta et al., [32] (2018) | RCT | UK | NCT01726608 | Cooled RF | Placebo | No | Neurotherm | 3, 6 | Pain NRS, SF-12, HADS, EQ-5D |
RCT, randomized controlled trial; SIJF, sacroiliac joint fusion; NSM, nonsurgical management; VAS, visual analogue scale; ODI, Oswestry Disability Index; EQ-5D, EuroQoL-5 dimension; SF-36, 36-item Short Form health survey; NRS, Numerical Rating Scale; GPE, Global Perceived Effect; ASAS20, Assessment of SpondyloArthritis International Society Response Criteria; ASDAS, Ankylosing Spondylitis Disease Activity Score; BASMI, Bath Ankylosing Spondylitis Metrology Index; BASFI, Bath Ankylosing Spondylitis Functional Index; RF, ____; CRP, C-reactive protein; NR, not related or not available; SIJI, sacroiliac joint injection; AQoL, Assessment of Quality of Life assessment tool; CM, conservative management; ASLR, Active Straight Leg Raise Test; HADS, Hospital and Depression Scale.
Nonsurgical management including all conservative management and radiofrequency ablation.
Conservative management including medical therapy, physiotherapy, and stabilization exercises.