Back Pain, Sacroiliac Joint Arthritis
Conditions
Brief summary
Sacroiliac joint is a diarthroidal and synovial joint that receives sensory innervatin by the sacral lateral branches ( commonly S1-3, with variable contributions from L5 dorsal ramus and S4 lateral branch). Sacral lateral branch radiofrequency ablation and block techniques are widely used for the management of sacroiliac joint pain. With the increasing use of ultrasound technology in pain medicine, the ultrasound guided approaches gained popularity. To our knowledge, there are no randomized controlled trials comparing the ultrasound and fluoroscopy approaches for sacral lateral branch radiofrequency ablation. This study aims to compare the ultrasound and fluoroscopy guidance techniques for sacral lateral branch radiofrequency ablation.
Interventions
PROCEDURESacral lateral branch radiofrequency ablation under ultrasound guidance
Sacral lateral branch radiofrequency ablation will be performed under ultrasound guided approach.
PROCEDURESacral lateral branch radiofrequency ablation under fluoroscopy guidance
Sacral lateral branch radiofrequency ablation will be performed under fluoroscopy guided approach.
Sponsors
Diskapi Teaching and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Low back pain due to sacroiliac joint dysfunction \>6 months with a score ≥ 4 on a numeric rating scale. * 50% pain relief after prognostic sacral lateral branch block * At least 3 positive physical examination maneuvers \[ Faber ( flexioni abduction and external rotation), POSH (posteripr shear), REAB ( resisted abduction), Gaenslen's test, Distraction test\] * Refractory to conservative therapy
Exclusion criteria
The
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain numerical rating score from baseline | 3 months | The numerical rating score (NRS) will be used to assess the severity of pain felt by a patient. . The patient rates pain on a scale of 0 to 10; 0 represents 'no pain' and 10 ,represents 'worst pain imaginable' |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain medication use | At 3 months | Mean change in analgesic consumption is assessed using QAQ, a tool designed to record patient-reported pain medication use. The higher score indicates higher pain medication use |
| Success rate | At 3 months | Proportions of reporting \>50% pain relief. |
| Functional disability | At 1 and 3 months | Change in Oswestry Disabilit Index ( Scale 0-100). 0 point is equated with no disability and 100 point is maximum disability possible |
| Patient satisfaction | At 3 months | Changes in overall satisfaction will be assessed using a 5-point Likert scale. (1, very dissatisfied; 2, dissatisfied; 3, neutral; 4, satisfied; 5, very satisfied). |
| The number of needle passess | During the procedure | The number of attempts during the performance will be analysed. |
| Performance time | During the procedure | Radiofrequency ablation performance time will be recorded from the time the first image is obtained, until the procedure is completed |
| Quality of life ( SF-36) | At 1 and 3 months | Quality of life (QoL) will assessed via SF-36, which consists of 36 items ad 2 summary values for Physical Component Summary ( PSC) and Mental Component Summary (MSC). Subscale scores range from 0 to 100, with 100 being the most positive QoL in that area and 0 the lowest; |
Countries
Turkey (Türkiye)
Outcome results
None listed