An interventional study of Sacral lateral branch radiofrequency ablation under ultrasound guidance and Sacral lateral branch radiofrequency ablation under fluoroscopy guidance in Sacroiliac Joint Arthritis and Back Pain, sponsored by Diskapi Teaching and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-07.
Sponsored by Diskapi Teaching and Research Hospital · Not applicable, Interventional, and Treatment
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.
42 studies on the registry are indexed under Sacroiliitis; 11 are open to participants now.
This study's enrollment of 60 is above the median of 48 across 28 interventional studies indexed under Sacroiliitis.
Browse Sacroiliitis studies →Diskapi Teaching and Research Hospital is the lead sponsor of 106 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Low back pain due to sacroiliac joint dysfunction >6 months with a score ≥ 4 on a numeric rating scale.
Exclusion Criteria: The exclusion criteria were;
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in this group will receive sacral lateral branch radiofrequency ablation under ultrasound guidance.
Procedure: Sacral lateral branch radiofrequency ablation under ultrasound guidance
Patients in this group will receive sacral lateral branch radiofrequency ablation under fluoroscopy guidance.
Procedure: Sacral lateral branch radiofrequency ablation under fluoroscopy guidance
Sacral lateral branch radiofrequency ablation will be performed under ultrasound guided approach.
Sacral lateral branch radiofrequency ablation will be performed under fluoroscopy guided approach.
Change in pain numerical rating score from baseline
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'
Time frame: 3 months
Performance time
Radiofrequency ablation performance time will be recorded from the time the first image is obtained, until the procedure is completed
Time frame: During the procedure
Patient satisfaction
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).
Time frame: At 3 months
Pain medication use
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
Time frame: At 3 months
Success rate
Proportions of reporting \>50% pain relief.
Time frame: At 3 months
Functional disability
Change in Oswestry Disabilit Index ( Scale 0-100). 0 point is equated with no disability and 100 point is maximum disability possible
Time frame: At 1 and 3 months
Quality of life ( SF-36)
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;
Time frame: At 1 and 3 months
The number of needle passess
The number of attempts during the performance will be analysed.
Time frame: During the procedure
Plan to share: No — Findings of this study will be available from the principle investigator upon reasonable request.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Diskapi Teaching and Research Hospital →