Endoscopic Electrothermic Procedure of the Sacroiliac Joint
TerminatedNot applicableNCT03920345
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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).
Study details
- Official title
- Endoscopic Electrothermic Procedure of the Sacroiliac Joint
- Conditions
- Chronic Lower Back Pain (CLBP)
- SIJ Arthropathy
- Interventions
- Device: MultiZYTE
- Sponsor
- joimax, Inc.
- Collaborators
- MileStone Research Organization
- Start date
- 2018-06-08
- Primary completion
- 2019-05-16
- Sex
- All
- Age range
- from 18 Years to 85 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 3
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: Subject age 18 - 85 years; * SIJ arthropathy and chronic lower back pain (CLBP); * Patient to undergo endoscopic electrothermic ablation of spinal levels S1-S3. The L4-L5 and/or L5-S1 facet joint can be included in the ablation per doctor discretion. * Correct spinal levels (ranging L4-S3) to be treated have been confirmed by 1) diagnostic SIJ injection, followed by 2) diagnostic Medial/Lateral Branch Block at the applicable levels. * The subject is likely to follow standard of care post-operative follow-up for at least 24 months. Exclusion Criteria: Patients receiving additional invasive back surgery after the study treatment. * Inability to complete follow-up visits or required questionnaires. * Non-compliant patients * Difficult or impossible communication with the patient * Breastfeeding, pregnant or patients who plan a pregnancy while participating in the study * Systemic neurological disorders with mobility limitations (e.g. advanced Parkinson's disease or multiple sclerosis) * Patients with incompatibilities or known limitations that make participation impossible * Patients after stabilization with implants on thoracic or lumbar spine. * Inability to provide informed consent without a legally authorized representative.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03920345