Chronic Lower Back Pain (CLBP) Clinical Trial
— ESIJOfficial title:
Endoscopic Electrothermic Procedure of the Sacroiliac Joint
| Verified date | July 2019 |
| Source | joimax, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Terminated |
| Enrollment | 5 |
| Est. completion date | May 16, 2019 |
| Est. primary completion date | May 16, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Dr. Daniel Hanson | Maple Grove | Minnesota |
| United States | Dr. Azmi Nasser | Mesa | Arizona |
| United States | Dr. Louis Saeger | Minneapolis | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| joimax, Inc. | MileStone Research Organization |
United States,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in EQ-5D-3L | 5 Question Health Questionnaire: patient's rate their mobility, self-care, usual activities, pain/discomfort and anxiety/depression developed by Euroqol Research Foundation. Each of the 5 dimensions comprising the EQ-5D descriptive system is divided into 5 levels of perceived problems: Dimension 1: Mobility Dimension 2: Self-Care Dimension 3: Usual Activities Dimension 4: Pain/Discomfort Dimension 5: Anxiety/Depression Level 1: indicating no problem Level 2: indicating slight problems Level 3: indicating moderate problems Level 4: indicating severe problems Level 5: indicating extreme problems A total of 3,125 possible health states is defined in this way. Each state is referred to in terms of a 5 digit code. Lowest Score: 11111 (No problems on any of the 5 dimensions) Highest Score: 55555 (Extreme problems on all of the 5 dimensions) |
Pre-Op, Peri-Op, 6-weeks, 3-months, 6-months, 12-months, 24-months post-op | |
| Primary | Change in Visual Analogue Scale (VAS) | Health Questionnaire: patient's rate their health state on a scale from 0 to 100. Score Range: 0-100mm Low Score = Lower Pain Intensity High Score = Greater Pain Intensity |
Pre-Op, Peri-Op, 6-weeks, 3-months, 6-months, 12-months, 24-months post-op | |
| Primary | Change in Oswestry Disability Index (ODI) | 10 Question Health Questionnaire where patient's rate their level of back pain. Score Range: 0-100% Low Score = Minimal Disability High Score = Severe Disability |
Pre-Op, Peri-Op, 6-weeks, 3-months, 6-months, 12-months, 24-months post-op |