Condition or disease | Intervention/treatment | Phase |
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Chronic Lower Back Pain (CLBP) SIJ Arthropathy | Device: MultiZYTE | Not Applicable |
Chronic low back pain (CLBP) that lasts for more than six months is estimated to occur in 60-80% of the general population in their lifetime and is associated with substantial healthcare costs. The sacroiliac joint (SIJ) complex is one of the major sources of CLBP, accounting for around 10-33% of the total number of CLBP cases. The SIJ complex consists of the joint capsule, synovia, various muscles and ligamentous structures overlying the join and neuronal structures that innervate the SIJ. Current interventional and surgical treatment options for SIJ complex mediated CLBP include intraarticular and periarticular injection of the joint, SIJ fusion and radio frequency ablation (RFA) of the neuronal structures innervating the SIJ. The described interventional procedures are simple procedures and provides quick pain relief, but the effect is short-lived. In addition, SIJ fusion is an invasive surgical procedure that should be reserved for refractory intractable pain of the SIJ1.
New endoscopic electrothermic ablation of the SIJ capsula, synovial and neuronal structures have been utilized in the treatment of facetogenic CLBP in a few number of clinical reports with favorable results, but to our knowledge, the efficacy of this technique when applied to SIJ-associated CLBP has not been reported. In this study, the investigators will utilize endoscopy for the precise microsurgical and ablation (ESIJ) of the potential pain generators associated with the SIJ and evaluate the clinical efficacy of this new technique.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 5 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | A prospective, non-randomized, multi-center study, case series, clinical observation study of minimally invasive surgery for the treatment of SIJ arthropathy and chronic lower back pain (CLBP). |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Endoscopic Electrothermic Procedure of the Sacroiliac Joint |
Actual Study Start Date : | June 8, 2018 |
Actual Primary Completion Date : | May 16, 2019 |
Actual Study Completion Date : | May 16, 2019 |
Arm | Intervention/treatment |
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Experimental: Treatment: Endoscopic ET on SI joint
New techniques have been developed and tested to expand the usefulness of minimally invasive spine surgery beyond disk herniation. This includes endoscopic electrothermic ablation which can be used to target SIJ-associated CLBP. A small retrospective study demonstrated significant improvements in Visual Analog Scale and Oswestry Disability Index from pre-operative levels in patients with CLBP associated with the SIJ for up to 21 months following the procedure. However, there has not yet been a prospective study to assess the efficacy of this procedure, and therefore, this is the aim of this study.
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Device: MultiZYTE
Subjects can be treated either unilateral or bilateral, depending on their condition and the recommended treatment by the surgeon. The decision is a clinical one and is not influenced by the decision of whether to be included in the study or the subsequent outcomes and QoL analysis.
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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)
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
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
Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Subject age 18 - 85 years;
Exclusion Criteria:
Patients receiving additional invasive back surgery after the study treatment.
United States, Arizona | |
Dr. Azmi Nasser | |
Mesa, Arizona, United States, 85206 | |
United States, Minnesota | |
Dr. Daniel Hanson | |
Maple Grove, Minnesota, United States, 55369 | |
Dr. Louis Saeger | |
Minneapolis, Minnesota, United States, 55407 |
Principal Investigator: | Hope Donovan | MileStone Research Organization |
Tracking Information | |||||
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First Submitted Date ICMJE | April 2, 2019 | ||||
First Posted Date ICMJE | April 18, 2019 | ||||
Last Update Posted Date | July 19, 2019 | ||||
Actual Study Start Date ICMJE | June 8, 2018 | ||||
Actual Primary Completion Date | May 16, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Endoscopic Electrothermic Procedure of the Sacroiliac Joint | ||||
Official Title ICMJE | Endoscopic Electrothermic Procedure of the Sacroiliac Joint | ||||
Brief Summary |
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Detailed Description |
Chronic low back pain (CLBP) that lasts for more than six months is estimated to occur in 60-80% of the general population in their lifetime and is associated with substantial healthcare costs. The sacroiliac joint (SIJ) complex is one of the major sources of CLBP, accounting for around 10-33% of the total number of CLBP cases. The SIJ complex consists of the joint capsule, synovia, various muscles and ligamentous structures overlying the join and neuronal structures that innervate the SIJ. Current interventional and surgical treatment options for SIJ complex mediated CLBP include intraarticular and periarticular injection of the joint, SIJ fusion and radio frequency ablation (RFA) of the neuronal structures innervating the SIJ. The described interventional procedures are simple procedures and provides quick pain relief, but the effect is short-lived. In addition, SIJ fusion is an invasive surgical procedure that should be reserved for refractory intractable pain of the SIJ1. New endoscopic electrothermic ablation of the SIJ capsula, synovial and neuronal structures have been utilized in the treatment of facetogenic CLBP in a few number of clinical reports with favorable results, but to our knowledge, the efficacy of this technique when applied to SIJ-associated CLBP has not been reported. In this study, the investigators will utilize endoscopy for the precise microsurgical and ablation (ESIJ) of the potential pain generators associated with the SIJ and evaluate the clinical efficacy of this new technique. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: A prospective, non-randomized, multi-center study, case series, clinical observation study of minimally invasive surgery for the treatment of SIJ arthropathy and chronic lower back pain (CLBP). Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Device: MultiZYTE
Subjects can be treated either unilateral or bilateral, depending on their condition and the recommended treatment by the surgeon. The decision is a clinical one and is not influenced by the decision of whether to be included in the study or the subsequent outcomes and QoL analysis.
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Study Arms ICMJE | Experimental: Treatment: Endoscopic ET on SI joint
New techniques have been developed and tested to expand the usefulness of minimally invasive spine surgery beyond disk herniation. This includes endoscopic electrothermic ablation which can be used to target SIJ-associated CLBP. A small retrospective study demonstrated significant improvements in Visual Analog Scale and Oswestry Disability Index from pre-operative levels in patients with CLBP associated with the SIJ for up to 21 months following the procedure. However, there has not yet been a prospective study to assess the efficacy of this procedure, and therefore, this is the aim of this study.
Intervention: Device: MultiZYTE
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Actual Enrollment ICMJE |
5 | ||||
Original Estimated Enrollment ICMJE |
100 | ||||
Actual Study Completion Date ICMJE | May 16, 2019 | ||||
Actual Primary Completion Date | May 16, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria: Subject age 18 - 85 years;
Exclusion Criteria: Patients receiving additional invasive back surgery after the study treatment.
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 85 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03920345 | ||||
Other Study ID Numbers ICMJE | MULTI-2018-05-31 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | joimax, Inc. | ||||
Study Sponsor ICMJE | joimax, Inc. | ||||
Collaborators ICMJE | MileStone Research Organization | ||||
Investigators ICMJE |
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PRS Account | joimax, Inc. | ||||
Verification Date | July 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |