Endoscopic Electrothermic Procedure of the Sacroiliac Joint (ESIJ)

July 17, 2019 updated by: joimax, Inc.
  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 Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Dr. Azmi Nasser
    • Minnesota
      • Maple Grove, Minnesota, United States, 55369
        • Dr. Daniel Hanson
      • Minneapolis, Minnesota, United States, 55407
        • Dr. Louis Saeger

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in EQ-5D-3L
Time Frame: Pre-Op, Peri-Op, 6-weeks, 3-months, 6-months, 12-months, 24-months post-op

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
Change in Visual Analogue Scale (VAS)
Time Frame: Pre-Op, Peri-Op, 6-weeks, 3-months, 6-months, 12-months, 24-months post-op

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
Change in Oswestry Disability Index (ODI)
Time Frame: Pre-Op, Peri-Op, 6-weeks, 3-months, 6-months, 12-months, 24-months post-op

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

joimax, Inc.

Collaborators

MileStone Research Organization

Investigators

  • Principal Investigator: Hope Donovan, MileStone Research Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 8, 2018

Primary Completion (ACTUAL)

May 16, 2019

Study Completion (ACTUAL)

May 16, 2019

Study Registration Dates

First Submitted

April 2, 2019

First Submitted That Met QC Criteria

April 17, 2019

First Posted (ACTUAL)

April 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 19, 2019

Last Update Submitted That Met QC Criteria

July 17, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MULTI-2018-05-31

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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