Trial Comparing Treatment With SInergy™ System to Conservative Treatment for Chronic Sacroiliac Joint Pain
NCT ID: NCT01158092
Last Updated: 2013-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
5 participants
INTERVENTIONAL
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment with SInergy™ System
Lateral branch denervation using the SInergy™ System
Treatment with SInergy™ System
Lateral branch denervation using the SInergy™ System
Conservative Treatment
Treatment with physical therapy, chiropractic care, and medication
Conservative Treatment
Treatment with physical therapy, chiropractic care, and medication
Interventions
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Treatment with SInergy™ System
Lateral branch denervation using the SInergy™ System
Conservative Treatment
Treatment with physical therapy, chiropractic care, and medication
Eligibility Criteria
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Inclusion Criteria
* \>75% pain relief from 2 separate lateral branch blocks done on different days (followed by return to baseline pain)
* Chronic axial pain lasting for longer than six months: 3 day average VAS between 4 and 8.
* Age greater than 18 years.
* Failed to achieve adequate improvement with comprehensive non-operative treatments, including but not limited to: activity alteration, non-steroidal anti-inflammatory, physical and/or manual therapy, and fluoroscopically guided steroid injections in and around the area of pathology.
* All other possible sources of low back pain have been ruled out, including but not limited to: the intervertebral discs, bone fracture, the zygapophyseal joints, the hip joint, symptomatic spondylolisthesis, tumor and other regional soft tissue structures (this is done by physical exam, medical history, and MRI/CT/X-ray as required)
Exclusion Criteria
* Spinal pathology that may impede recovery such as spina bifida occulta, spondylolisthesis at L5/S1, or scoliosis.
* Moderate or severe foraminal or central canal stenosis
* Systemic infection or localized infection at anticipated introducer entry site.
* Concomitant cervical or thoracic pain greater than 2/10 on a VAS
* Uncontrolled or acute illness
* Chronic severe conditions such as rheumatoid/inflammatory arthritis
* Pregnancy
* Active radicular pain
* Immunosuppression (eg. AIDS, cancer, diabetes, surgery \<3 months ago)
* Worker's compensation, injury litigation, or disability remuneration
* Allergy to injectants or medications used in procedure
* High narcotics use (\>30 mg hydrocodone or equivalent)
* Patients who smoke. Termination for at least 6 months and no smoking during follow up period are acceptable with caution.
* Body Mass Index greater than 29.9 (obese).
* Subject unwilling to consent to the study
18 Years
ALL
No
Sponsors
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Baylis Medical Company
INDUSTRY
Responsible Party
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Principal Investigators
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Edgar L Ross, M.D.
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Brigham and Women's Hospital Pain Trials Center
Chestnut Hill, Massachusetts, United States
Countries
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Other Identifiers
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BMC-SI-CIP-002
Identifier Type: -
Identifier Source: org_study_id
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