Trial Comparing Treatment With SInergy™ System to Conserv... | NCT01158092

Studies
Trial Comparing Treatment With SInergy™ System to Conservative Treatment for Chronic Sacroiliac Joint Pain

NCT01158092

Sponsor

Baylis Medical Company

Status

Terminated

Last Update Posted

May 6, 2013Estimated

Enrollment

5Actual

Phase

Not Applicable

Conditions

Chronic Sacroiliac Joint Pain

Interventions

Treatment with SInergy™ System
Conservative Treatment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Mar 2012Actual

Completion Date

Not provided

First Submitted Date

Jul 6, 2010

First Submission Date that Met QC Criteria

Jul 7, 2010

First Posted Date

Jul 8, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 3, 2013

Last Update Posted Date

May 6, 2013Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment with SInergy™ System	Active Comparator	Lateral branch denervation using the SInergy™ System	Device: Treatment with SInergy™ System
Conservative Treatment	Active Comparator	Treatment with physical therapy, chiropractic care, and medication	Other: Conservative Treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Treatment with SInergy™ System	Device	Lateral branch denervation using the SInergy™ System	Treatment with SInergy™ System

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain status change for sacroiliac region pain intensity assessed using visual analogue scale (VAS)		12 months

Secondary Outcomes

Measure	Description	Time Frame
Change in bodily pain evaluated using SF-36 Bodily Pain		12 months
Change in physical functioning evaluated using SF-36 Physical Function		12 months
Change in disability evaluated using Oswestry Disability Index 2.0

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Predominantly axial pain below the L5 vertebrae
>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:

Beck Depression Score >20 or irreversible psychological barriers to recovery
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D013812	Therapeutics
D000072700	Conservative Treatment