search
Back to results

Trial Comparing Treatment With SInergy™ System to Conservative Treatment for Chronic Sacroiliac Joint Pain (SI-RCT-Ross)

Primary Purpose

Chronic Sacroiliac Joint Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment with SInergy™ System
Conservative Treatment
Sponsored by
Baylis Medical Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Sacroiliac Joint Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's Hospital Pain Trials Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Treatment with SInergy™ System

Conservative Treatment

Arm Description

Lateral branch denervation using the SInergy™ System

Treatment with physical therapy, chiropractic care, and medication

Outcomes

Primary Outcome Measures

Pain status change for sacroiliac region pain intensity assessed using visual analogue scale (VAS)

Secondary Outcome Measures

Change in bodily pain evaluated using SF-36 Bodily Pain
Change in physical functioning evaluated using SF-36 Physical Function
Change in disability evaluated using Oswestry Disability Index 2.0
Change in quality of life using the Assessment of Quality of Life (AQOL)

Full Information

First Posted
July 6, 2010
Last Updated
May 3, 2013
Sponsor
Baylis Medical Company
search

1. Study Identification

Unique Protocol Identification Number
NCT01158092
Brief Title
Trial Comparing Treatment With SInergy™ System to Conservative Treatment for Chronic Sacroiliac Joint Pain
Acronym
SI-RCT-Ross
Official Title
A Randomized Controlled Trial Comparing Cooled Radiofrequency Denervation to Conservative Treatment as a Treatment for Sacroiliac Joint Pain Using the SInergy™ System
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Terminated
Study Start Date
July 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylis Medical Company

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effectiveness of cooled radiofrequency denervation of the sacroiliac region using the SInergy System compared to conservative treatment in the treatment of sacroiliac joint pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sacroiliac Joint Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment with SInergy™ System
Arm Type
Active Comparator
Arm Description
Lateral branch denervation using the SInergy™ System
Arm Title
Conservative Treatment
Arm Type
Active Comparator
Arm Description
Treatment with physical therapy, chiropractic care, and medication
Intervention Type
Device
Intervention Name(s)
Treatment with SInergy™ System
Intervention Description
Lateral branch denervation using the SInergy™ System
Intervention Type
Other
Intervention Name(s)
Conservative Treatment
Intervention Description
Treatment with physical therapy, chiropractic care, and medication
Primary Outcome Measure Information:
Title
Pain status change for sacroiliac region pain intensity assessed using visual analogue scale (VAS)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in bodily pain evaluated using SF-36 Bodily Pain
Time Frame
12 months
Title
Change in physical functioning evaluated using SF-36 Physical Function
Time Frame
12 months
Title
Change in disability evaluated using Oswestry Disability Index 2.0
Time Frame
12 months
Title
Change in quality of life using the Assessment of Quality of Life (AQOL)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edgar L Ross, M.D.
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital Pain Trials Center
City
Chestnut Hill
State/Province
Massachusetts
ZIP/Postal Code
02467
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs