NCT01158092

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 8, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Last Updated

May 6, 2013

Status Verified

May 1, 2013

Enrollment Period

1.7 years

First QC Date

July 6, 2010

Last Update Submit

May 3, 2013

Conditions

Chronic Sacroiliac Joint Pain

Outcome Measures

Primary Outcomes (1)

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

    12 months

Secondary Outcomes (4)

  • 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

    12 months

  • Change in quality of life using the Assessment of Quality of Life (AQOL)

    12 months

Study Arms (2)

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

Treatment with SInergy™ SystemDEVICE

Lateral branch denervation using the SInergy™ System

Treatment with SInergy™ System
Conservative TreatmentOTHER

Treatment with physical therapy, chiropractic care, and medication

Conservative Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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).
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital Pain Trials Center

Chestnut Hill, Massachusetts, 02467, United States

Location

MeSH Terms

Interventions

TherapeuticsConservative Treatment

Study Officials

  • Edgar L Ross, M.D.

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2010

First Posted

July 8, 2010

Study Start

July 1, 2010

Primary Completion

March 1, 2012

Last Updated

May 6, 2013

Record last verified: 2013-05

Locations

US(1)