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TerminatedNCT01158092SI-RCT-RossUpdated May 6, 2013

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

An interventional study of Treatment with SInergy™ System and Conservative Treatment in Chronic Sacroiliac Joint Pain, sponsored by Baylis Medical Company. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-06.

Sponsored by Baylis Medical Company · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Sacroiliac Joint Pain

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03

In context

Arthralgia

273 studies on the registry are indexed under Arthralgia; 41 are open to participants now.

This study's enrollment of 5 is below the median of 63 across 219 interventional studies indexed under Arthralgia.

Browse Arthralgia studies →

Lead sponsor

Baylis Medical Company is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Active comparator
    Treatment with SInergy™ System

    Lateral branch denervation using the SInergy™ System

    Device: Treatment with SInergy™ System

  • Active comparator
    Conservative Treatment

    Treatment with physical therapy, chiropractic care, and medication

    Other: Conservative Treatment

Interventions

  • DeviceTreatment with SInergy™ System

    Lateral branch denervation using the SInergy™ System

  • OtherConservative Treatment

    Treatment with physical therapy, chiropractic care, and medication

06

What researchers measure

Primary outcomes

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

    Time frame: 12 months

Secondary outcomes

  1. Change in bodily pain evaluated using SF-36 Bodily Pain

    Time frame: 12 months

  2. Change in physical functioning evaluated using SF-36 Physical Function

    Time frame: 12 months

  3. Change in disability evaluated using Oswestry Disability Index 2.0

    Time frame: 12 months

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

    Time frame: 12 months

07

Study locations

1 site
  • Brigham and Women's Hospital Pain Trials Center
    Chestnut Hill, Massachusetts 02467, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01158092
Lead sponsor
Baylis Medical Company
Responsible party
Sponsor
First posted
Jul 8, 2010
Start date
Jul 2010
Primary completion
Mar 2012
Last update
May 6, 2013

Study contacts

Edgar L Ross, M.D.
principal investigator · Brigham and Women's Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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