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Completed

NCT Number: NCT00802997

Trial Assessing Cooled Radiofrequency Denervation as a Treatment for Sacroiliac Joint Pain Using the Sinergy System

to evaluate the effectiveness of cooled radiotherapy denervation of the sacroiliac region using the sinergy system by comparing a treatment group to a placebo group

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Key information

Conditions

Other Acute Pain Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Coastal Orthopedics & Sports Medicine

Bradenton, Florida, 34209, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Predominantly axial pain below L5 vertebrae
  • greater than 75%pain relief from 2 seperate lateral branch blocks done on different days
  • chronic axial pain lasting longer than 6 months, 3 day average VAS between 4 and 8
  • age greater than 18
  • failed to acheive adequate improvemnet with comprehensive non-operative treatments, includingbut not limited to: activity alteration, non0steriodal anti-iflammatory, physical and/or manual therap, and flurpscopically guided steriod injections in and around the area of pathology
  • all other possible sources oflow back pain have been ruled out, including but not limited to the intervertebral discs, bone fracture.

Exclusion criteria

  • Beck Depression greater than 20%
  • irreversible psychological barriers to recovery
  • spinal pathology that may impede recovery such as spins bifida occulta,
  • moderate to severe foraminal or central canal stenosis
  • systemic infection or localized infection at inducer site
  • concomitant cervical or thoracic pain greater than 2/10 on VAS
  • uncontrolled or acute disease
  • chronic severe condition such as rheumatoid arthritis
  • preganancy
  • active radicular pain
  • immunosuppression
  • workers compensation
  • allergy to injectants or medications used in procedure
  • high narcotis use greater than 30 mg hydrocodone or equivalent
  • smokers
  • body mass index greater than 29.9

Treatment and study plan

Sinergy

Device

radiofrequency denervation

Placebo sham

Device

sham procedure

Primary outcomes

  1. Pain Status Change for Sacroiliac Joint Pain Intensity

    Time frame: Baseline and 3 months

    Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain.

Other outcomes

  1. Pain Status Change for Sacroiliac Joint Pain Intensity

    Time frame: Baseline and 6 Months

    Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain.

  2. Pain Status Change for Sacroiliac Joint Pain Intensity

    Time frame: Baseline and 9 Months

    Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain.

Sponsors and collaborators

Lead sponsor

Baylis Medical Company

Industry

Registry information

Official study title

A Double Blind, Randomized, Controlled Trial Assessing Cooled Radiofrequency Denervation as a Treatment fr Sacroiliac Joint Pain Using the Sinergy System

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Dec 5, 2008
Registry last updated
Jan 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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