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

NCT00802997 | Completed Results

• 1 other identifier: SInergy
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Other Acute Pain; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Pain Status Change for Sacroiliac Joint Pain Intensity

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

  Baseline and 3 months

Other Outcomes (2)

• Pain Status Change for Sacroiliac Joint Pain Intensity

  Baseline and 6 Months

• Pain Status Change for Sacroiliac Joint Pain Intensity

  Baseline and 9 Months

Study Arms (2)

1

ACTIVE COMPARATOR

Treatment with Sinergy system

Device: Sinergy

2

PLACEBO COMPARATOR

placebo controlled

Device: Placebo sham

Interventions

Sinergy DEVICE

radiofrequency denervation

1

Placebo sham DEVICE

sham procedure

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylis Medical Company: lead

Study Sites (1)

Coastal Orthopedics & Sports Medicine

Bradenton, Florida, 34209, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Meghal Khakhar, Director of Regulatory and Scientific Affairs
• Organization: Baylis Medical

mkhakhar@baylismedical.com

9056024875

Study Officials

• Nileshkumar Patel, MD

  Coastal Orthopedics & Sports Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2008
• First Posted: December 5, 2008
• Study Start: June 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: January 1, 2014
• Results First Posted: January 1, 2014

Record last verified: 2013-11

Locations

US (1)