Other Acute PainNCT00802997
Trial Assessing Cooled Radiofrequency Denervation as a Treatment for Sacroiliac Joint Pain Using the Sinergy System
A study testing Sinergy in people with Other Acute Pain and Chronic Pain, run by Baylis Medical Company at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Other Acute Pain, Chronic Pain
- What is being tested?
- Sinergy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Aug 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Coastal Orthopedics & Sports Medicine
Bradenton, Florida, 34209
About this study
Official title: A Double Blind, Randomized, Controlled Trial Assessing Cooled Radiofrequency Denervation as a Treatment fr 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
- Conditions
- Other Acute Pain, Chronic Pain
- Being tested
- Sinergy, Placebo sham
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SinergyDevice
radiofrequency denervation
Placebo shamDevice
sham procedure
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Treatment with Sinergy system Receives: Device: Sinergy |
| 2 | Placebo comparator | placebo controlled Receives: Device: Placebo sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startJun 2008
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Other Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylis Medical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nileshkumar Patel, MD, Principal investigator, Coastal Orthopedics & Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802997
- Sponsor's protocol ID
- SInergy
- Status last verified
- Nov 2013
- First submitted
- 4 Dec 2008
- Last updated
- 1 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Controlled Trial Assessing Cooled Radiofrequency Denervation as a Treatment fr Sacroiliac Joint Pain Using the Sinergy System
- ClinicalTrials.gov ID
- NCT00802997
- Acronym / sponsor ID
- SInergy
- Conditions
- Other Acute Pain, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Baylis Medical CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 5 Dec 2008 (estimated)
- Results
- Posted 1 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: SinergyTreatment with Sinergy system |
| 2 | Placebo comparator | Device: Placebo shamplacebo controlled |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sinergyradiofrequency denervation | Device | 1 |
| Placebo shamsham procedure | Device | 2 |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nileshkumar Patel, MD principal investigator
Coastal Orthopedics & Sports Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sinergy in people with Other Acute Pain and Chronic Pain, run by Baylis Medical Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Status Change for Sacroiliac Joint Pain Intensity (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2014.