Chronic Sacroiliac Joint PainSI-RCT-RossNCT01158092
Trial Comparing Treatment With SInergy™ System to Conservative Treatment for Chronic Sacroiliac Joint Pain
A study testing Treatment with SInergy™ System and Conservative Treatment in people with Chronic Sacroiliac Joint Pain, run by Baylis Medical Company at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Sacroiliac Joint Pain
- What is being tested?
- Treatment with SInergy™ System and Conservative Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital Pain Trials Center
Chestnut Hill, Massachusetts, 02467
About this study
Official title: A Randomized Controlled Trial Comparing Cooled Radiofrequency Denervation to Conservative Treatment as a Treatment for Sacroiliac Joint Pain Using the SInergy™ System
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.
- Conditions
- Chronic Sacroiliac Joint Pain
- Being tested
- Treatment with SInergy™ System, Conservative Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with SInergy™ SystemDevice
Lateral branch denervation using the SInergy™ System
Conservative TreatmentOther
Treatment with physical therapy, chiropractic care, and medication
| Study group | Role | What they receive |
|---|---|---|
| Treatment with SInergy™ System | Active comparator | Lateral branch denervation using the SInergy™ System Receives: Device: Treatment with SInergy™ System |
| Conservative Treatment | Active comparator | Treatment with physical therapy, chiropractic care, and medication Receives: Other: Conservative Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain status change for sacroiliac region pain intensity assessed using visual analogue scale (VAS)
Measured: 12 months
Secondary outcomes (4)
Change in bodily pain evaluated using SF-36 Bodily Pain
Measured: 12 months
Change in physical functioning evaluated using SF-36 Physical Function
Measured: 12 months
Change in disability evaluated using Oswestry Disability Index 2.0
Measured: 12 months
Change in quality of life using the Assessment of Quality of Life (AQOL)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Sacroiliac Joint 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
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylis Medical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edgar L Ross, M.D., Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158092
- Sponsor's protocol ID
- BMC-SI-CIP-002
- Acronym
- SI-RCT-Ross
- Status last verified
- May 2013
- First submitted
- 6 Jul 2010
- Last updated
- 6 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Cooled Radiofrequency Denervation to Conservative Treatment as a Treatment for Sacroiliac Joint Pain Using the SInergy™ System
- ClinicalTrials.gov ID
- NCT01158092
- Acronym / sponsor ID
- SI-RCT-Ross / BMC-SI-CIP-002
- Conditions
- Chronic Sacroiliac Joint Pain
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Baylis Medical CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Mar 2012 (actual)
- First posted
- 8 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with SInergy™ System | Active comparator | Device: Treatment with SInergy™ SystemLateral branch denervation using the SInergy™ System |
| Conservative Treatment | Active comparator | Other: Conservative TreatmentTreatment with physical therapy, chiropractic care, and medication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
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 |
|---|---|---|
| Treatment with SInergy™ SystemLateral branch denervation using the SInergy™ System | Device | Treatment with SInergy™ System |
| Conservative TreatmentTreatment with physical therapy, chiropractic care, and medication | Other | Conservative Treatment |
Primary outcome
Pain status change for sacroiliac region pain intensity assessed using visual analogue scale (VAS)
Time frame: 12 months
4 secondary outcomes
Change in bodily pain evaluated using SF-36 Bodily Pain
Time frame: 12 months
Change in physical functioning evaluated using SF-36 Physical Function
Time frame: 12 months
Change in disability evaluated using Oswestry Disability Index 2.0
Time frame: 12 months
Change in quality of life using the Assessment of Quality of Life (AQOL)
Time frame: 12 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2013.
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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.
Edgar L Ross, M.D. principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with SInergy™ System and Conservative Treatment in people with Chronic Sacroiliac Joint 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: stopped early, as of the sponsor's last update on 6 May 2013. 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. 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?
The study was stopped early. Results are not available in the source record.
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 region pain intensity assessed using visual analogue scale (VAS) (time frame: 12 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 6 May 2013.