Clinical trial NCT01158092: Trial Comparing Treatment With SInergy™ System to Conservative Treatment for Chronic Sacroiliac Joint Pain
Official title: A Randomized Controlled Trial Comparing Cooled Radiofrequency Denervation to Conservative Treatment as a Treatment for Sacroiliac Joint Pain Using the SInergy™ System
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Sacroiliac Joint Pain
Lead sponsor: Baylis Medical Company
Sponsor class: INDUSTRY
First posted: 2010-07-08
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Pain status change for sacroiliac region pain intensity assessed using visual analogue scale (VAS)
timeFrame: 12 months
Secondary outcomes:
measure: Change in bodily pain evaluated using SF-36 Bodily Pain
timeFrame: 12 months
measure: Change in physical functioning evaluated using SF-36 Physical Function
timeFrame: 12 months
measure: Change in disability evaluated using Oswestry Disability Index 2.0
timeFrame: 12 months
measure: Change in quality of life using the Assessment of Quality of Life (AQOL)
timeFrame: 12 months
Other outcomes:
Locations:
city: Chestnut Hill
country: United States
facility: Brigham and Women's Hospital Pain Trials Center
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Edgar L Ross, M.D.
role: PRINCIPAL_INVESTIGATOR
References: