Chronic Pain, Other Acute Pain
Conditions
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
Interventions
DEVICESinergy
radiofrequency denervation
DEVICEPlacebo sham
sham procedure
Sponsors
Baylis Medical Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Status Change for Sacroiliac Joint Pain Intensity | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain Status Change for Sacroiliac Joint Pain Intensity | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lateral Branch Neurotomy | 34 |
| Sham Procedure | 17 |
| Total | 51 |
Baseline characteristics
| Characteristic | Sham Procedure | Total | Lateral Branch Neurotomy |
|---|---|---|---|
| Age Continuous | 64 years STANDARD_DEVIATION 14 | 59 years STANDARD_DEVIATION 15 | 56 years STANDARD_DEVIATION 15 |
| Region of Enrollment United States | 17 participants | 51 participants | 34 participants |
| Sacroiliac Joint Pain Intensity | 5.8 Units on a scale STANDARD_DEVIATION 1.3 | 6.0 Units on a scale STANDARD_DEVIATION 1.3 | 6.1 Units on a scale STANDARD_DEVIATION 1.3 |
| Sex: Female, Male Female | 14 Participants | 37 Participants | 23 Participants |
| Sex: Female, Male Male | 3 Participants | 14 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 34 | 0 / 17 |
| serious Total, serious adverse events | 0 / 34 | 0 / 17 |
Outcome results
Primary
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.
Time frame: Baseline and 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lateral Branch Neurotomy | Pain Status Change for Sacroiliac Joint Pain Intensity | -2.4 units on a scale | Standard Deviation 2.7 |
| Sham Procedure | Pain Status Change for Sacroiliac Joint Pain Intensity | -0.8 units on a scale | Standard Deviation 2.4 |
p-value: 0.035t-test, 2 sided
Other Pre-specified
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.
Time frame: Baseline and 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lateral Branch Neurotomy | Pain Status Change for Sacroiliac Joint Pain Intensity | -2.5 units on a scale | Standard Deviation 2.6 |
Other Pre-specified
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.
Time frame: Baseline and 9 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lateral Branch Neurotomy | Pain Status Change for Sacroiliac Joint Pain Intensity | -2.7 units on a scale | Standard Deviation 2.7 |