Sacro-Iliac Spondylosis
Conditions
Brief summary
Comparing two different corticosteroids (dexamethasone and triamcinolone) for use in sacroiliac joint injections
Detailed description
Patients eligible for a sacroiliac joint injection will be randomized to receive one of two different steroids, dexamethasone or triamcinolone. The response immediately after injection will be assessed to confirm the diagnosis, and then they will be followed for three month to assess the degree of pain relief experienced
Interventions
DRUGDexamethasone
Dexamethasone injection into the sacroiliac joint
DRUGTriamcinolone Acetonide
Triamcinolone injection into the sacroiliac joint
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Aged \>18, capable of understanding and providing consent in English, capable of complying with the outcome instruments used, capable of attending all planned follow up visits * Unilateral low back/buttocks pain of at least 2 weeks. * Patient reported 7 day average of numeric pain rating score (NPRS) low back/buttocks pain of at least 5/10 at baseline evaluation * Clinical diagnosis of sacroiliac joint pain as diagnosed by a board certified Physiatrist including history of low back/buttocks pain and at least 2 positive physical exam findings (including positive fortin finger sign, pain with palpation of posterior superior iliac spine, positive FABER's test, positive Gaenslan's test, positive sacral distraction, positive thigh thrust, positive lateral compression, positive sacral thrust) * Patient consents to sacroiliac joint corticosteroid injection in a shared decision-making process with the treating physician. * 80% or more relief of index pain within first 5-15 minutes after injection
Exclusion criteria
* Clinical suspicion of alternative process is greater than clinical suspicion of sacroiliac joint pain * Those receiving remuneration for their pain treatment (e.g., disability, worker's compensation). * Those involved in active litigation relevant to their pain. * Those unable to read English and complete the assessment instruments. * Those unable to attend follow up appointments * The patient is incarcerated. * History of prior sacroiliac joint fusion * Progressive lower extremity neurologic deficit (from active radiculopathy, unhealed radiculopathy, or neuromuscular disease) * Sacroiliac joint steroid injection within the prior 12 months * 2 Positive lumbar medial branch blocks within the past 12 months * Radiofrequency ablation of the lumbar spine within the past 12 months * Lumbar facet steroid injections within the past 12 months * Prior epidural steroid injection within the prior 3 months in any location within the spine. * Possible pregnancy or other reason that precludes the use of fluoroscopy. * Allergy to steroid, contrast media, or local anesthetics. * BMI\>40. * Systemic inflammatory arthritis (e.g., rheumatoid arthritis, ankylosing spondylitis, lupus). * Active infection or treatment of infection with antibiotics within the past 7 days. * Medical conditions causing significant functional disability (e.g., stroke, decompensated COPD, decompensated heart failure) * Chronic widespread pain or somatoform disorder (e.g. fibromyalgia). * Addictive behavior, severe clinical depression, or psychotic features.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Using Numeric Pain Rating Score | Baseline to 3 months; Average value at month 3 reported | Numeric pain rating score, 11 point scale (0-10) filled out on a form indicating the degree of relief/discomfort after the injection. Pain was assessed monthly from baseline to 3 months following the injection. The average value at month 3 is reported. |
Countries
United States
Participant flow
Pre-assignment details
18 of the 41 patients enrolled had a negative diagnostic response to initial injection and were not followed due to the negative screen after enrollment
Participants by arm
| Arm | Count |
|---|---|
| Dexamethasone dexamethasone injected into the sacroiliac joint
Dexamethasone: Dexamethasone injection into the sacroiliac joint | 9 |
| Triamcinolone triamcinolone injected into the sacroiliac joint
Triamcinolone Acetonide: Triamcinolone injection into the sacroiliac joint | 14 |
| Total | 23 |
Baseline characteristics
| Characteristic | Triamcinolone | Total | Dexamethasone |
|---|---|---|---|
| Age, Continuous | 56.5 years STANDARD_DEVIATION 15.7 | 57.8 years STANDARD_DEVIATION 16.8 | 59.8 years STANDARD_DEVIATION 19.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 22 Participants | 9 Participants |
| Sex: Female, Male Female | 9 Participants | 14 Participants | 5 Participants |
| Sex: Female, Male Male | 5 Participants | 9 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 14 |
| other Total, other adverse events | 0 / 9 | 0 / 14 |
| serious Total, serious adverse events | 0 / 9 | 0 / 14 |
Outcome results
Primary
Pain Using Numeric Pain Rating Score
Numeric pain rating score, 11 point scale (0-10) filled out on a form indicating the degree of relief/discomfort after the injection. Pain was assessed monthly from baseline to 3 months following the injection. The average value at month 3 is reported.
Time frame: Baseline to 3 months; Average value at month 3 reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexamethasone | Pain Using Numeric Pain Rating Score | 4.2 units on a scale | Standard Deviation 2.7 |
| Triamcinolone | Pain Using Numeric Pain Rating Score | 4.4 units on a scale | Standard Deviation 2.1 |