Particulate vs. Non-Particulate Steroid for Sacroiliac Joint Injection
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of New Mexico
About this trial
This study will compare two different corticosteroids (dexamethasone and methylprednisolone) for use in sacroiliac joint injections to treat SI joint pain.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Dexamethasone
DrugThis is a non-particulate steroid commonly used to treat SI joint pain.
Methylprednisolone
DrugThis is a particulate steroid commonly used to treat SI joint pain.
2% Lidocaine HCl Injection
DrugLidocaine is a local anesthetic used in SI joint injection procedures to numb the procedure site and helps to confirm SI joint dysfunction when injected with the steroid medication into the SI joint.
Treatment groups
230 Participants
are divided into 2 treatment groupsGroup A: Non-Particulate SteroidExperimental treatment 2 interventions
Group B: Particulate SteroidActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Pain using Numeric Pain Rating Score
Numeric pain rating score is an 11 point scale (0-10) filled out on a form indicating the degree to which the patient experiences pain to assess efficacy of the injection. In this scale a 0, the minimum score, indicates no pain at all with a 10, the maximum score, being the worst pain imaginable. In this study a 50% or greater reduction in numeric pain rating score is considered a successful outcome while failure to achieve at least a 50% improvement as compared to their numeric pain rating score prior to the procedure is considered a poor outcome.
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov