VaReFi Validity and Reliability of Diagnostic Findings of SI Joint Blocking
Overview
- Phase
- Phase 4
- Intervention
- 0.75% bupivacaine
- Conditions
- SI Joint Pain
- Sponsor
- SI-BONE, Inc.
- Enrollment
- 28
- Locations
- 7
- Primary Endpoint
- Numeric Rating Scale
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of the trial is to confirm the validity and reliability of diagnostic SI joint blocks.
Detailed Description
Subjects with suspected SI joint pain will undergo 3 SI joint blocks, 2 with local anesthetic and 1 sham block. The sequence of blocks is randomly assigned. This study examines both the test-retest reliability of response to diagnostic sacroiliac (SI) joint injection and the specificity of response to local anesthetic or sham block. The goal of the study is to validate the use of diagnostic SI joint block. Subjects with pain suspected to be generated by one SI joint will undergo three diagnostic SI joint blocks each separated by one week. Two blocks will be with local anesthetic (LA) and one will be a sham block (SB). Both the Coordinator (collecting pain assessments) and subject will be blinded to the sequence of blocks (LA or SB each time). The sequence of blocks will be randomly assigned for each subject on study. The subject's participation in the study is complete after 6-month post-procedure assessment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 21-75 at time of screening.
- •Patient has buttocks, groin and/or leg pain suspected to be from one SI joint (left or right).
- •Patient has positive Fortin finger test\*.
- •Patient has a current average SI joint pain rating of at least 5 on 0-10 numerical rating scale\*\*.
- •Patient has at least 3 positive physical SI joint examination findings in the targeted SI joint.
- •Investigator believes that diagnostic SI joint block is indicated now, and that no other (hip/back, etc.) diagnostic test is required at this time.
- •Patient has signed study-specific informed consent form.
- •Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements (including avoiding taking pain medication 8 hours prior to and 4 hours after each scheduled block).
Exclusion Criteria
- •Patient has history of any surgical procedure of the targeted SI joint (except for prior RF ablation of the SI joint).
- •Patient has suspected bilateral SIJ pain and bilateral injections are indicated.
- •Patient has history of chronic pain syndrome (e.g., fibromyalgia).
- •Patient has any medical or other condition that would interfere with study participation or data validity.
- •Patient is currently pregnant.
- •Patient has known allergy to contrast used or local anesthetic used (bupivacaine).
- •Patient has had one or more steroid SI joint injection(s) of the targeted side in the last 3 months.
- •Patient is a prisoner or a ward of the state.
- •Patient is participating in another investigational study related to back or SI joint pain (Exclude if participating in trials other than the SIFI study (NCT01640353) or the INSITE Study (NCT01681004). Subjects on these two SI-BONE sponsored trials may be eligible for VaReFi.)
- •Patient is known or suspected drug or alcohol abuser.
Arms & Interventions
1st sequence
Blinded 3 blocks (2 bupivacaine, 1 sham block)
Intervention: 0.75% bupivacaine
2nd sequence
Blinded 3 blocks (2 bupivacaine, 1 sham block)
Intervention: .75% bupivacaine
3rd sequence
Blinded 3 blocks (2 bupivacaine, 1 sham block)
Intervention: .75% bupivacaine
Outcomes
Primary Outcomes
Numeric Rating Scale
Time Frame: Baseline, 30 minutes and 60 minutes, 2 and 4 hours post injection (x 3 injections, each 1 week apart), and 1 month post 3rd injection visit (7 weeks post 1st injection).
Change in SI joint pain from prior to injection to 30 minutes, 60 minutes, 2 hours, 4 hours after injection. Changes compared over 3 injections, where type of block is blinded. Is response to bupivacaine different than response to sham block Is response to bupivacaine during second injection similar to that during first injection?
Secondary Outcomes
- Subgroup analysis by diagnosis at 1 month post 3rd block (7 weeks post 1st injection) and 6 month post 3rd injection visit ( 27 weeks post 1st injection).(7 weeks after 1st block & and 27 weeks after 1st block)