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New treatment option for Sacroiliac Joint Pain
Official title LINQ® Procedure vs. Conventional Medical Management for Sacroiliac Dysfunction
ClinicalTrials.gov ID: NCT07558278
What this study is testing
- What it's testing
- The objective of this clinical evaluation is to assess the safety and effectiveness of LINQ fusion procedure for treatment of sacroiliac joint (SIJ) dysfunction compared to Conservative Medical Management (CMM).
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- To be eligible to participate in this study, a subject must meet ALL of the following criteria, as determined by the Investigator:
- Age and Body Mass Index (BMI)
- Adult people aged ≥ 21 years at screening.
- BMI ≤ 40.
- Chronic SIJ-Related Pain
You likely can't join if
- Exclusion Criteria people must meet none of the following criteria to be eligible for participation in this study, as determined by the Investigator:
- Pain Source Uncertainty a. Inability to confirm, in the Investigator's clinical judgment, that the subject's primary pain generator is the sacroiliac...
- Alternative Primary Spine Pathology a. Presence of severe low back pain attributable to other spinal pathology, including but not limited to lumbar...
- Other Sacroiliac Pathology a. Presence of known sacroiliac joint pathology other than degenerative SIJ dysfunction, including inflammatory...
- Non-SIJ Pain Syndromes a. History of coccydynia or prior coccygectomy, endometriosis, cluneal neuralgia, or pudendal neuralgia.
- Recent Sacral Interventions a. Prior sacral radiofrequency ablation performed within 6 months prior to enrollment.
See the full eligibility criteria
Who can join
- To be eligible to participate in this study, a subject must meet ALL of the following criteria, as determined by the Investigator:
- Age and Body Mass Index (BMI)
- Adult people aged ≥ 21 years at screening.
- BMI ≤ 40.
- Chronic SIJ-Related Pain
- Has experienced low back and/or buttock pain for at least 6 months that has been inadequately responsive to non-surgical management.
- Has experienced nonradicular pain that is maximal below the L5 vertebrae, localized over the posterior SIJ, and consistent with SIJ pain.
- Diagnosis of SIJ Dysfunction a. Has a diagnosis of SIJ dysfunction (degenerative sacroiliitis or SIJ disruption) based on ALL of the following: i. A positive Fortin's finger test; and ii. Pain elicited at least three...
- Baseline Disability and Pain Severity a. Baseline Oswestry Disability Index (ODI) score ≥30%; and b. Baseline SI joint pain score of ≥60 mm on a 100 mm Visual Analog Scale (VAS).
- Nicotine Abstinence a. Is able and willing to completely avoid all forms of nicotine (including smoking, vaping, e-cigarettes, tobacco, or nicotine pouches) for the entire duration of the study.
- Treatment Decision a. The treating physician has independently determined that the LINQ procedure is an appropriate treatment option for the subject's SIJ dysfunction in the course of routine clinical care, and the...
- Informed Consent and Compliance
- Is willing and capable of providing written informed consent; and
- Is willing and able to comply with all study-related requirements, procedures, and follow-up visits.
What rules you out
- Exclusion Criteria people must meet none of the following criteria to be eligible for participation in this study, as determined by the Investigator:
- Pain Source Uncertainty a. Inability to confirm, in the Investigator's clinical judgment, that the subject's primary pain generator is the sacroiliac joint.
- Alternative Primary Spine Pathology a. Presence of severe low back pain attributable to other spinal pathology, including but not limited to lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis...
- Other Sacroiliac Pathology a. Presence of known sacroiliac joint pathology other than degenerative SIJ dysfunction, including inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated...
- Non-SIJ Pain Syndromes a. History of coccydynia or prior coccygectomy, endometriosis, cluneal neuralgia, or pudendal neuralgia.
- Recent Sacral Interventions a. Prior sacral radiofrequency ablation performed within 6 months prior to enrollment.
- Recent Pelvic Trauma a. History of major pelvic trauma within 12 months prior to enrollment.
- Severe Osteoporosis a. Prior diagnosis or suspicion of severe osteoporosis, defined as a prior bone mineral density T-score of \< -2.5 or a history of osteoporotic fracture.
- Medications Detrimental to Bone or Soft-Tissue Healing a. Current use of medications known to adversely affect bone quality or soft-tissue healing, as determined by the Investigator.
- Anatomic Constraints a. Anatomic anomalies or defects that, in the Investigator's opinion, would preclude safe or biomechanically appropriate device placement.
- Systemic Inflammatory or Rheumatologic Disease a. Presence of a chronic inflammatory rheumatologic condition, such as rheumatoid arthritis.
- Centralized Pain Syndromes a. Current diagnosis of fibromyalgia.
- Infection Risk a. Evidence of current local or systemic infection that would increase surgical risk.
- High-Dose Opioid Therapy (≥90 MME/day) a. Current use of systemic opioid analgesics at Screening/Baseline with an average daily dose ≥90 morphine milligram equivalents (MME/day), based on medication reconciliation...
- Current Nicotine Use (Self-Reported) a. Self-reported use of any nicotine-containing products (including smoking, vaping/e-cigarettes, cigars, pipes, smokeless tobacco, nicotine pouches, and nicotine replacement...
- Secondary Gain or Litigation a. Currently receiving or actively seeking workers' compensation or disability benefits or involved in injury-related litigation.
- Pregnancy a. Currently pregnant or planning to become pregnant within two (2) years following enrollment, as self-reported.
- Vulnerable Populations a. Individuals who are prisoners or wards of the state.
- Substance Abuse a. Known or suspected active drug or alcohol abuse, including opioid misuse.
- Psychiatric Conditions a. Diagnosed psychiatric disorder (e.g., schizophrenia, major depressive disorder, personality disorder) that, in the Investigator's judgment, could interfere with study participation.
- Concurrent treatment Research a. Current participation in another clinical trial.
- Neurologic Conditions Affecting Rehabilitation a. Presence of a significant neurologic disorder that would interfere with participation in physical therapy or post procedural rehabilitation.
- Other Confounding Medical Conditions a. Any other medical condition or pain condition not intended to be treated in this study that, in the Investigator's judgment, could interfere with study procedures, accurate pain...
The study team makes the final eligibility decision.
Where it's taking place
- Shenandoah, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenandoah, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.