Not Yet RecruitingPhase 4

LINQ® Procedure vs. Conventional Medical Management for Sacroiliac Dysfunction

200 participantsStarted 2026-07-01

Plain-language summary

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).

Who can participate

Age range21 Years

SexALL

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Inclusion criteria

✓. Age and Body Mass Index (BMI)
✓. Adult subjects 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
✓. Baseline Disability and Pain Severity

Exclusion criteria

✕. 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
✕. Other Sacroiliac Pathology
✕. Non-SIJ Pain Syndromes
✕. Recent Sacral Interventions
✕. Recent Pelvic Trauma
✕. Severe Osteoporosis
✕. Medications Detrimental to Bone or Soft-Tissue Healing

What they're measuring

Composite Success Responder Rate at Month 6

Timeframe: Month 6

Trial details

NCT IDNCT07558278

SponsorPainTEQ, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-01

Contact for this trial

Lalit Venkatesan, PhD

18552487246 lalit.venkatesan@painteq.com

View on ClinicalTrials.gov More Sacroiliac Joint Pain trials