Sacroiliac Joint PainPhase 4LINQTNCT07558278
LINQ® Procedure vs. Conventional Medical Management for Sacroiliac Dysfunction
A Phase 4 study testing Bone Allograft and Conventional Medical Management (CMM) in people with Sacroiliac Joint Pain, run by PainTEQ, LLC at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Sacroiliac Joint Pain
- What is being tested?
- Bone Allograft and Conventional Medical Management (CMM)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 1 Jul 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 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.
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- 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
- 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 (3) of five (5) SIJ-specific physical examination maneuvers (FABER test, Gaenslen's test, Distraction, Thigh Thrust, Compression); and iii. At least 75% reduction in pain, with associated improvement in previously painful maneuvers, for the expected duration of action following two (2) image-guided, contrast-enhanced intra-articular diagnostic SIJ injections, performed on separate visits using anesthetics with different durations of action; and iv. Completion of at least one (1) therapeutic intra-articular SIJ injection (e.g., corticosteroid injection) within the past 12 months.
- Baseline Disability and Pain Severity
- 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
- 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
- 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 subject has agreed to undergo this treatment.
- 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.
Who cannot join
- Exclusion Criteria Subjects 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
- Presence of severe low back pain attributable to other spinal pathology, including but not limited to lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, or lumbar vertebral body fracture.
- Other Sacroiliac Pathology
- Presence of known sacroiliac joint pathology other than degenerative SIJ dysfunction, including inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondyloarthropathies), tumor, infection, acute fracture, or crystal arthropathy.
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- Non-SIJ Pain Syndromes
- History of coccydynia or prior coccygectomy, endometriosis, cluneal neuralgia, or pudendal neuralgia.
- Recent Sacral Interventions
- Prior sacral radiofrequency ablation performed within 6 months prior to enrollment.
- Recent Pelvic Trauma
- History of major pelvic trauma within 12 months prior to enrollment.
- Severe Osteoporosis
- 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
- Current use of medications known to adversely affect bone quality or soft-tissue healing, as determined by the Investigator.
- Anatomic Constraints
- Anatomic anomalies or defects that, in the Investigator's opinion, would preclude safe or biomechanically appropriate device placement.
- Systemic Inflammatory or Rheumatologic Disease
- Presence of a chronic inflammatory rheumatologic condition, such as rheumatoid arthritis.
- Centralized Pain Syndromes
- Current diagnosis of fibromyalgia.
- Infection Risk
- Evidence of current local or systemic infection that would increase surgical risk.
- High-Dose Opioid Therapy (≥90 MME/day)
- Current use of systemic opioid analgesics at Screening/Baseline with an average daily dose ≥90 morphine milligram equivalents (MME/day), based on medication reconciliation (prescription records and subject report) and standard MME conversion factors.
- Current Nicotine Use (Self-Reported)
- Self-reported use of any nicotine-containing products (including smoking, vaping/e-cigarettes, cigars, pipes, smokeless tobacco, nicotine pouches, and nicotine replacement products) within 6 weeks prior to Screening/Baseline.
- Secondary Gain or Litigation
- Currently receiving or actively seeking workers' compensation or disability benefits or involved in injury-related litigation.
- Pregnancy
- Currently pregnant or planning to become pregnant within two (2) years following enrollment, as self-reported.
- Vulnerable Populations
- Individuals who are prisoners or wards of the state.
- Substance Abuse
- Known or suspected active drug or alcohol abuse, including opioid misuse.
- Psychiatric Conditions
- Diagnosed psychiatric disorder (e.g., schizophrenia, major depressive disorder, personality disorder) that, in the Investigator's judgment, could interfere with study participation.
- Concurrent Interventional Research
- Current participation in another clinical trial.
- Neurologic Conditions Affecting Rehabilitation
- 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 reporting, or interpretation of study endpoints.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Procura Pain and Spine
Shenandoah, Texas, 77384
Courtney Harvey, (713) 714-1399, courtney@procurapain.com
About this study
Official title: LINQT: An Open Label Randomized, Controlled, Multicenter, Prospective, Long Term Clinical Study on the Minimally Invasive Posterior Sacroiliac Fusion Device LINQ® System
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).
Read the detailed description
Prospective, multi-center, open-label, randomized, clinical study. Subjects who meet the eligibility criteria and are enrolled will be randomized 2:1 to LINQ or CMM. After their 6 Month evaluations are complete, subjects in the Control Group can elect to stay in the CMM Arm or crossover to receive the LINQ procedure.
Each subject will undergo a Screening Visit, Randomization, Baseline Procedure or CMM Initiation Visit, and Follow-Up Visits through 24 Months. The primary endpoint is evaluated at the 6 Month Follow Up Visit.
Subjects that elect to crossover from the Control Group to the Treatment Group at the 6 Month Visit, will have Procedure and Follow-Up Visits through 18 Months post crossover procedure.
- Conditions
- Sacroiliac Joint Pain
- Being tested
- Bone Allograft, Conventional Medical Management (CMM)
- Keywords
- sacroiliac joint dysfunction, LINQ, SI Joint Pain, SI Joint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone AllograftProcedure or surgery
The LINQ system is intended for use in patients with SIJ disease by implantation of compatible implants to prepare the SIJ for allograft fusion.
Conventional Medical Management (CMM)Other
Also called Non-Surgical Management
CMM Control Arm shall receive standardized, stepwise, non-surgical management for SIJ pain.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm (LINQ Procedure) | Active comparator | Subjects randomized to the Treatment Arm will undergo the LINQ Procedure. Receives: Procedure: Bone Allograft |
| Conventional Medical Management (CMM) | Active comparator | Subjects randomized to the CMM Control Arm shall receive standardized, stepwise, non-surgical management for SIJ pain. Receives: Other: Conventional Medical Management (CMM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Success Responder Rate at Month 6
Unit of Measure: Percentage of participants
Description: The primary endpoint is a single binary (Yes/No) composite responder classification per subject at Month 6. A subject is classified as a composite success responder ONLY if ALL three of the following criteria are met:
Pain Improvement: Reduction in SIJ pain VAS score of ≥20 mm from baseline to Month 6 (VAS measured on 0-100 mm scale).
Safety: Absence of any device-related or procedure-related SAEs through Month 6 (Day 180).
Surgical Reintervention: No surgical reintervention for SIJ fusion through Month 6 (Day 180), including device removal (complete or partial), device revision or replacement, or reoperation at the index SIJ.
Subjects meeting all three components are classified as responders; the outcome is reported as the percentage (%) of participants classified as responders.
Measured: Month 6
Secondary outcomes (8)
Proportion of Participants Achieving Both a ≥20 mm Reduction in SIJ Pain VAS and a ≥15 Point Reduction in ODI
Composite responder analysis based on two validated patient-reported outcomes. Pain intensity is measured using a 100 mm Visual Analog Scale (VAS) anchored by 0 mm ("no pain") and 100 mm ("worst imaginable pain"); higher scores indicate greater pain severity.
Disability is measured using the Oswestry Disability Index (ODI), a 10-item questionnaire assessing low back pain-related disability across domains of daily living, scored 0-100; higher scores indicate greater disability.
A participant is classified as a responder if they achieve BOTH a reduction of ≥20 mm from baseline in sacroiliac joint (SIJ) pain VAS AND a reduction of ≥15 points from baseline in ODI. The proportion of responders will be reported and a higher proportion indicates greater clinical improvement.
Measured: Months 1, 3, 6, 12, 18, 24
Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) is a patient-reported measure of pain intensity assessed using a 100 mm horizontal line anchored by 0 mm ("no pain") and 100 mm ("worst imaginable pain"). Scores range from 0 to 100 mm, with higher scores indicating greater pain severity. Change from baseline in VAS score and proportion of participants achieving a minimum clinically important difference (MCID) in pain intensity will be assessed. MCID is defined as a reduction of ≥20 mm from baseline on the 0-100 mm scale. Higher proportions indicate greater clinical improvement.
Measured: Months 1, 3, 6, 12, 18, 24.
Oswestry Disability Index (ODI)
The Oswestry Disability Index (ODI) is a validated patient-reported questionnaire assessing disability related to low back pain across 10 domains of daily living. Scores range from 0 to 100, with higher scores indicating greater disability. Change from baseline in ODI score and proportion of participants achieving a minimum clinically important difference (MCID) in disability will be assessed using the Oswestry Disability Index (ODI). MCID is defined as a reduction of ≥15 points from baseline on the 0-100 scale. Higher proportions indicate greater clinical improvement.
Measured: Months 1, 3, 6, 12, 18, 24
Patient-Reported Outcomes Measurement Information System (PROMIS-29+2)
The Patient-Reported Outcomes Measurement Information System 29-Item Profile v2.1 + 2 (PROMIS-29+2) assesses multiple health domains including physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles, pain interference, and cognitive function. Domain scores are reported as T-scores standardized to a mean of 50 and standard deviation of 10 in the general population, with a typical range of approximately 20 to 80. Higher scores indicate more of the domain being measured (e.g., worse symptoms for anxiety, depression, fatigue, sleep disturbance, pain interference, and cognitive concerns; and better functioning for physical function and social participation). Change from baseline in T-scores will be evaluated.
Measured: Months 1, 3, 6, 12, 18, 24
EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire
The EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire is a standardized measure of health-related quality of life assessing five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses are converted into a single index score using country-specific value sets. The index score typically ranges from less than 0 (health states worse than death) to 1 (perfect health), where higher scores indicate better health status. Change from baseline in EQ-5D-5L index scores will be evaluated.
Measured: Months 1, 3, 6, 12, 18, 24
Patient Global Impression of Change (PGIC)
The Patient Global Impression of Change (PGIC) is a patient-reported measure assessing overall change in health status since the start of treatment. It is a 7-point ordinal scale with responses ranging from 1 ("very much improved") to 7 ("very much worse"). Lower scores indicate greater improvement, and higher scores indicate worsening. The distribution of PGIC responses across categories will be summarized.
Measured: Months 1, 3, 6, 12, 18, 24
Medication use
Medication use will be assessed at each visit, including opioid and non-opioid pain medications. Opioid consumption will be quantified as daily morphine milligram equivalents (MME), calculated using standard conversion factors. MME values range from 0 upward, with higher values indicating greater opioid use. Change from baseline in daily MME will be evaluated. Additional analyses may include the proportion of participants reducing or discontinuing opioid use over time.
Measured: Months 1, 3, 6, 12, 18, 24
Incidence of Adverse Events
Safety will be assessed by evaluating all adverse events (AEs) reported from the time of the index procedure through study completion. AEs will be characterized by severity, seriousness, and relatedness to the device and/or procedure. The number and proportion of participants experiencing one or more device- or procedure-related AEs and serious adverse events (SAEs) will be summarized.
Measured: Months 1, 3, 6, 12, 18, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start1 Jul 2026
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac Joint PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PainTEQ, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558278
- Sponsor's protocol ID
- PTQ-002
- Acronym
- LINQT
- Status last verified
- Sep 2026
- First submitted
- 23 Apr 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sponsored Study
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LINQT: An Open Label Randomized, Controlled, Multicenter, Prospective, Long Term Clinical Study on the Minimally Invasive Posterior Sacroiliac Fusion Device LINQ® System
- ClinicalTrials.gov ID
- NCT07558278
- Acronym / sponsor ID
- LINQT / PTQ-002
- Conditions
- Sacroiliac Joint Pain
- Keywords
- sacroiliac joint dysfunction, LINQ, SI Joint Pain, SI Joint
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- PainTEQ, LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Prospective, multi-center, open-label, randomized, clinical study. Subjects who meet the eligibility criteria and are enrolled will be randomized 2:1 to LINQ or CMM. After their 6 Month evaluations are complete, subjects in the Control Group can elect to stay in the CMM Arm or crossover to receive the LINQ procedure.
Each subject will undergo a Screening Visit, Randomization, Baseline Procedure or CMM Initiation Visit, and Follow-Up Visits through 24 Months. The primary endpoint is evaluated at the 6 Month Follow Up Visit.
Subjects that elect to crossover from the Control Group to the Treatment Group at the 6 Month Visit, will have Procedure and Follow-Up Visits through 18 Months post crossover procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm (LINQ Procedure) | Active comparator | Procedure: Bone AllograftSubjects randomized to the Treatment Arm will undergo the LINQ Procedure. |
| Conventional Medical Management (CMM) | Active comparator | Other: Conventional Medical Management (CMM)Subjects randomized to the CMM Control Arm shall receive standardized, stepwise, non-surgical management for SIJ pain. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- To be eligible to participate in this study, a subject must meet ALL of the following criteria, as determined by the Investigator:
Key exclusion criteria (43 listed)
- Exclusion Criteria Subjects must meet none of the following criteria to be eligible for participation in this study, as determined by the Investigator:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone AllograftThe LINQ system is intended for use in patients with SIJ disease by implantation of compatible implants to prepare the SIJ for allograft fusion. | Procedure or surgery | Treatment Arm (LINQ Procedure) |
| Conventional Medical Management (CMM)Also: Non-Surgical ManagementCMM Control Arm shall receive standardized, stepwise, non-surgical management for SIJ pain. | Other | Conventional Medical Management (CMM) |
Primary outcome
Composite Success Responder Rate at Month 6
Time frame: Month 6
Unit of Measure: Percentage of participants Description: The primary endpoint is a single binary (Yes/No) composite responder classification per subject at Month 6. A subject is classified as a composite success responder ONLY if ALL three of the following criteria are met: Pain Improvement: Reduction in SIJ pain VAS score of ≥20 mm from baseline to Month 6 (VAS measured on 0-100 mm scale). Safety: Absence of any device-related or procedure-related SAEs through Month 6 (Day 180). Surgical Reintervention: No surgical reintervention for SIJ fusion through Month 6 (Day 180), including device removal (complete or partial), device revision or replacement, or reoperation at the index SIJ. Subjects meeting all three components are classified as responders; the outcome is reported as the percentage (%) of participants classified as responders.
8 secondary outcomes
Proportion of Participants Achieving Both a ≥20 mm Reduction in SIJ Pain VAS and a ≥15 Point Reduction in ODI
Time frame: Months 1, 3, 6, 12, 18, 24
Visual Analog Scale (VAS)
Time frame: Months 1, 3, 6, 12, 18, 24.
Oswestry Disability Index (ODI)
Time frame: Months 1, 3, 6, 12, 18, 24
Patient-Reported Outcomes Measurement Information System (PROMIS-29+2)
Time frame: Months 1, 3, 6, 12, 18, 24
EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire
Time frame: Months 1, 3, 6, 12, 18, 24
Patient Global Impression of Change (PGIC)
Time frame: Months 1, 3, 6, 12, 18, 24
Medication use
Time frame: Months 1, 3, 6, 12, 18, 24
Incidence of Adverse Events
Time frame: Months 1, 3, 6, 12, 18, 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No. Sponsored Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bone Allograft and Conventional Medical Management (CMM) in people with Sacroiliac Joint Pain, run by PainTEQ, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lalit Venkatesan, PhD (18552487246, lalit.venkatesan@painteq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Success Responder Rate at Month 6 (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.