Chronic PainNCT04423120
Clinical Study on a Novel Minimally Invasive Posterior Sacroiliac Fusion Device
An observational study of Chronic Pain, run by PainTEQ, LLC at 1 site in United States.
Trial summary
The PainTEQ study is a prospective, multi-site, prospective, single arm study intended to collect clinical data outcomes data associated with the treatment of sacroiliac disease with the LinQ fusion procedure. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Chronic Pain
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2020to 30 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential study participants will come from the existing patient population of the investigators in each individual practice.
Who may be able to join
- Age 21-70
- Patient has lower back pain for >6 months inadequately responsive to conservative care
- Patient has at least 3 of 4 physical examination maneuvers specific for the SI joint (FABER, Gaenslen test, Stork/Gillete, and Yoman)
- Patient has improvement in lower back pain numeric rating scale (NRS) of at least 50% after injection of local anesthetic into affected SI joint(s) with confirmed arthrogram, within 30-60 min from injection
- Degenerative sacroiliitis as SIJ mediated in in the context of either radiographic evidence of SIJ degeneration, evident on computed tomography or Xrays or a history of prior lumbar fusion.
- SIJ disruption was defined in the study of as SIJ mediated pain in the context of asymmetric widening of SIJ on CT or Xrays or the presence of significant contrast leakage during diagnostic SIJ block
Show all 12Show fewer
- Baseline Oswestry Disability Index (ODI) score of at least 30%
- Baseline Low back/buttock pain score of at least 50 on 0-100 mm visual analog scale
- Patient has signed study-specific informed consent form
- Patient has the necessary mental capacity to consent and participate and is physically able to comply with study protocol requirements
- Patient has medical insurance that covers this standard of care procedure and all other anticipated and unanticipated procedure related care.
- Patient's physician has decided that the best treatment for the patient's sacro-iliac disease is the LinQ system and the patient has agreed to the treatment.
Who cannot join
- Inability to confirm that the pain is arising from the sacroiliac joint
- Current severe back pain due to other causes, such as lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, lumbar radicular pain, and lumbar vertebral body fracture
- SIJ pain secondary to inflammatory conditions, Other known sacroiliac pathology such as: Sacral dysplasia, Inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondylo-arthropathy), Tumor, Infection, Acute fracture, and Crystal arthropathy.
- Radicular pain extending beyond the buttock ≥ 30mm on VAS
- Has complete resolution of pain from the diagnostic SIJ injection lasting 30 days or more
- Has had an injection with corticosteroid into the index SIJ within the last 90 days
Show all 23Show fewer
- Has had any neuraxial injection with corticosteroid within the last 90 days
- Has greater than 50% pain relief from diagnostic medial branch blocks at the L4/5 and/or L5/S1 levels
- Has had a sacral radiofrequency ablation within the last 6 months
- History of any hardware placement within the sacrum or sacroiliac joint
- History of coccydynia or coccygectomy
- Clinical diagnosis of discogenic pain at L4/5 and/or L5/S1
- History of endometriosis or pudendal neuralgia
- History of recent (<1 year) major trauma to pelvis
- Chronic rheumatologic condition (e.g., rheumatoid arthritis)
- Any condition or anatomy that makes treatment with the Linq Implant System infeasible
- Use of medications known to have detrimental effects on bone quality and soft-tissue healing (metabolic bone disease, induced or idiopathic)
- Prominent neurologic condition that would interfere with physical therapy
- Current local or systemic infection that raises the risk of surgery
- Patient currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation.
- Patient is participating in an investigational study or has been involved in an investigational study within 3 months prior to evaluation for participation
- Patient with insurance coverage that does not cover the SI fusion*
- Implanted intrathecal pain pump
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Arm, Multicenter, Prospective, Clinical Study on a Novel Minimally Invasive Posterior Sacroiliac Fusion Device
The PainTEQ study is a prospective, multi-site, prospective, single arm study intended to collect clinical data outcomes data associated with the treatment of sacroiliac disease with the LinQ fusion procedure. Data will be collected using self-report measures including the visual analog scale (VAS) for pain assessment where the participant is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. Other self-report questionnaires will be administered including the Oswestry Disablity Index (ODI) to measure low-back pain and disability, and the Patient-Reported Outcomes Measurement Information System 29 (PROMIS 29) to measure physical, mental, and social health and well-being.
- Conditions
- Chronic Pain
- Medical subject headings
- Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline VAS Sacroiliac Joint (SIJ) pain by at least 20 millimeters
A subject was considered a success if all of the following criteria were met
- Change from baseline VAS SIJ pain by at least 20 mm (Binary success failure composite end point) VAS is a vertical scale, where a higher score depicts more pain (100 mm maximum) and a lower scale depicts less pain (0 mm minimum)
Measured: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
Absence of device related serious adverse events
A subject was considered a success if all of the following criteria were met
- Absence of device related serious adverse events, (Binary success failure composite end point)
Measured: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
Absence of neurological worsening related to the lumbosacral nerve roots
A subject was considered a success if all of the following criteria were met
- Absence of neurological worsening related to the lumbosacral nerve roots, (Binary success failure composite end point)
Measured: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
Absence of surgical reintervention (removal, revision reoperation or supplemental fixation) for SIJ pain
A subject was considered a success if all of the following criteria were met
- Absence of surgical reintervention (removal, revision reoperation or supplemental fixation) for SIJ pain (Binary success failure composite end point)
Measured: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
Secondary outcomes (5)
Change in VAS
- Change in baseline in VAS from baseline at 6 months
Measured: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
Change in ODI
- Change in Oswestry Disability Index at 6 months follow up ODI assesses disability and has 10 sections, each with a point range from 0 (minimum) to 5 (maximum). A higher score translates to a higher percentage, meaning more disability (100% maximum). A lower score translates to a lower percentage, meaning less disability (0% minimum).
Measured: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
Change in PROMIS29
- Change in PROMIS-29 at 6 months follow up. PROMIS 29 assesses pain intensity using a 0-10 numeric rating scale (11 point scale), where a higher score equates to more pain. Other health domains are scored using a Likert scale, where higher scores represent more of the specific domain being measured.
Measured: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
Change in Patient Global Impression of Change (PGIC)
- Change in Patient Satisfaction with PGIC PGIC is on a 7 point scale that depicts a patient's rating on their overall improvement. A lower score translates to a profound improvement and a higher score translates to a salvage improvement.
Measured: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
Change in Morphine milligram equivalent
- Change in MME usage at all time points
Measured: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start13 Mar 2020
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- PainTEQ, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pacific Research Institute
- Responsible party
- Sponsor
- Investigators
- Aaron Calodeny, MD, Principal investigator, Precision Spine Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423120
- Sponsor's protocol ID
- SECURE
- Status last verified
- May 2024
- First submitted
- 4 Jun 2020
- Last updated
- 22 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Calodney A, Azeem N, Buchanan P, Skaribas I, Antony A, Kim C, Girardi G, Vu C, Bovinet C, Vogel R, Li S, Jassal N, Josephson Y, Lubenow T, Lam CM, Deer TR. Safety, Efficacy, and Durability of Outcomes: Results from SECURE: A Single Arm, Multicenter, Prospective, Clinical Study on a Minimally Invasive Posterior Sacroiliac Fusion Allograft Implant. J Pain Res. 2024 Mar 20;17:1209-1222. doi: 10.2147/JPR.S458334. eCollection 2024.
PubMed 38524688
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Multicenter, Prospective, Clinical Study on a Novel Minimally Invasive Posterior Sacroiliac Fusion Device
- ClinicalTrials.gov ID
- NCT04423120
- Acronym / sponsor ID
- SECURE
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- PainTEQ, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Pacific Research Institute
- Study start
- 13 Mar 2020 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 9 Jun 2020 (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 PainTEQ study is a prospective, multi-site, prospective, single arm study intended to collect clinical data outcomes data associated with the treatment of sacroiliac disease with the LinQ fusion procedure. Data will be collected using self-report measures including the visual analog scale (VAS) for pain assessment where the participant is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. Other self-report questionnaires will be administered including the Oswestry Disablity Index (ODI) to measure low-back pain and disability, and the Patient-Reported Outcomes Measurement Information System 29 (PROMIS 29) to measure physical, mental, and social health and well-being.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential study participants will come from the existing patient population of the investigators in each individual practice.
Key inclusion criteria (12 listed)
- Age 21-70
- Patient has lower back pain for >6 months inadequately responsive to conservative care
- Patient has at least 3 of 4 physical examination maneuvers specific for the SI joint (FABER, Gaenslen test, Stork/Gillete, and Yoman)
- Patient has improvement in lower back pain numeric rating scale (NRS) of at least 50% after injection of local anesthetic into affected SI joint(s) with confirmed arthrogram, within 30-60 min from injection
- Degenerative sacroiliitis as SIJ mediated in in the context of either radiographic evidence of SIJ degeneration, evident on computed tomography or Xrays or a history of prior lumbar fusion.
Key exclusion criteria (23 listed)
- Inability to confirm that the pain is arising from the sacroiliac joint
- Current severe back pain due to other causes, such as lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, lumbar radicular pain, and lumbar vertebral body fracture
- SIJ pain secondary to inflammatory conditions, Other known sacroiliac pathology such as: Sacral dysplasia, Inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondylo-arthropathy), Tumor, Infection, Acute fracture, and Crystal arthropathy.
- Radicular pain extending beyond the buttock ≥ 30mm on VAS
- Has complete resolution of pain from the diagnostic SIJ injection lasting 30 days or more
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline VAS Sacroiliac Joint (SIJ) pain by at least 20 millimeters
Time frame: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
A subject was considered a success if all of the following criteria were met 1. Change from baseline VAS SIJ pain by at least 20 mm (Binary success failure composite end point) VAS is a vertical scale, where a higher score depicts more pain (100 mm maximum) and a lower scale depicts less pain (0 mm minimum)
Absence of device related serious adverse events
Time frame: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
A subject was considered a success if all of the following criteria were met 2. Absence of device related serious adverse events, (Binary success failure composite end point)
Absence of neurological worsening related to the lumbosacral nerve roots
Time frame: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
A subject was considered a success if all of the following criteria were met 3. Absence of neurological worsening related to the lumbosacral nerve roots, (Binary success failure composite end point)
Absence of surgical reintervention (removal, revision reoperation or supplemental fixation) for SIJ pain
Time frame: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
A subject was considered a success if all of the following criteria were met 4. Absence of surgical reintervention (removal, revision reoperation or supplemental fixation) for SIJ pain (Binary success failure composite end point)
5 secondary outcomes
Change in VAS
Time frame: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
Change in ODI
Time frame: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
Change in PROMIS29
Time frame: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
Change in Patient Global Impression of Change (PGIC)
Time frame: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
Change in Morphine milligram equivalent
Time frame: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Results publication: PubMed 38524688Calodney A, Azeem N, Buchanan P, Skaribas I, Antony A, Kim C, Girardi G, Vu C, Bovinet C, Vogel R, Li S, Jassal N, Josephson Y, Lubenow T, Lam CM, Deer TR. Safety, Efficacy, and Durability of Outcomes: Results from SECURE: A Single Arm, Multicenter, Prospective, Clinical Study on a Minimally Invasive Posterior Sacroiliac Fusion Allograft Implant. J Pain Res. 2024 Mar 20;17:1209-1222. doi: 10.2147/JPR.S458334. eCollection 2024.
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
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. This study is not recruiting at the moment.
Aaron Calodeny, MD principal investigator
Precision Spine Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic 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 12 inclusion and 23 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: finished, as of the sponsor's last update on 22 May 2024. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline VAS Sacroiliac Joint (SIJ) pain by at least 20 millimeters (time frame: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04423120, which also lists 1 linked publication.
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 22 May 2024.