Low Back PainNCT04449835
The Intracept Global Registry ( TIGR ) - Pilot Study
An observational study of Low Back Pain, run by Relievant Medsystems, Inc. at 1 site in United States.
Trial summary
The Intracept Global Registry is a prospective, noninterventional, observational global post market independent data collection of the ongoing effectiveness, safety, and satisfaction outcomes for patients treated with the Intracept Procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Intracept Procedure
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2020to 1 Dec 2022
- How long will I take part?
- 2 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients that have the Intracept procedure and whose treating physician is referring to the registry
Who may be able to join
- All patients scheduled for the Intracept procedure and whose treating physician is referring to the registry
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Intracept Global Registry
The Intracept Global Registry is a prospective, noninterventional, observational global post market independent data collection of the ongoing effectiveness, safety, and satisfaction outcomes for patients treated with the Intracept Procedure. This registry will be conducted according to Good Clinical Practice (GCP) guidelines, including participant verbal informed consent and Independent Review Board (IRB) / Ethics Committee (EC) approval and oversight.
Registry design, conduct, analysis, and reporting are overseen by the Principal Investigator (PI) and the cross-specialty TIGR Physician Steering Committee.
Read the detailed description
Participants in the registry will have seven study visits over a period of five years (one prior to procedure and 6 post their procedure). Study visits will be conducted via telephone by a third-party CRO and independent clinical research coordinators. Participants will be verbally consented and then evaluated via telephonic study visits at baseline (prior to procedure) and at 3, 12, 24, 36, 48, and 60 months post their Intracept Procedure.
Primary and secondary objectives are based on patient reported outcomes for functional improvement, pain reduction, and physical and mental health pre and post procedure. The study will also look at utilization of injections and pain interventions/surgery for treatment of low back pain post Intracept.
- Conditions
- Low Back Pain
- Being tested
- Intracept Procedure
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracept ProcedureProcedure or surgery
radio frequency ablation of the basivertebral nerve for the relief of chronic vertebrogenic low back pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI) Reduction
Validated questionnaire of low back pain related disability. Comprised of 10 questions evaluating the impact of low back pain on activities of daily living. The ODI is scored on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). Comparison of mean ODI baseline to 3 months.
Measured: 3 months post procedure
Secondary outcomes (6)
Oswestry Disability Index (ODI) improvement
Mean improvement in ODI scores from baseline (scale 0 to 100)
Measured: 3, 12, 24, 36, 48 and 60 months post procedure
Numeric Pain Score
Mean reduction in patient reported low back pain from baseline (scale 0 no pain to 10 worst pain imaginable)
Measured: 3, 12, 24, 36, 48 and 60 months post procedure
Combined Responder Rates (improvement thresholds of ODI ≥ 15 and NPS ≥ 2)
Percent of responders meeting both thresholds
Measured: 3, 12, 24, 36, 48 and 60 months post procedure
PROMIS 29 Change
Mean change in PROMIS-29 from baseline
Measured: 3, 12, 24, 36, 48 and 60 months post procedure
Injections utilization compared to baseline
Numbers of injections post procedure compared to baseline
Measured: 3, 12, 24, 36, 48 and 60 months post procedure
Post ablation pain interventions/surgeries
Numbers of pain interventions/surgeries post procedure compared to baseline
Measured: 3, 12, 24, 36, 48 and 60 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start31 Jul 2020
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Why it stopped: Pilot Study converted to NCT 05660512 prospective single arm cohort study
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 Low Back 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Relievant Medsystems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- M Squared Associates, Inc.
- Responsible party
- Principal investigator, Zack McCormick, University of Utah
- Investigators
- Zachary McCormick, MD, FAAPMR, Principal investigator, Spine and Pain Medicine, University of Utah School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449835
- Sponsor's protocol ID
- CIP 0014
- Status last verified
- Jan 2023
- First submitted
- 23 Jun 2020
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McCormick ZL, Fogarty AE, Conger A, Burnham T, Kendall R, Dickenson BA, Kanjanapanang N, Curtis TM, Sen H, Glinka Przybysz A, Clark T, Smolinski K, Wagner G, Teramoto M, Cooper AN. The effectiveness of basivertebral nerve radiofrequency ablation for the treatment of vertebrogenic low back pain: 1-year results of a prospective real-world cohort study. Pain Med. 2026 Mar 1;27(3):254-261. doi: 10.1093/pm/pnaf122.
PubMed 40891888
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Intracept Global Registry
- ClinicalTrials.gov ID
- NCT04449835
- Acronym / sponsor ID
- CIP 0014
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Pilot Study converted to NCT 05660512 prospective single arm cohort study
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Relievant Medsystems, Inc.Industry (pharma, biotech, devices)
- Collaborators
- M Squared Associates, Inc.
- Study start
- 31 Jul 2020 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 29 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 Intracept Global Registry is a prospective, noninterventional, observational global post market independent data collection of the ongoing effectiveness, safety, and satisfaction outcomes for patients treated with the Intracept Procedure. This registry will be conducted according to Good Clinical Practice (GCP) guidelines, including participant verbal informed consent and Independent Review Board (IRB) / Ethics Committee (EC) approval and oversight.
Registry design, conduct, analysis, and reporting are overseen by the Principal Investigator (PI) and the cross-specialty TIGR Physician Steering Committee.
Detailed description
Participants in the registry will have seven study visits over a period of five years (one prior to procedure and 6 post their procedure). Study visits will be conducted via telephone by a third-party CRO and independent clinical research coordinators. Participants will be verbally consented and then evaluated via telephonic study visits at baseline (prior to procedure) and at 3, 12, 24, 36, 48, and 60 months post their Intracept Procedure.
Primary and secondary objectives are based on patient reported outcomes for functional improvement, pain reduction, and physical and mental health pre and post procedure. The study will also look at utilization of injections and pain interventions/surgery for treatment of low back pain post Intracept.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients that have the Intracept procedure and whose treating physician is referring to the registry
Key inclusion criteria (1 listed)
- All patients scheduled for the Intracept procedure and whose treating physician is referring to the registry
Key exclusion criteria (1 listed)
- No exclusion criteria
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 |
|---|---|---|
| Intracept Procedureradio frequency ablation of the basivertebral nerve for the relief of chronic vertebrogenic low back pain | Procedure or surgery | – |
Primary outcome
Oswestry Disability Index (ODI) Reduction
Time frame: 3 months post procedure
Validated questionnaire of low back pain related disability. Comprised of 10 questions evaluating the impact of low back pain on activities of daily living. The ODI is scored on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). Comparison of mean ODI baseline to 3 months.
6 secondary outcomes
Oswestry Disability Index (ODI) improvement
Time frame: 3, 12, 24, 36, 48 and 60 months post procedure
Numeric Pain Score
Time frame: 3, 12, 24, 36, 48 and 60 months post procedure
Combined Responder Rates (improvement thresholds of ODI ≥ 15 and NPS ≥ 2)
Time frame: 3, 12, 24, 36, 48 and 60 months post procedure
PROMIS 29 Change
Time frame: 3, 12, 24, 36, 48 and 60 months post procedure
Injections utilization compared to baseline
Time frame: 3, 12, 24, 36, 48 and 60 months post procedure
Post ablation pain interventions/surgeries
Time frame: 3, 12, 24, 36, 48 and 60 months post procedure
Results and safety
The study was stopped early (reason given: Pilot Study converted to NCT 05660512 prospective single arm cohort study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Derived from this study: PubMed 40891888McCormick ZL, Fogarty AE, Conger A, Burnham T, Kendall R, Dickenson BA, Kanjanapanang N, Curtis TM, Sen H, Glinka Przybysz A, Clark T, Smolinski K, Wagner G, Teramoto M, Cooper AN. The effectiveness of basivertebral nerve radiofrequency ablation for the treatment of vertebrogenic low back pain: 1-year results of a prospective real-world cohort study. Pain Med. 2026 Mar 1;27(3):254-261. doi: 10.1093/pm/pnaf122.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Zachary McCormick, MD, FAAPMR principal investigator
Spine and Pain Medicine, University of Utah School of Medicine
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 Low Back Pain, run by Relievant Medsystems, Inc. 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 5 Jan 2023. 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 was stopped early (reason given: Pilot Study converted to NCT 05660512 prospective single arm cohort study). Results are not available in the source record.
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?
Oswestry Disability Index (ODI) Reduction (time frame: 3 months post procedure). 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 NCT04449835, 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 5 Jan 2023.