Low Back PainPhase 4NCT05692440
Basivertebral Nerve Ablation With the Intracept Procedure
A Phase 4 study testing Intracept Procedure in people with Low Back Pain, run by Neuro Spine and Pain Center of Key West at 1 site in United States.
Trial summary
This is an independent prospective, noninterventional, single arm post market data collection of the patient-reported effectiveness, ongoing safety, and satisfaction outcomes for patients treated with intraosseous basivertebral nerve ablation using the Intracept Procedure at a single study site. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Intracept Procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2021to 1 Jun 2026
- Phase
- Phase 4
- 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 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients ≥18 years of age
- Patients who have experienced chronic low back pain for ≥6 months.
- Patients who have not responded to at least 6 months of conservative care.
- Patients with Modic type 1 or 2 changes.
Who cannot join
- Patients with severe cardiac or pulmonary disease.
- Patients with active systemic infection or localized infection in the treatment area.
Trial locations and contacts
1 site in 1 country.
United States1 site
Neuro Spine and Pain Center of Key West
Key West, Florida, 33040
About this study
Official title: Prospective, Single-Arm, Cohort Study on Basivertebral Nerve Ablation With the Intracept Procedure
This is an independent prospective, noninterventional, single arm post market data collection of the patient-reported effectiveness, ongoing safety, and satisfaction outcomes for patients treated with intraosseous basivertebral nerve ablation using the Intracept Procedure at a single study site.
Read the detailed description
Participants in the study will have three study visits over a period of one-year (one prior to procedure and 2 post their procedure). Study visits will be conducted in person by the principal investigator and/or authorized and trained clinical research coordinators at the study site. Participants will be consented and evaluated for inclusion/exclusion criteria and a baseline collect at the initial visit (prior to procedure). Participants will be followed post intraosseous basivertebral nerve ablation at 1, 3, 6, and 12, and 24 months.
Primary and secondary objectives are based on patient reported outcomes for functional improvement (Oswestry Disability Index), low back pain reduction (Visual Analog Scale), and physical and mental health pre and post procedure (EQ-5D-5L and SF-36).
- Conditions
- Low Back Pain
- Being tested
- Intracept Procedure
- Keywords
- Basivertebral nerve radiofrequency ablation, Chronic low back pain, Vertebrogenic pain
- 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 ProcedureDevice
Intraosseous radiofrequency ablation of the basivertebral nerve
| Study group | Role | What they receive |
|---|---|---|
| Basivertebral Nerve Ablation | Other | Intraosseous radiofrequency basivertebral nerve ablation Receives: Device: Intracept Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI) Change- 6 Months
Validated questionnaire of low back pain related disability. Compromised 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 6 months.
Measured: 6 Months
Secondary outcomes (7)
Oswestry Disability Index (ODI) Change-12 Months
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 6 months. The minimally clinically important difference is a 15-point reduction from baseline.
Measured: 12 Months
Visual Analog Scale (VAS)- 6 Months
Change in the mean visual analog scale (VAS) low back pain score from baseline to 6-months post treatment. VAS in a 10-point numeric scale with a 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference is a 50% decrease in VAS from baseline.
Measured: 6 Months
Visual Analog Scale (VAS)- 12 Months
Change in the mean visual analog scale (VAS) low back pain score from baseline to 12-months post treatment. VAS is a 10-point numeric scale with 0 being no pain and 10 being worst imaginable pain. The minimally clinically important difference is a 50% decrease in VAS from baseline.
Measured: 12 Months
ODI Responder Rate- 6 Months
Number \& percent of patients with greater than or equal to 15-point reduction in Oswestry Disability Index (ODI) from baseline to 6 months post treatment. ODI is scored on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimally disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). The minimally clinically important difference is a 15-point reduction from baseline.
Measured: 6 Months
ODI Responder Rate- 12 Months
Number \& percent of patients with greater than or equal to 15-point reduction in Oswestry Disability Index (ODI) from baseline to 12 months post treatment. ODI is scored on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimally disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). The minimally clinically important difference is a 15-point reduction from baseline.
Measured: 12 Months
VAS Responder Rate- 6 Months
Number and percentage of participants with a greater than or equal to a 50% reduction from baseline in visual analog scale (VAS) for low back pain at 6 months post treatment. VAS is a patient-reported 10-point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimally clinically important difference in VAS from baseline is a 50% reduction.
Measured: 6 Months
VAS Responder Rate-12 Months
Number and percentage of participants with a greater than or equal to a 50% reduction from baseline in visual analog scale (VAS) for low back pain at 12 months post treatment. VAS is a patient-reported 10-point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 50% reduction.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start3 May 2021
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group assignment
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuro Spine and Pain Center of Key West
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Schnapp, PhD, Principal investigator, Owner
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692440
- Sponsor's protocol ID
- 20223348
- Status last verified
- Mar 2024
- First submitted
- 11 Jan 2023
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Schnapp W, Schnapp M, Gottlieb J, Alexandre LC, Martiatu K, Delcroix GJ. Prospective cohort study of basivertebral nerve ablation for chronic low back pain in a real-world setting: 12 months follow-up. Interv Pain Med. 2024 Nov 25;3(4):100446. doi: 10.1016/j.inpm.2024.100446. eCollection 2024 Dec.
PubMed 39655088
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-Arm, Cohort Study on Basivertebral Nerve Ablation With the Intracept Procedure
- ClinicalTrials.gov ID
- NCT05692440
- Acronym / sponsor ID
- 20223348
- Conditions
- Low Back Pain
- Keywords
- Basivertebral nerve radiofrequency ablation, Chronic low back pain, Vertebrogenic pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Neuro Spine and Pain Center of Key WestUniversity, hospital or other
- Study start
- 3 May 2021 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 20 Jan 2023 (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.
This is an independent prospective, noninterventional, single arm post market data collection of the patient-reported effectiveness, ongoing safety, and satisfaction outcomes for patients treated with intraosseous basivertebral nerve ablation using the Intracept Procedure at a single study site.
Detailed description
Participants in the study will have three study visits over a period of one-year (one prior to procedure and 2 post their procedure). Study visits will be conducted in person by the principal investigator and/or authorized and trained clinical research coordinators at the study site. Participants will be consented and evaluated for inclusion/exclusion criteria and a baseline collect at the initial visit (prior to procedure). Participants will be followed post intraosseous basivertebral nerve ablation at 1, 3, 6, and 12, and 24 months.
Primary and secondary objectives are based on patient reported outcomes for functional improvement (Oswestry Disability Index), low back pain reduction (Visual Analog Scale), and physical and mental health pre and post procedure (EQ-5D-5L and SF-36).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group assignment
| Arm | Type | Receives |
|---|---|---|
| Basivertebral Nerve Ablation | Other | Device: Intracept ProcedureIntraosseous radiofrequency basivertebral nerve ablation |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients ≥18 years of age
- Patients who have experienced chronic low back pain for ≥6 months.
- Patients who have not responded to at least 6 months of conservative care.
- Patients with Modic type 1 or 2 changes.
Key exclusion criteria (2 listed)
- Patients with severe cardiac or pulmonary disease.
- Patients with active systemic infection or localized infection in the treatment area.
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 ProcedureIntraosseous radiofrequency ablation of the basivertebral nerve | Device | Basivertebral Nerve Ablation |
Primary outcome
Oswestry Disability Index (ODI) Change- 6 Months
Time frame: 6 Months
Validated questionnaire of low back pain related disability. Compromised 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 6 months.
7 secondary outcomes
Oswestry Disability Index (ODI) Change-12 Months
Time frame: 12 Months
Visual Analog Scale (VAS)- 6 Months
Time frame: 6 Months
Visual Analog Scale (VAS)- 12 Months
Time frame: 12 Months
ODI Responder Rate- 6 Months
Time frame: 6 Months
ODI Responder Rate- 12 Months
Time frame: 12 Months
VAS Responder Rate- 6 Months
Time frame: 6 Months
VAS Responder Rate-12 Months
Time frame: 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Derived from this study: PubMed 39655088Schnapp W, Schnapp M, Gottlieb J, Alexandre LC, Martiatu K, Delcroix GJ. Prospective cohort study of basivertebral nerve ablation for chronic low back pain in a real-world setting: 12 months follow-up. Interv Pain Med. 2024 Nov 25;3(4):100446. doi: 10.1016/j.inpm.2024.100446. eCollection 2024 Dec.
- 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.
William Schnapp, PhD principal investigator
Owner
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 Intracept Procedure in people with Low Back Pain, run by Neuro Spine and Pain Center of Key West 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 Mar 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.
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?
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) Change- 6 Months (time frame: 6 Months). 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 NCT05692440, 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 21 Mar 2024.