Arthritis;LumbosacralNCT03631030
Cooled RF Lesion MRI Characteristics
A study testing Cooled radiofrequency ablation in people with Arthritis;Lumbosacral and Osteo Arthritis Knee, run by International Spine, Pain and Performance Center at 2 sites in United States.
Trial summary
This Prospective, Single-center, Pilot Study will assist in gaining an understanding of the actual CRFA lesions in an in vivo situation in areas where CRFA is utilized as a standard of care treatment option for the relief of chronic pain (cervical facet joints, thoracic facet joints, lumbar facet joints, Sacroiliac… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthritis;Lumbosacral, Osteo Arthritis Knee, Sacroiliitis
- What is being tested?
- Cooled radiofrequency ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Feb 2018to Jan 2020
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 21 years
- Able to understand the informed consent form and provide written informed consent and able to complete outcome measures.
- Must be clinically appropriate candidate to receive CRFA for treatment of chronic pain.
- Willing and able to receive an MRI
Who cannot join
- Unable to receive an MRI (i.e. due to pacemaker or iron-based metal implant).
- Unable to receive an MRI (i.e. iron-based metal implant).
- Extremely thin patients and those with minimal subcutaneous tissue thickness that would not accommodate a radiofrequency lesion of up to 14mm in diameter to limit the risk of skin burns.
- Active joint infection or systemic or localized infection at the needle entry site (subject may be considered for inclusion once infection is resolved.)
- Subject currently implanted with a pacemaker or defibrillator
- In the event a pre-treatment MRI is obtained; trauma or injury occurring to the targeted area between the baseline MRI and CRFA treatment
- Subject unwillingness or unable to comply with protocol requirements
Trial locations and contacts
2 sites in 1 country.
United States2 sites
International Spine, Pain and Performance Center
Arlington, Virginia, 22205
International Spine, and Performance Center
Washington D.C., District of Columbia, 20037
About this study
Official title: A Prospective, Single-center, Pilot Study of in Vivo Lesion Characteristics Post Coolief Cooled Radiofrequency Denervation as a Treatment for Chronic Pain
This Prospective, Single-center, Pilot Study will assist in gaining an understanding of the actual CRFA lesions in an in vivo situation in areas where CRFA is utilized as a standard of care treatment option for the relief of chronic pain (cervical facet joints, thoracic facet joints, lumbar facet joints, Sacroiliac (SI) region, hip and knee).
Read the detailed description
This study will be a prospective, single-center, pilot study. Adult subjects over the age 21 diagnosed with chronic joint pain (≥ 3 months), scheduled to receive Radiofrequency denervation and meet the selection criteria are eligible to participate in this study. The specific targeted areas of interest in this study will include Cervical facet joints, Thoracic facet joints, Lumbar facet joints, Sacroiliac (SI) region, hip and knee.
The treating physician will follow Standard of Care treatment for all enrolled subjects. As illustrated in Figure 1, the study consists of a screening visit, a treatment visit and a follow up visit. All subjects receiving CRFA will receive an MRI 2 - 7 days after the CRFA procedure. Subjects receiving CRFA of the Sacroiliac Joint will also receive an MRI within 30 days prior to the CRFA procedure. The treating physician may also request an MRI be performed prior to the procedure for subjects receiving CRFA of other targeted areas. The point of enrollment for each subject is the time that they sign the Informed Consent Form.
MRI data will be reviewed by the radiologist on a per patient basis to confirm lesion characteristics. It is anticipated that 3-5 subjects per level will be needed to fully quantify lesion characteristics, however; enrollment will remain flexible for each targeted area based on real time review of MRI data.
- Conditions
- Arthritis;Lumbosacral, Osteo Arthritis Knee, Sacroiliitis, Hip Osteoarthritis, Arthritis, Degenerative
- Being tested
- Cooled radiofrequency ablation
- Keywords
- Cooled radiofrequency ablation, MRI
- Medical subject headings
- Sacroiliitis, Osteoarthritis, Hip, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooled radiofrequency ablationDevice
Cooled Radiofrequency ablation (CRFA) is a well-established method for delivering lesions into nervous tissue to accomplish neurotomy procedures
| Study group | Role | What they receive |
|---|---|---|
| Cooled radiofrequency ablation | Other | This is a single arm study. Patients who will be undergoing cooled radiofrequency ablation for the treatment of arthritis in the cervical facet joints, thoracic facet joints, lumbar facet joints, sacroiliac (SI) region, hip and knee. Receives: Device: Cooled radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cooled radiofrequency ablation lesion size
Size in millimeters of cooled radiofrequency ablation lesion via MRI
Measured: MRI obtained between 2-7 days post-procedure.
Secondary outcomes (1)
Pain relief
Compare pre-procedure and post-procedure change in pain using the numerical pain rating scale with 0 being no pain and 10 being the worst possible pain.
Measured: 2-4 weeks post-procedure as compared to pre-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start25 Feb 2018
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Arthritis;LumbosacralStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, singe group cohort study
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Spine, Pain and Performance Center
- Sponsor type
- University, hospital or other
- Collaborators
- Halyard Health
- Responsible party
- Sponsor
- Investigators
- Mehul Desai, MD, MPH, Principal investigator, International Spine Pain & Performance Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631030
- Sponsor's protocol ID
- 105-17-0004
- Status last verified
- Aug 2019
- First submitted
- 5 Mar 2018
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kapural L, Stojanovic M, Sessler DI, Bensitel T, Zovkic P. Cooled radiofrequency (RF) of L5 dorsal ramus for RF denervation of the sacroiliac joint: technical report. Pain Med. 2010 Jan;11(1):53-7. doi: 10.1111/j.1526-4637.2009.00772.x. Epub 2009 Dec 16.
PubMed 20030745Patel N, Gross A, Brown L, Gekht G. A randomized, placebo-controlled study to assess the efficacy of lateral branch neurotomy for chronic sacroiliac joint pain. Pain Med. 2012 Mar;13(3):383-98. doi: 10.1111/j.1526-4637.2012.01328.x. Epub 2012 Feb 2.
PubMed 22299761Stelzer W, Aiglesberger M, Stelzer D, Stelzer V. Use of cooled radiofrequency lateral branch neurotomy for the treatment of sacroiliac joint-mediated low back pain: a large case series. Pain Med. 2013 Jan;14(1):29-35. doi: 10.1111/pme.12014. Epub 2012 Dec 28.
PubMed 23279364Ho KY, Hadi MA, Pasutharnchat K, Tan KH. Cooled radiofrequency denervation for treatment of sacroiliac joint pain: two-year results from 20 cases. J Pain Res. 2013 Jul 4;6:505-11. doi: 10.2147/JPR.S46827. Print 2013.
PubMed 23869175Kapural L, Mekhail N. Novel intradiscal biacuplasty (IDB) for the treatment of lumbar discogenic pain. Pain Pract. 2007 Jun;7(2):130-4. doi: 10.1111/j.1533-2500.2007.00120.x.
PubMed 17559482Karaman H, Tufek A, Kavak GO, Kaya S, Yildirim ZB, Uysal E, Celik F. 6-month results of TransDiscal Biacuplasty on patients with discogenic low back pain: preliminary findings. Int J Med Sci. 2010 Dec 14;8(1):1-8. doi: 10.7150/ijms.8.1.
PubMed 21197258Kapural L, Vrooman B, Sarwar S, Krizanac-Bengez L, Rauck R, Gilmore C, North J, Girgis G, Mekhail N. A randomized, placebo-controlled trial of transdiscal radiofrequency, biacuplasty for treatment of discogenic lower back pain. Pain Med. 2013 Mar;14(3):362-73. doi: 10.1111/pme.12023. Epub 2012 Dec 28.
PubMed 23279658
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Pilot Study of in Vivo Lesion Characteristics Post Coolief Cooled Radiofrequency Denervation as a Treatment for Chronic Pain
- ClinicalTrials.gov ID
- NCT03631030
- Acronym / sponsor ID
- 105-17-0004
- Conditions
- Arthritis;Lumbosacral, Osteo Arthritis Knee, Sacroiliitis, Hip Osteoarthritis, Arthritis, Degenerative
- Keywords
- Cooled radiofrequency ablation, MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- International Spine, Pain and Performance CenterUniversity, hospital or other
- Collaborators
- Halyard Health
- Study start
- 25 Feb 2018 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 15 Aug 2018 (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 Prospective, Single-center, Pilot Study will assist in gaining an understanding of the actual CRFA lesions in an in vivo situation in areas where CRFA is utilized as a standard of care treatment option for the relief of chronic pain (cervical facet joints, thoracic facet joints, lumbar facet joints, Sacroiliac (SI) region, hip and knee).
Detailed description
This study will be a prospective, single-center, pilot study. Adult subjects over the age 21 diagnosed with chronic joint pain (≥ 3 months), scheduled to receive Radiofrequency denervation and meet the selection criteria are eligible to participate in this study. The specific targeted areas of interest in this study will include Cervical facet joints, Thoracic facet joints, Lumbar facet joints, Sacroiliac (SI) region, hip and knee.
The treating physician will follow Standard of Care treatment for all enrolled subjects. As illustrated in Figure 1, the study consists of a screening visit, a treatment visit and a follow up visit. All subjects receiving CRFA will receive an MRI 2 - 7 days after the CRFA procedure. Subjects receiving CRFA of the Sacroiliac Joint will also receive an MRI within 30 days prior to the CRFA procedure. The treating physician may also request an MRI be performed prior to the procedure for subjects receiving CRFA of other targeted areas. The point of enrollment for each subject is the time that they sign the Informed Consent Form.
MRI data will be reviewed by the radiologist on a per patient basis to confirm lesion characteristics. It is anticipated that 3-5 subjects per level will be needed to fully quantify lesion characteristics, however; enrollment will remain flexible for each targeted area based on real time review of MRI data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, singe group cohort study
| Arm | Type | Receives |
|---|---|---|
| Cooled radiofrequency ablation | Other | Device: Cooled radiofrequency ablationThis is a single arm study. Patients who will be undergoing cooled radiofrequency ablation for the treatment of arthritis in the cervical facet joints, thoracic facet joints, lumbar facet joints, sacroiliac (SI) region, hip and knee. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 21 years
- Able to understand the informed consent form and provide written informed consent and able to complete outcome measures.
- Must be clinically appropriate candidate to receive CRFA for treatment of chronic pain.
- Willing and able to receive an MRI
Key exclusion criteria (7 listed)
- Unable to receive an MRI (i.e. due to pacemaker or iron-based metal implant).
- Unable to receive an MRI (i.e. iron-based metal implant).
- Extremely thin patients and those with minimal subcutaneous tissue thickness that would not accommodate a radiofrequency lesion of up to 14mm in diameter to limit the risk of skin burns.
- Active joint infection or systemic or localized infection at the needle entry site (subject may be considered for inclusion once infection is resolved.)
- Subject currently implanted with a pacemaker or defibrillator
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 |
|---|---|---|
| Cooled radiofrequency ablationCooled Radiofrequency ablation (CRFA) is a well-established method for delivering lesions into nervous tissue to accomplish neurotomy procedures | Device | Cooled radiofrequency ablation |
Primary outcome
Cooled radiofrequency ablation lesion size
Time frame: MRI obtained between 2-7 days post-procedure.
Size in millimeters of cooled radiofrequency ablation lesion via MRI
1 secondary outcome
Pain relief
Time frame: 2-4 weeks post-procedure as compared to pre-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Background: PubMed 20030745Kapural L, Stojanovic M, Sessler DI, Bensitel T, Zovkic P. Cooled radiofrequency (RF) of L5 dorsal ramus for RF denervation of the sacroiliac joint: technical report. Pain Med. 2010 Jan;11(1):53-7. doi: 10.1111/j.1526-4637.2009.00772.x. Epub 2009 Dec 16.
- Background: PubMed 22299761Patel N, Gross A, Brown L, Gekht G. A randomized, placebo-controlled study to assess the efficacy of lateral branch neurotomy for chronic sacroiliac joint pain. Pain Med. 2012 Mar;13(3):383-98. doi: 10.1111/j.1526-4637.2012.01328.x. Epub 2012 Feb 2.
- Background: PubMed 23279364Stelzer W, Aiglesberger M, Stelzer D, Stelzer V. Use of cooled radiofrequency lateral branch neurotomy for the treatment of sacroiliac joint-mediated low back pain: a large case series. Pain Med. 2013 Jan;14(1):29-35. doi: 10.1111/pme.12014. Epub 2012 Dec 28.
- Background: PubMed 23869175Ho KY, Hadi MA, Pasutharnchat K, Tan KH. Cooled radiofrequency denervation for treatment of sacroiliac joint pain: two-year results from 20 cases. J Pain Res. 2013 Jul 4;6:505-11. doi: 10.2147/JPR.S46827. Print 2013.
- Background: PubMed 17559482Kapural L, Mekhail N. Novel intradiscal biacuplasty (IDB) for the treatment of lumbar discogenic pain. Pain Pract. 2007 Jun;7(2):130-4. doi: 10.1111/j.1533-2500.2007.00120.x.
- Background: PubMed 21197258Karaman H, Tufek A, Kavak GO, Kaya S, Yildirim ZB, Uysal E, Celik F. 6-month results of TransDiscal Biacuplasty on patients with discogenic low back pain: preliminary findings. Int J Med Sci. 2010 Dec 14;8(1):1-8. doi: 10.7150/ijms.8.1.
- Background: PubMed 23279658Kapural L, Vrooman B, Sarwar S, Krizanac-Bengez L, Rauck R, Gilmore C, North J, Girgis G, Mekhail N. A randomized, placebo-controlled trial of transdiscal radiofrequency, biacuplasty for treatment of discogenic lower back pain. Pain Med. 2013 Mar;14(3):362-73. doi: 10.1111/pme.12023. Epub 2012 Dec 28.
- Individual participant dataSharing planned: No
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.
Mehul Desai, MD, MPH principal investigator
International Spine Pain & Performance Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooled radiofrequency ablation in people with Arthritis;Lumbosacral and Osteo Arthritis Knee, run by International Spine, Pain and Performance Center at 2 sites 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 7 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 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Cooled radiofrequency ablation lesion size (time frame: MRI obtained between 2-7 days 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 NCT03631030, which also lists 7 linked publications.
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 7 Aug 2019.