SpondylosisNCT03744260
Medial Branch Radiofrequency Ablation and Lumbar Multifidi
An observational study of Spondylosis and Osteoarthritis, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of lumbar medial branch radiofrequency ablation (RFA) on lumbar multifidi muscle size and clinical spinal stability. Specifically, this study is designed to highlight the comparison of multifidi muscle architecture using ultrasound imaging (USI) and MRI before and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondylosis, Osteoarthritis
- What is being tested?
- Patients undergo ultrasound and lumbar MRI
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to 30 Jun 2020
- 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: People with back pain caused by osteoarthritis or degeneration of the facet joint.
Who may be able to join
- Aged over 18 years
- Presence of lumbar spondylosis or facet arthropathy (as determined by a radiologist) *Unilateral back pain without radicular symptoms
- Positive physical findings for facet mediated pain (pain with lumbar extension and rotation to affected side)
- Ability to complete outcome measure forms.
Who cannot join
- Prior spinal surgery
- Prior RFA procedures
- Pregnancy
- Contraindications to MRI
- Presence of therapeutic anti-coagulation, medical co-morbidities that would interfere with the ability to perform the procedure safely
- Presence of neurologic changes
Show all 9Show fewer
- Active tobacco smoking history
- Presence of active litigation
- Presence of open workers compensation case
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Vagelos College of Physicians and Surgeons
New York, New York, 10032
About this study
Official title: The Effect of Medial Branch Radiofrequency Ablation on Functional Spinal Stability and Lumbar Multifidi Muscle Architecture Assessed by Magnetic Resonance Imaging and Ultrasound Imaging
The purpose of this study is to evaluate the effects of lumbar medial branch radiofrequency ablation (RFA) on lumbar multifidi muscle size and clinical spinal stability. Specifically, this study is designed to highlight the comparison of multifidi muscle architecture using ultrasound imaging (USI) and MRI before and after lumbar medial branch RFA. This study will also include a commonly utilized functional assessment of the lumbar spine to evaluate the effects of RFA on lumbar spinal stability.
Read the detailed description
Radiofrequency ablation (RFA) for the lumbar spine (lower back) is a procedure used to treat lower back pain secondary to facet arthritis. The procedure ablates (burns) a small nerve that goes to the arthritic joint in the back. This nerve also innervates a muscle called the multifidus, thought to be important for lumbar stability. The investigators are conducting a study to evaluate if RFA has any impact on multifidi size, spinal stability, and overall function. The tools the investigators will be using to assess the multifidi muscles are musculoskeletal ultrasound, MRI, physical therapy assessment, and functional questionnaires. The goal of the study is to determine if RFA impacts the multifidi in a clinically significant fashion, causing atrophy, spinal instability, and/or functional decline.
- Conditions
- Spondylosis, Osteoarthritis
- Being tested
- Patients undergo ultrasound and lumbar MRI
- Keywords
- Lower back pain, Radiofrequency ablation, Spine
- Medical subject headings
- Spondylosis, Osteoarthritis, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients undergo ultrasound and lumbar MRIDiagnostic test
Patients undergo ultrasound, physical therapy exam and MRI before and after the radiofrequency ablation procedure that they are getting as part of their regular care.
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Volume of multifidus muscle on MRI
Analysis will include volumetric measurements of the multifidi as well as volumetric assessments of the muscle with fat subtracted.
Measured: Up to 3 months after radiofrequency ablation procedure
Percentage Change in Cross Sectional Area of Multifidi
Area will be measured by MRI scan.
Measured: Up to 3 months after radiofrequency ablation procedure
Secondary outcomes (2)
Score on Numeric Pain Rating Scale (NPRS)
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults. Respondents are asked to select a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Measured: Up to 3 months after radiofrequency ablation procedure
Percentage Score on the Modified Oswestry Disability Index
This is a patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain. It examines perceived level of disability in 10 everyday activities of daily living, which each statement scored from 0 (no disability) to 5 (worst pain). An aggregate score (percentage) is then calculated, with 0% indicating no disability to 100%, indicating crippled or bed-bound.
Measured: Up to 3 months after radiofrequency ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start1 Jan 2017
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondylosisStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clark Smith, Columbia University
- Investigators
- Clark C. Smith, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744260
- Sponsor's protocol ID
- AAAR1440
- Status last verified
- Jul 2020
- First submitted
- 14 Nov 2018
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Medial Branch Radiofrequency Ablation on Functional Spinal Stability and Lumbar Multifidi Muscle Architecture Assessed by Magnetic Resonance Imaging and Ultrasound Imaging
- ClinicalTrials.gov ID
- NCT03744260
- Acronym / sponsor ID
- AAAR1440
- Conditions
- Spondylosis, Osteoarthritis
- Keywords
- Lower back pain, Radiofrequency ablation, Spine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 16 Nov 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.
The purpose of this study is to evaluate the effects of lumbar medial branch radiofrequency ablation (RFA) on lumbar multifidi muscle size and clinical spinal stability. Specifically, this study is designed to highlight the comparison of multifidi muscle architecture using ultrasound imaging (USI) and MRI before and after lumbar medial branch RFA. This study will also include a commonly utilized functional assessment of the lumbar spine to evaluate the effects of RFA on lumbar spinal stability.
Detailed description
Radiofrequency ablation (RFA) for the lumbar spine (lower back) is a procedure used to treat lower back pain secondary to facet arthritis. The procedure ablates (burns) a small nerve that goes to the arthritic joint in the back. This nerve also innervates a muscle called the multifidus, thought to be important for lumbar stability. The investigators are conducting a study to evaluate if RFA has any impact on multifidi size, spinal stability, and overall function. The tools the investigators will be using to assess the multifidi muscles are musculoskeletal ultrasound, MRI, physical therapy assessment, and functional questionnaires. The goal of the study is to determine if RFA impacts the multifidi in a clinically significant fashion, causing atrophy, spinal instability, and/or functional decline.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with back pain caused by osteoarthritis or degeneration of the facet joint.
Key inclusion criteria (4 listed)
- Aged over 18 years
- Presence of lumbar spondylosis or facet arthropathy (as determined by a radiologist) *Unilateral back pain without radicular symptoms
- Positive physical findings for facet mediated pain (pain with lumbar extension and rotation to affected side)
- Ability to complete outcome measure forms.
Key exclusion criteria (9 listed)
- Prior spinal surgery
- Prior RFA procedures
- Pregnancy
- Contraindications to MRI
- Presence of therapeutic anti-coagulation, medical co-morbidities that would interfere with the ability to perform the procedure safely
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 |
|---|---|---|
| Patients undergo ultrasound and lumbar MRIPatients undergo ultrasound, physical therapy exam and MRI before and after the radiofrequency ablation procedure that they are getting as part of their regular care. | Diagnostic test | – |
Primary outcome
Percentage Change in Volume of multifidus muscle on MRI
Time frame: Up to 3 months after radiofrequency ablation procedure
Analysis will include volumetric measurements of the multifidi as well as volumetric assessments of the muscle with fat subtracted.
Percentage Change in Cross Sectional Area of Multifidi
Time frame: Up to 3 months after radiofrequency ablation procedure
Area will be measured by MRI scan.
2 secondary outcomes
Score on Numeric Pain Rating Scale (NPRS)
Time frame: Up to 3 months after radiofrequency ablation procedure
Percentage Score on the Modified Oswestry Disability Index
Time frame: Up to 3 months after radiofrequency ablation procedure
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 10 Jul 2020.
- 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.
Clark C. Smith, MD principal investigator
Columbia University
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 Spondylosis and Osteoarthritis, run by Columbia University 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 9 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 10 Jul 2020. 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?
Percentage Change in Volume of multifidus muscle on MRI (time frame: Up to 3 months after radiofrequency ablation procedure). The study lists 2 primary outcomes in all. 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 10 Jul 2020.