Medial Branch Radiofrequency Ablation and Lumbar Multifidi
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|ClinicalTrials.gov Identifier: NCT03744260|
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : December 10, 2019
|Condition or disease||Intervention/treatment|
|Spondylosis Osteoarthritis||Diagnostic Test: Patients undergo ultrasound and lumbar MRI|
|Study Type :||Observational|
|Estimated Enrollment :||12 participants|
|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|
|Actual Study Start Date :||January 1, 2017|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
- Diagnostic Test: Patients undergo ultrasound and lumbar MRI
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.
- 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.
- Score on Numeric Pain Rating Scale (NPRS) [ Time Frame: Up to 3 months after radiofrequency ablation procedure ]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").
- Percentage Score on the Modified Oswestry Disability Index [ Time Frame: Up to 3 months after radiofrequency ablation procedure ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03744260
|Contact: Clark C. Smith, MDfirstname.lastname@example.org|
|United States, New York|
|Columbia University Vagelos College of Physicians and Surgeons||Recruiting|
|New York, New York, United States, 10032|
|Contact: Will Douglas, MD 212-305-3535 email@example.com|
|Principal Investigator: Clark C Smith, MD|
|Sub-Investigator: Christopher Visco, MD|
|Sub-Investigator: Evan K Johnson, PhD|
|Principal Investigator:||Clark C. Smith, MD||Columbia University|