Discogenic Low Back Pain Registry
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|ClinicalTrials.gov Identifier: NCT04652687|
Recruitment Status : Recruiting
First Posted : December 3, 2020
Last Update Posted : January 25, 2023
|Condition or disease||Intervention/treatment|
|Discogenic Pain Low Back Pain||Biological: VIA Disc NP Drug: Transforaminal Epidural steroid injection Behavioral: Lifestyle modification Other: Physical therapy|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1000 participants|
|Target Follow-Up Duration:||36 Months|
|Official Title:||Discogenic Low Back Pain Registry|
|Actual Study Start Date :||May 3, 2020|
|Estimated Primary Completion Date :||December 2026|
|Estimated Study Completion Date :||July 2027|
VIA Disc NP
Patients meeting study criteria receiving Vivex VIA Disc NP injection as treatment for discogenic low back pain.
Biological: VIA Disc NP
VIA Disc NP - Allograft tissue injection
Non Surgical Management
Patients receiving non surgical management (i.e., physical therapy, transforaminal epidural steroid injection, lifestyle modification, or surgical intervention)
Drug: Transforaminal Epidural steroid injection
epidural injection of steroid into the affected area of low back pain
Behavioral: Lifestyle modification
physician instructed changes to patient's daily activities to alleviate low back pain
Other: Physical therapy
Physician ordered physical therapy and exercises to alleviate low back pain
- Patient self-reporting of overall health [ Time Frame: 1, 3, 6, 12, 24, & 36 months ]Change in scores from Patient Reported Outcomes Measurement Information System (PROMIS-10). 10-item questionnaire used to assess general domains of health and function, including overall physical health, mental health, social health, pain, fatigue and overall perceived quality of life.
- Patient self-reporting of daily function [ Time Frame: 1, 3, 6, 12, 24, & 36 months ]Change in scores from Oswestry Disability Index (ODI). An index comprising of ten categories of function to quantify disability due to low back pain.
- Patient self-reported back pain [ Time Frame: 1, 3, 6, 12, 24, & 36 months ]Change in Numeric Rating Scale (NRS) scores. Eleven point pain scale used for patient self-reporting of back pain, which ranges from 0 (no pain) to 10 (the worst pain imaginable).
- Employment Status [ Time Frame: 1, 3, 6, 12, 24, & 36 months ]Patient reported return to work - same or different capacity answers to employment questions will be assessed across time points and compared.
- Resource Utilization [ Time Frame: 1, 3, 6, 12, 24, & 36 months ]Patient reported assessment of healthcare and resources utilized questions to treat ongoing discogenic low back pain post treatment.
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): NCT04652687
|Contact: Alex McClellan, BSemail@example.com|
|Contact: Hunter Hallfirstname.lastname@example.org|
|Study Director:||Lisa Finstein, MHA||Vivex Biologics|