Back Pain Clinical Trial
Official title:
VIA Disc NP Registry 3.0
Registry is to observe and trend patterns of care and outcomes for patients treated with VIA Disc NP.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | January 1, 2027 |
Est. primary completion date | January 1, 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol 2. 18 years of age or older 3. Literate, able to speak and read English, and able to complete questionnaires independently 4. Subject received a VIA Disc NP injection with 1 or more levels within 90 days of the baseline visit. Exclusion Criteria: 1. Participant did not receive VIA Disc NP injection 2. Participant is pregnant (self-reported, no special study pregnancy testing needed). 3. Any contraindications as noted in the VIA Disc NP Instructions for Use |
Country | Name | City | State |
---|---|---|---|
United States | Premier Pain Solutions | Asheville | North Carolina |
United States | The Orthopedic Institute | Gainesville | Florida |
United States | The Denver Spine & Pain Institute | Greenwood Village | Colorado |
United States | Crystal Coast Pain Management | New Bern | North Carolina |
United States | Interventional Pain Specialists - Pain Clinic | Opelousas | Louisiana |
Lead Sponsor | Collaborator |
---|---|
VIVEX Biologics, Inc. | Moxie Clinical |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Numeric Pain Rating Scale (NPRS) | 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). | 1, 3, 6, 12, & 24 months | |
Primary | Oswestry Disability Index (ODI) | Change in scores from Oswestry Disability Index (ODI). An index comprising of ten categories of function to quantify disability due to back pain. | 1, 3, 6, 12, & 24 months | |
Primary | Patient Satisfaction | Patient reported assessment of treatment using 3 different types of questions regarding their experience with the procedure. | 1, 3, 6, 12, & 24 months | |
Primary | Pain Medication | The subject's pain medication history will be collected at the patient's baseline and follow-up visits. | 1, 3, 6, 12, & 24 months |
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