Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
DePuy Spine
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Persistent low back pain, with at least 3 months of non-surgical therapy, at one symptomatic lumbar level (L3/L4 to L5/S1) as confirmed using a standardized discography protocol
2. Oswestry Disability Index of 30 or greater
3. Low back pain score greater than or equal to 4 cm as measured by VAS, at Visit 1 baseline and on day of treatment to confirm eligibility prior to administration
You may not be if
1. Persons unable to have a discogram, CT or an MRI
2. Abnormal neurological exam at baseline (e.g., radiculopathy)
3. Radicular pain
4. Leak of contrast agent during the discogram, into the epidural space (does not include leak of contrast agent along the needle track)
5. MRI findings demonstrate any of the following:· Suspected disc appears normal· \>50% decrease in disc height· Modic changes, and/or· Presence of osteophytes or significant facet arthrosis
Clareo Health | Intradiscal rhGDF-5 Phase I/II Clinical Trial
