Medial Branch Blocks vs. Intra-articular Injections: Randomized, Controlled Study

Two hundred and twenty five patients with suspected lumbar facet arthropathy scheduled to
undergo diagnostic lumbar facet blocks will be enrolled in this study at WRNMMC and
randomized in a 2:2:1 ratio into one of 3 groups. Group 1 will receive IA blocks with
steroids and LA, group 2 will receive MBB with steroids and LA, and group 3 will receive MBB
with only saline. Subjects and (but not injecting physicians) evaluators will be blinded
throughout their participation in the study as to treatment allocation. The nerves and joints
to be blocked will be determined by physical exam (i.e. the location of paraspinal
tenderness), and radiological findings.

Group 1: The 80 patients in this group will undergo IA blocks under fluoroscopic guidance
with 0.5 mL solutions containing a 50:50 mixture of 0.5% bupivacaine and 10 mg
depomethylprednisolone (called "steroid"). In all cases, correct positioning will be
confirmed by the administration of contrast. After the block, they will be administered a
pain diary to maintain for the next 6 hours. In accordance with standard care, a positive
response will be > 50% pain relief lasting at least 3 hours. Patients who have not undergone
physical therapy (PT) will be sent for PT . The first follow-up will be at 1-month. In those
individuals with a positive block whose pain has returned to baseline, RF denervation will be
performed at the same levels done for the diagnostic block. Once adequate sensory stimulation
is confirmed, a 1 mL mixture containing equal amounts of 2% lidocaine 0.5 mL) and 20 mg
depo-methylprednisolone (0.5 mL) will be injected to reduce procedure-related pain and
decrease the incidence of neuritis. For those patients who have persistent (> 50%) pain
relief at 1-month, they will return for their 2nd follow-up at 3-months. If their pain relief
persists at this point, their final follow-up will be 6-months post-procedure. Pain relief in
this group that lasts > 6 months can be treated with repeat IA injections if the patient so
desires, while that which persists for < 6 months will be treated with RF denervation.
Patients who experience a negative diagnostic block, or who fail to obtain significant pain
relief at any follow-up from their RF denervation, will exit the study per protocol to pursue
alternative treatments

Group 2: The 80 patients in this group will undergo MBB blocks under fluoroscopic guidance
with 0.5 mL solutions containing a 50:50 mixture of 0.5% bupivacaine and 10 mg of
depo-methylprednisolone steroid. After the block, they will be administered a pain diary to
maintain for the next 6 hours. Patients who have not undergone physical therapy will be sent
for a PT program. The first follow-up will be at 1-month. In those individuals who do not
experience significant pain relief, RF denervation will be performed at the same levels done
for the diagnostic block, as described in 'Group 1'. For those patients who have persistent
(> 50%) pain relief at 1-month, they will return for their 2nd follow-up at 3-months. If
their pain relief persists at this point, their final follow-up will be 6-months
post-procedure. Pain relief in this group that lasts > 6 months can be treated with repeat
MBB if they desire, while that which persists for < 6 months will be treated with RF
denervation. Patients who experience a negative diagnostic block, or who fail to obtain
significant pain relief at any follow-up from their RF denervation, will exit the study per
protocol to pursue alternative treatments.

Group 3: The 40 patients in this group will undergo IA blocks under fluoroscopic guidance
with 0.5 mL of normal saline. After the block, they will be administered a pain diary to
maintain for the next 6 hours. Patients who have not undergone physical therapy will be sent
for PT. The first follow-up will be at 1-month. In those individuals who fail to experience
significant pain relief at this time point, RF denervation will be performed at the same
levels done for the diagnostic block, as described in 'Group 1'. For those patients who have
persistent (> 50%) pain relief at 1-month, they will return for their 2nd follow-up at
3-months. If their pain relief persists at this point, their final follow-up will be 6-months
post-procedure. Pain relief from the block in this group that lasts > 6 months can be treated
with repeat MBB, while that which persists for < 6 months will be treated with RF
denervation. In patients who do not experience significant pain relief at their 1-month
follow-up, RF denervation will be performed. Those who experience a negative outcome from RF
denervation, will exit the study per protocol to pursue alternative treatments.

During follow visits, subjects who have difficulty arranging for transportation can elect to
conduct their follow-up visits over the telephone, via fax, or by e-mail, whichever is most
convenient.

Inclusion Criteria:

- Age > 18 years

- Suspected lumbar facet arthropathy based on history and physical exam (e.g. axial
lower back pain, paraspinal tenderness, no pain referral below the knee)

- NRS back pain score > 4;

- MRI evidence of spinal pathology consistent with symptoms.

Exclusion Criteria:

- Untreated coagulopathy

- No MRI study

- Signs or symptoms of cauda equina syndrome

- Focal neurological signs and symptoms

- Allergic reactions to local anesthetics or contrast dye

- Serious medical or condition that might preclude optimal outcome

- Pregnancy