In an international, randomized, double-blind, parallel-group study, patients classified C0s to C4 according to Clinical Etiological Anatomic Pathophysiologic [CEAP] classification and with leg pain graded as superior to 4 cm on a 10-cm visual analog scale (VAS), were treated for 8 weeks with either MPFF 1000 mg once daily or MPFF 500 mg twice daily.
Patient-reported back and leg pain using the visual analog scale (VAS) and opioid dose (milligrams morphine equivalent/day, MME/day) were compared at 12 months post-10 kHz SCS therapy to baseline.
At 24 months there was no significant difference between clinical outcomes of the β-TCP or rhBMP-2 patients, with improvements in back pain (46% and 49%; P = 0.98), leg pain (31 and 52%; P = 0.14), ODI (38 and 41%; P = 0.81), SF-36 PCS (37 and 38%; P = 0.87), and SF-36 MCS (8 and 8%; P = 0.93).
Multimodality imaging, including MRI, bone scintigraphy, and FDG PET/CT, was performed to evaluate a 49-year-old man who had right hip and lower limb pain for 4 months because possible malignancy was suspected.
Patients with MOD 1-3 were as likely as patients without MOD changes to be treatment-responders at W6 in terms of VAS leg pain, ODI, RMDI, TUG, EQ5D, and SF-12 PCS.