Prospective pilot study of painful lumbar facet joint arthropathy after intra-articular injection of hylan G-F 20.
OBJECTIVE
To examine changes in pain, disability, and medication usage over time from baseline to up to 12 months after facet joint injection of hylan G-F 20.


METHODS
Prospective, uncontrolled, pilot study.


METHODS
University spine center.


METHODS
Fifteen patients (12 females), mean age of 57 years (standard deviation = 12.5), with a median duration of low back pain of 24 months (interquartile range = 11-66).


METHODS
Patients who fulfilled inclusion criteria underwent diagnostic blocks with local comparative anesthetics at one unilateral facet joint (FJ). Those with a true positive response underwent 2 1.0-mL intra-articular hylan G-F 20 injections, 10 days apart, into the painful FJ. A third hylan G-F 20 injection was offered to patients dissatisfied with the results obtained with the first 2 injections.


METHODS
Visual analog scale (VAS) (average, standing, walking), Oswestry Disability Index (ODI), SF-36, finger to floor distance (FTF), tolerance (standing, sitting, walking), analgesic usage, and patient satisfaction collected at baseline, 7-10 days, and at 1-, 3-, 6-, and 12-months follow-up.


RESULTS
Repeated measures mixed-models indicated that VAS (average, standing, walking [P all < .005]), ODI (P = .029), SF-36 (P = .013), FTF (P = .032), and sitting tolerance (P = .020) all showed significant changes from baseline up to 6 months and were not sustained at 12 months; with the exception of the baseline to 12-month difference for FTF. There was not evidence of changes over time in standing (P = .085) or walking (P = .084) tolerance. Satisfaction initially increased from baseline (0%) to 7-10 days (64%) but declined over time (36% at 12 months). As compared with baseline (80%), analgesic usage decreased nominally over time showing significant decreases at 6 months (33%, P = .0253) and increased slightly at 12 months (45%).


CONCLUSIONS
Viscosupplementation for lumbar FJ arthropathy with hylan G-F 20 is associated with modest efficacy that predominately lasts up to 6 months. Limitations include a small sample size and lack of both a control and blinding. Larger, randomized, controlled studies are indicated to better clarify its clinical safety, efficacy, and utility.
VCU Spine Center, Virginia Commonwealth University Department of Physical Medicine and Rehabilitation, Richmond, VA 23235, USA. depalmamj8@yahoo.com
Michael J
MJ
DePalma
Jessica M
JM
Ketchum
Evan D
ED
Queler
Brian S
BS
Trussell
D000328:Adult; D000368:Aged; D001672:Biocompatible Materials / Q000008:administration & dosage*; D005260:Female; D006305:Health Status Indicators; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives*; D007270:Injections, Intra-Articular; D008159:Lumbar Vertebrae; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D017060:Patient Satisfaction; D010865:Pilot Projects; D011446:Prospective Studies; D016896:Treatment Outcome; D055676:Viscosupplementation; D021801:Zygapophyseal Joint
D001672:Biocompatible Materials; C049816:hylan; D006820:Hyaluronic Acid