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. DESIGN: Prospective, uncontrolled, pilot study. SETTING: University spine center. PARTICIPANTS: 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. MAIN OUTCOME MEASURES: 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 Keywords : administration & dosage,Adult,Aged,analogs & derivatives,Back Pain,Biocompatible Materials,Female,Health Status Indicators,Humans,Hyaluronic Acid,Injections,Intra-Articular,Low Back Pain,Lumbar Vertebrae,Male,methods,Middle Aged,Pain,Pain Measurement,Patient Satisfaction,Pilot Projects,Prospective Studies,rehabilitation,Sample Size,Spine,Treatment Outcome,Viscosupplementation,Walking,Zygapophyseal Joint,, Pilot,Study,Painful,Lumbar, how to breathe with diaphragm
Date of Publication : 2009 Oct
Authors : DePalma MJ;Ketchum JM;Queler ED;Trussell BS;
Organisation : VCU Spine Center, Virginia Commonwealth University Department of Physical Medicine and Rehabilitation, Richmond, VA 23235, USA. depalmamj8@yahoo.com
Journal of Publication : PM R
Pubmed Link : https://www.ncbi.nlm.nih.gov/pubmed/19854419
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