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Prospective Pilot Study of Painful Lumbar Facet Joint Arthropathy after Intra-articular Injection of Hylan G-F 20
PM&R, 11/02/09

DePalma ML et al. – 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.

Methods

Prospective, uncontrolled, pilot study.
Participants: 15 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).
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.
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), ODI, SF–36, FTF, and sitting tolerance 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 or walking 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 and increased slightly at 12 months (45%).

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