PM&R
Volume 1, Issue 10 , Pages 908-915, October 2009

Prospective Pilot Study of Painful Lumbar Facet Joint Arthropathy after Intra-articular Injection of Hylan G-F 20

  • Michael J. DePalma, MD

      Affiliations

    • VCU Spine Center, Virginia Commonwealth University Department of Physical Medicine and Rehabilitation, 870 Stony Point Parkway, Suite 260, Richmond, VA 23235†
    • Corresponding Author InformationAddress correspondence to: M.J.D.
    • ,
  • Jessica M. Ketchum, PhD

      Affiliations

    • Virginia Commonwealth University, Department of Biostatistics, Richmond, VA‡
    • ,
  • Evan D. Queler, MD

      Affiliations

    • Virginia Commonwealth University Spine Center, Department of Physical Medicine and Rehabilitation, Richmond, VA§
    • ,
  • Brian S. Trussell, MD

      Affiliations

    • Virginia Commonwealth University Spine Center, Department of Physical Medicine and Rehabilitation, Richmond, VA

Received 16 July 2009; accepted 17 September 2009.

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.

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  • † Disclosure: 1A, unexercised stock options in AOI Medical; 2A, AOI Medical, Kyphon/Medtronic, Stryker Interventional Spine, St. Jude Medical; 3A, Lilly; 7B, Genzyme Biosurgery grant to support Facet joint project and Stryker biotech grant to support intradiscal research project; 9, Volunteer ISIS Research Committee, NASS Conflict of Interest Review Panel, NASS Clinical Guidelines Committee, AAPM&R Fellowship Directory Work Group
  • ‡ Disclosure: nothing to disclose
  • § Disclosure: nothing to disclose
  •  Disclosure: nothing to disclose

 Disclosure Key can be found on the Table of Contents and at www.pmrjournal.org

 This project was funded by an investigator initiated grant awarded by Genzyme Biosurgery.

PII: S1934-1482(09)01364-1

doi:10.1016/j.pmrj.2009.09.008

PM&R
Volume 1, Issue 10 , Pages 908-915, October 2009

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