Clinical Trial: Synvisc Injections for Lumbar Facet Joint Pain

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Efficacy and Safety of Intra-Articular Synvisc Injections as Treatment of Painful Lumbar Facet Joint Arthrosis

Brief Summary: The objective of this investigation is to evaluate the safety and efficacy of viscosupplementation in treating symptomatic lumbar facet joint arthropathy. The intended use of the device (Synvisc) is to alleviate pain and improve function in patients with painful lumbar facet joint arthrosis by intra-articular injection into the involved joint.

Detailed Summary: Patients will enter the study once the putatively painful joint or joints have been confirmed by single blind, double local-comparative anesthetic blockade. The joint(s) suspected by historical features and physical examination will be injected under fluoroscopic guidance with contrast-enhancement confirming intra-articular placement. The initial injectate will be 1cc of 2% xylocaine. Single diagnostic lumbar facet joint injections carry a false positive rate of 38%. In order to maximize the specificity of the diagnostic injections a second 1cc injection of a longer-acting local anesthetic, 0.5% marcaine, will be performed on all patients reporting clinically significant pain reduction (> 75% VAS reduction from pre-injection baseline) within 10-15 minutes after the xylocaine injection. This second diagnostic injection will be completed upon return of the patient’s pain back to baseline (no sooner than 3 days after the initial diagnostic injection). A true positive response will be defined as > 50% VAS reduction after the second injection. Patients will then undergo 2 IA Synvisc injections into the painful facet joint(s). An initial IA injection of 1.0cc (or a volume, not to exceed 1.0cc, accepted by the joint upon reaching a capsular endpoint) of Synvisc (1cc, 10mg/ml) will be injected into the painful joint(s) 7 days after the second diagnostic injection after the baseline pain has returned. A 2nd injection will then be performed 10 days after the initial injection. A 3rd injection may be offered to patients not satisfied with the results obtained with the first 2 Synvisc injections. A 2.0cc vial of Synvisc per patient will be shipped including other trial materials to the investigator for implementation. A fluid dispenser connector will allow direct dispensation of 1.0cc of Synvisc from the pre-packaged 2.0cc unmarked vial. Outcome measurement tools will include Visual Analogue Scale, Oswestry Disability Questionnaire, SF-36, lumbar spine range of moti
Sponsor: Sheltering Arms Physical Rehabilitation Hospitals

Current Primary Outcome:

  • Visual Analogue Scale (VAS) for baseline pain (best, worst, average) and pain while walking
  • Oswestry Disability Questionnaire
  • Short Form 36-Item (SF-36)
  • Standing/walking tolerance (defined as time patient can sit for before pain level reaches baseline or distance walked before pain reaches baseline)


Original Primary Outcome:

  • Visual Analogue Scale for baseline pain (best, worst, average) and pain while walking,
  • Oswestry Disability Questionnaire,
  • SF-36,
  • Standing/walking tolerance (defined as time patient can sit for before pain level reaches baseline or distance walked before pain reaches baseline).


Current Secondary Outcome:

  • Analgesic usage
  • Lumbar range of motion
  • Patient satisfaction


Original Secondary Outcome:

  • Analgesic usage,
  • Lumbar range of motion,
  • Patient satisfaction.


Information By: Sheltering Arms Physical Rehabilitation Hospitals

Dates:
Date Received: May 12, 2006
Date Started: May 2006
Date Completion: May 2008
Last Updated: September 12, 2006
Last Verified: September 2006