Primary Outcome Measures:
- 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)
Secondary Outcome Measures:
- Analgesic usage
- Lumbar range of motion
- Patient satisfaction
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 motion (ROM), sitting and walking tolerance, analgesic usage, and patient satisfaction. Data will be collected at baseline, at 7-10 days after the second Synvisc injection, and at 1, 3, 6, and 12 month follow up (after the final Synvisc injection) visits. For example, patient X will undergo an initial 2 Synvisc injections and then be evaluated in the office 7 days later. If the patient experiences significant benefit, no other injections will be pursued. However, if a therapeutic benefit is achieved but is not satisfactory to the patient, a 3rd Synvisc injection will be performed within 3 days. A side effect and complications questionnaire will be completed by each patient within 30 minutes, 24 hours, and 72 hours after each injection (including diagnostic injections).
Purpose
