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.
Efficacy and Safety of Intra-Articular Synvisc Injections as Treatment of Painful Lumbar Facet Joint Arthrosis.
Treatment, Non-Randomised, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study.
Primary Outcome Measures:
- Visual Analogue Scale (VAS) for baseline pain (best, worst, average) and pain while walking
- 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
Eligibility & Criteria
- Ages Eligible for Study: 30 Years and older
- Genders Eligible for Study: Both
- Accepts Healthy Volunteers: No
- Ongoing axial lumbar pain, greater than any lower limb pain if present, for > 3 months duration.
- No improvement despite 6-8 weeks of physical therapy (PT), oral nonsteroidal anti-inflammatory drugs (NSAIDs), relative rest, and activity modification.
- Radiographic evidence of facet joint arthrosis on advanced imaging studies defined as joint capsule hypertrophy, osteophyte formation, joint space narrowing, irregularity of joint contours, subchondral sclerosis, and synovial cyst formation.
- Age 30 years or older.
- Positive double, local comparative anesthetic diagnostic block injections at one unilateral or bilateral joint(s).
- Active or remote history of spinal malignancy.
- Active infection.
- Blood dyscrasias/coagulopathy.
- Unwillingness to follow through with follow up evaluations.
- Negative response to all diagnostic facet joint injections.
- Application for/currently receiving worker’s compensation.
- Allergy to avian products.
- Allergy to prior viscosupplementation products.
- Improper intra-articular needle placement at time of Synvisc injection.
- Painful bilateral or multi-level facet joint arthropathy.
Michael J DePalma, (MD)
Sheltering Arms Spine and Sport Center
St. Mary’s Hospital
United States, 23226