Joint Pain | Synvisc Injections for Lumbar Facet Joint Pain
Joint Pain research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: 1. Ongoing axial lumbar pain, greater than any lower limb pain if present, for > 3 months duration. 2. No improvement despite 6-8 weeks of physical therapy (PT), oral nonsteroidal anti-inflammatory drugs (NSAIDs), relative rest, and activity modification. 3. 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. 4. Age 30 years or older. 5. Positive double, local comparative anesthetic diagnostic block injections at one unilateral or bilateral joint(s). Exclusion Criteria: 1. Pregnancy. 2. Active or remote history of spinal malignancy. 3. Active infection. 4. Blood dyscrasias/coagulopathy. 5. Unwillingness to follow through with follow up evaluations. 6. Negative response to all diagnostic facet joint injections. 7. Application for/currently receiving worker’s compensation. 8. Allergy to avian products. 9. Allergy to prior viscosupplementation products. 10. Prior viscosupplementation of lumbar facet joints. 11. Improper intra-articular needle placement at time of Synvisc injection. 12. Painful bilateral or multi-level facet joint arthropathy.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: May 2006
Completed Date: May 2008
Phase: Phase 3
Primary Outcome: Visual Analogue Scale (VAS) for baseline pain (best, worst, average) and pain while walking
Secondary Outcome: Analgesic usage
Study sponsors, principal investigator, and references
Principal Investigator: Michael J DePalma, MD
Lead Sponsor: Sheltering Arms Physical Rehabilitation Hospitals
Collaborator: Genzyme, a Sanofi Company