Synvisc Injections for Lumbar Facet Joint Pain
Efficacy and Safety of Intra-Articular Synvisc Injections as Treatment of Painful Lumbar Facet Joint Arthrosis
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 12, 2006
CompletedFirst Posted
Study publicly available on registry
May 15, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedSeptember 13, 2006
September 1, 2006
May 12, 2006
September 12, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (3)
Analgesic usage
Lumbar range of motion
Patient satisfaction
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Pregnancy.
- 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.
- Prior viscosupplementation of lumbar facet joints.
- Improper intra-articular needle placement at time of Synvisc injection.
- Painful bilateral or multi-level facet joint arthropathy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sheltering Arms Physical Rehabilitation Hospitalslead
- Genzyme, a Sanofi Companycollaborator
- Virginia Commonwealth Universitycollaborator
Study Sites (1)
Sheltering Arms Spine and Sport Center; St. Mary's Hospital
Richmond, Virginia, 23226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael J DePalma, MD
Sheltering Arms Physical Rehabilitation Hospitals; Virginia Commonwealth University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 12, 2006
First Posted
May 15, 2006
Study Start
May 1, 2006
Study Completion
May 1, 2008
Last Updated
September 13, 2006
Record last verified: 2006-09