Synvisc Injections for Lumbar Facet Joint Pain

Status unconfirmed · Phase 3

Conditions studied: Joint Pain

In brief

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.

Key facts

Study ID

NCT00325845

Run by

Sheltering Arms Physical Rehabilitation Hospitals

People needed

15

Starts

2006-05-01

Expected to finish

2008-05-01

Last updated by the study team

2006-09-13

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Sheltering Arms Spine and Sport Center; St. Mary's Hospital — Richmond, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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