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.

Official Title

Efficacy and Safety of Intra-Articular Synvisc Injections as Treatment of Painful Lumbar Facet Joint Arthrosis.

Conditions

Study Type

Interventional

Study Design

Treatment, Non-Randomised, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study.

Further Details

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

Study Start

May 2006

Eligibility & Criteria

  • Ages Eligible for Study: 30 Years and older
  • Genders Eligible for Study: Both
  • Accepts Healthy Volunteers: No

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  • Improper intra-articular needle placement at time of Synvisc injection.
  • Painful bilateral or multi-level facet joint arthropathy.

Total Enrolment

15

Contact Details

Michael J DePalma, (MD)
804-723-3244
depalmamj8@yahoo.com

Location: 

Sheltering Arms Spine and Sport Center
St. Mary’s Hospital
Richmond, Virginia
United States, 23226