Recruiting
Phase 3

Synvisc

Sponsor:

Sheltering Arms Physical Rehabilitation Hospitals

Code:

NCT00325845

Conditions

Joint Pain

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

Interventions

Synvisc viscosupplementation

Study Details

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.

Conditions

Joint Pain

Study ID

NCT00325845

Start date

May, 2006

Status verified date

Sep, 2006

Completion date

May, 2008

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

15 participants

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Synvisc viscosupplementation

Primary outcome measure

  • Visual Analogue Scale (VAS) for baseline pain (best, worst, average) and pain while walking [ Time Frame: undefined ]
  • Oswestry Disability Questionnaire [ Time Frame: undefined ]
  • Short Form 36-Item (SF-36) [ Time Frame: undefined ]
  • Standing/walking tolerance (defined as time patient can sit for before pain level reaches baseline or distance walked before pain reaches baseline) [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Michael J DePalma, MD

804-723-3244depalmamj8@yahoo.com

Locations

Sheltering Arms Spine and Sport Center; St. Mary's Hospital

Recruiting

Richmond, Virginia, United States, 23226

Principal Investigator:

Michael J DePalma, MD

More Information

Sponsor

Sheltering Arms Physical Rehabilitation Hospitals

Last update posted

Sep 13, 2006

Last verified

Sep, 2006

Keywords

  • Investigational
  • Therapeutic
  • Efficacy
  • Safety
  • Outcomes
  • Lumbar facet joint arthrosis
  • Lumbar facet joint arthropathy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sheltering Arms Physical Rehabilitation Hospitals on 2006-09-13.