Synvisc Injections for Lumbar Facet Joint Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Sheltering Arms Physical Rehabilitation Hospitals.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Genzyme, a Sanofi Company
Virginia Commonwealth University
Information provided by:
Sheltering Arms Physical Rehabilitation Hospitals
ClinicalTrials.gov Identifier:
NCT00325845
First received: May 12, 2006
Last updated: September 12, 2006
Last verified: September 2006
  Purpose

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.


Condition Intervention Phase
Joint Pain
Procedure: Synvisc viscosupplementation
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Intra-Articular Synvisc Injections as Treatment of Painful Lumbar Facet Joint Arthrosis

Resource links provided by NLM:


Further study details as provided by Sheltering Arms Physical Rehabilitation Hospitals:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Analgesic usage
  • Lumbar range of motion
  • Patient satisfaction

Estimated Enrollment: 15
Study Start Date: May 2006
Estimated Study Completion Date: May 2008
Detailed Description:

Patients will enter the study once the putatively painful joint or joints have been confirmed by single blind, double local-comparative anesthetic blockade. The joint(s) suspected by historical features and physical examination will be injected under fluoroscopic guidance with contrast-enhancement confirming intra-articular placement. The initial injectate will be 1cc of 2% xylocaine. Single diagnostic lumbar facet joint injections carry a false positive rate of 38%. In order to maximize the specificity of the diagnostic injections a second 1cc injection of a longer-acting local anesthetic, 0.5% marcaine, will be performed on all patients reporting clinically significant pain reduction (> 75% VAS reduction from pre-injection baseline) within 10-15 minutes after the xylocaine injection. This second diagnostic injection will be completed upon return of the patient’s pain back to baseline (no sooner than 3 days after the initial diagnostic injection). A true positive response will be defined as > 50% VAS reduction after the second injection. Patients will then undergo 2 IA Synvisc injections into the painful facet joint(s). An initial IA injection of 1.0cc (or a volume, not to exceed 1.0cc, accepted by the joint upon reaching a capsular endpoint) of Synvisc (1cc, 10mg/ml) will be injected into the painful joint(s) 7 days after the second diagnostic injection after the baseline pain has returned. A 2nd injection will then be performed 10 days after the initial injection. A 3rd injection may be offered to patients not satisfied with the results obtained with the first 2 Synvisc injections. A 2.0cc vial of Synvisc per patient will be shipped including other trial materials to the investigator for implementation. A fluid dispenser connector will allow direct dispensation of 1.0cc of Synvisc from the pre-packaged 2.0cc unmarked vial. Outcome measurement tools will include Visual Analogue Scale, Oswestry Disability Questionnaire, SF-36, lumbar spine range of motion (ROM), sitting and walking tolerance, analgesic usage, and patient satisfaction. Data will be collected at baseline, at 7-10 days after the second Synvisc injection, and at 1, 3, 6, and 12 month follow up (after the final Synvisc injection) visits. For example, patient X will undergo an initial 2 Synvisc injections and then be evaluated in the office 7 days later. If the patient experiences significant benefit, no other injections will be pursued. However, if a therapeutic benefit is achieved but is not satisfactory to the patient, a 3rd Synvisc injection will be performed within 3 days. A side effect and complications questionnaire will be completed by each patient within 30 minutes, 24 hours, and 72 hours after each injection (including diagnostic injections).

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00325845

Contacts
Contact: Michael J DePalma, MD 804-723-3244 depalmamj8@yahoo.com

Locations
United States, Virginia
Sheltering Arms Spine and Sport Center; St. Mary's Hospital Recruiting
Richmond, Virginia, United States, 23226
Principal Investigator: Michael J DePalma, MD         
Sponsors and Collaborators
Sheltering Arms Physical Rehabilitation Hospitals
Genzyme, a Sanofi Company
Virginia Commonwealth University
Investigators
Principal Investigator: Michael J DePalma, MD Sheltering Arms Physical Rehabilitation Hospitals; Virginia Commonwealth University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00325845     History of Changes
Other Study ID Numbers: G050253
Study First Received: May 12, 2006
Last Updated: September 12, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Sheltering Arms Physical Rehabilitation Hospitals:
Investigational
Therapeutic
Efficacy
Safety
Outcomes
Lumbar facet joint arthrosis
Lumbar facet joint arthropathy

Additional relevant MeSH terms:
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 29, 2014