Synvisc Injections for Lumbar Facet Joint Pain

NCT ID: NCT00325845

Last Updated: 2006-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2008-05-31

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.

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).

Conditions

Joint Pain

Keywords

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Synvisc viscosupplementation

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: collaborator

Sheltering Arms Physical Rehabilitation Hospitals

OTHER

Sponsor Role: lead

Principal Investigators

Michael J DePalma, MD

Role: PRINCIPAL_INVESTIGATOR

Sheltering Arms Physical Rehabilitation Hospitals; Virginia Commonwealth University

Locations

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

Richmond, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michael J DePalma, MD

Role: CONTACT

Phone: 804-723-3244

Email: depalmamj8@yahoo.com

Other Identifiers

G050253

Identifier Type: -

Identifier Source: org_study_id