Synvisc Injections for Lumbar Facet Joint Pain

September 12, 2006 updated by: Sheltering Arms Physical Rehabilitation Hospitals

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23226
        • Recruiting
        • Sheltering Arms Spine and Sport Center; St. Mary's Hospital
        • Principal Investigator:
          • Michael J DePalma, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Patient satisfaction
Analgesic usage
Lumbar range of motion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sheltering Arms Physical Rehabilitation Hospitals

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Genzyme, a Sanofi Company
Virginia Commonwealth University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael J DePalma, MD, Sheltering Arms Physical Rehabilitation Hospitals; Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2006

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2006

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2006

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • G050253

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Joint Pain

Clinical Trials on Synvisc viscosupplementation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings