Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00325845
Status:
UNKNOWN
Last Update Posted:
2006-09-13
First Post:
2006-05-12
Brief Title:
Synvisc Injections for Lumbar Facet Joint Pain
Sponsor:
Sheltering Arms Physical Rehabilitation Hospitals
Organization:
Sheltering Arms Physical Rehabilitation Hospitals
Study Overview
Official Title:
Efficacy and Safety of Intra-Articular Synvisc Injections as Treatment of Painful Lumbar Facet Joint Arthrosis
Status:
UNKNOWN
Status Verified Date:
2006-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 joints 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 05 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 patients 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 joints An initial IA injection of 10cc or a volume not to exceed 10cc accepted by the joint upon reaching a capsular endpoint of Synvisc 1cc 10mgml will be injected into the painful joints 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 20cc 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 10cc of Synvisc from the pre-packaged 20cc 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None