Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-03 @ 4:12 PM
Study NCT ID:
NCT01447160
Status:
UNKNOWN
Last Update Posted:
2011-10-06
First Post:
2011-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Facet Joint Infiltration in Low Back Pain
Sponsor:
Federal University of São Paulo
Organization:
Study Overview
Official Title:
Effectiveness of Facet Joint Infiltration in Low Back Pain
Status:
UNKNOWN
Status Verified Date:
2011-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the effectiveness of facet joint infiltration with corticosteroids in the treatment of low back pain due to facet joint osteoarthritis.
Detailed Description:
Sixty subjects with diagnostic of facet joint syndrome will be enrolled in the study.
They were randomized into experimental and control groups. The experimental group will be submitted to intra-articular infiltration of six facet joints. The control group will be submitted to intramuscular injection of six lumbar paravertebral points. After the randomization, all subjects will be assessed by an investigator blinded to the groups. The assessment will be taken just before the interventions (T0) and them 7 , 30 , 90 and 180 days after the interventions. The following assessment instruments will be used: pain visual analogical scale (VAS) (0-10cm), pain visual analogical scale during extension of the spine (VAS E) (0-10cm), Likert scale for improving (0-5), percentage scale of subjective improving perception(0-100%), Rolland-Morris questionnaire (0-24), short health survey questionnaire (SF36), accountability of medications taken for back pain: analgesics and non-steroidal antiinflammatories (NSAIDs).
They were randomized into experimental and control groups. The experimental group will be submitted to intra-articular infiltration of six facet joints. The control group will be submitted to intramuscular injection of six lumbar paravertebral points. After the randomization, all subjects will be assessed by an investigator blinded to the groups. The assessment will be taken just before the interventions (T0) and them 7 , 30 , 90 and 180 days after the interventions. The following assessment instruments will be used: pain visual analogical scale (VAS) (0-10cm), pain visual analogical scale during extension of the spine (VAS E) (0-10cm), Likert scale for improving (0-5), percentage scale of subjective improving perception(0-100%), Rolland-Morris questionnaire (0-24), short health survey questionnaire (SF36), accountability of medications taken for back pain: analgesics and non-steroidal antiinflammatories (NSAIDs).
Study Oversight
Has Oversight DMC:
False
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?: