Clinical Trials Directory

Trials / Unknown

UnknownNCT01447160

Effectiveness of Facet Joint Infiltration in Low Back Pain

Status
Unknown
Phase
Phase 3
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Federal University of São Paulo · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
DRUGCortisoneintraarticular infiltration with 1ml of triamcinolone hexacetonide versus intramuscular injection with 1 ml of triamcinolone acetonide

Timeline

Start date
2011-10-01
Primary completion
2012-04-01
Completion
2012-04-01
First posted
2011-10-06
Last updated
2011-10-06

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT01447160. Inclusion in this directory is not an endorsement.