NCT01447160

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3 low-back-pain

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_3 low-back-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

October 6, 2011

Status Verified

July 1, 2011

Enrollment Period

6 months

First QC Date

July 29, 2011

Last Update Submit

October 5, 2011

Conditions

Low Back Pain

Keywords

facet jointback painosteoarthritisinfiltration

Outcome Measures

Primary Outcomes (4)

  • pain visual analogic scale

    pain visual scale graduated from zero to ten

    baseline

  • pain visual analogic scale

    pain visual analogic scale graduated 0--10

    4 weeks

  • pain visual analogic scale

    pain visual analogic scale graduated 0--10

    12 weeks

  • pain visual analogic scale

    pain visual analogic scale graduated 0--10

    24 weeks

Secondary Outcomes (8)

  • Rolland Morris questionnaire

    baseline

  • Rolland Morris questionnaire

    4 weeks

  • Rolland Morris questionnaire

    12 weeks

  • Rolland Morris questionnaire

    24 weeks

  • SF-36 questionnaire

    baseline

  • +3 more secondary outcomes

Study Arms (2)

facet joint infiltration

EXPERIMENTAL

The experimental group will be submitted to intra-articular infiltration of six facet joints (L3/L4;L4/L5;L5/S1 bilaterally) with triamcinolone hexacetonide

Drug: Cortisone

intramuscular injection

ACTIVE COMPARATOR

The control group which were submitted to triamcinolone acetonide intramuscular injection of six lumbar paravertebral points

Drug: Cortisone

Interventions

CortisoneDRUG

intraarticular infiltration with 1ml of triamcinolone hexacetonide versus intramuscular injection with 1 ml of triamcinolone acetonide

facet joint infiltrationintramuscular injection

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • low back pain up to 3 months
  • pain on back extension
  • radiologic findings of facet joint osteoarthritis

You may not qualify if:

  • other causes of back pain
  • fibromyalgia
  • diabetes, arterial hypertension or glaucoma not well controlled
  • patients with contrast allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sao Paulo federal University

São Paulo, São Paulo, 04023-062, Brazil

Location

MeSH Terms

Conditions

Low Back PainBack PainOsteoarthritis

Interventions

Cortisone

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

PregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds17-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Luiza Ribeiro, doctor

    Sao Paulo Federal University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

luiza ribeiro, doctor

CONTACT

55-11 92678027luizahcr@hotmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 29, 2011

First Posted

October 6, 2011

Study Start

October 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

October 6, 2011

Record last verified: 2011-07

Locations

BR(1)