Effectiveness of Facet Joint Infiltration in Low Back Pain

October 5, 2011 updated by: Federal University of São Paulo
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • 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 Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 04023-062
        • Sao Paulo Federal University

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

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: facet joint infiltration
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
intraarticular infiltration with 1ml of triamcinolone hexacetonide versus intramuscular injection with 1 ml of triamcinolone acetonide
Active Comparator: intramuscular injection
The control group which were submitted to triamcinolone acetonide intramuscular injection of six lumbar paravertebral points
Drug: Cortisone
intraarticular infiltration with 1ml of triamcinolone hexacetonide versus intramuscular injection with 1 ml of triamcinolone acetonide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain visual analogic scale
Time Frame: baseline
pain visual scale graduated from zero to ten
baseline
pain visual analogic scale
Time Frame: 4 weeks
pain visual analogic scale graduated 0--10
4 weeks
pain visual analogic scale
Time Frame: 12 weeks
pain visual analogic scale graduated 0--10
12 weeks
pain visual analogic scale
Time Frame: 24 weeks
pain visual analogic scale graduated 0--10
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rolland Morris questionnaire
Time Frame: baseline
assess functional capacity
baseline
Rolland Morris questionnaire
Time Frame: 4 weeks
assess functional capacity
4 weeks
Rolland Morris questionnaire
Time Frame: 12 weeks
assess functional capacity
12 weeks
Rolland Morris questionnaire
Time Frame: 24 weeks
assess functional capacity
24 weeks
SF-36 questionnaire
Time Frame: baseline
assess quality of life
baseline
SF-36 questionnaire
Time Frame: 4 weeks
assess quality of life
4 weeks
SF-36 questionnaire
Time Frame: 12 weeks
assess quality of life
12 weeks
SF-36 questionnaire
Time Frame: 24 weeks
assess quality of life
24 weeks

Collaborators and Investigators

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

Sponsor

Federal University of São Paulo

Investigators

  • Principal Investigator: Luiza Ribeiro, doctor, Sao Paulo Federal 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

October 1, 2011

Primary Completion (Anticipated)

April 1, 2012

Study Completion (Anticipated)

April 1, 2012

Study Registration Dates

First Submitted

July 29, 2011

First Submitted That Met QC Criteria

October 5, 2011

First Posted (Estimate)

October 6, 2011

Study Record Updates

Last Update Posted (Estimate)

October 6, 2011

Last Update Submitted That Met QC Criteria

October 5, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUSao Paulo

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.

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