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Effectiveness of Facet Joint Infiltration in Low Back Pain

This study is not yet open for participant recruitment.
Verified July 2011 by Federal University of São Paulo
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01447160
First received: July 29, 2011
Last updated: October 5, 2011
Last verified: July 2011
History of Changes

July 29, 2011
October 5, 2011
October 2011
April 2012   (final data collection date for primary outcome measure)
  • pain visual analogic scale [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
    pain visual scale graduated from zero to ten
  • pain visual analogic scale [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    pain visual analogic scale graduated 0--10
  • pain visual analogic scale [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    pain visual analogic scale graduated 0--10
  • pain visual analogic scale [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    pain visual analogic scale graduated 0--10
Same as current
Complete list of historical versions of study NCT01447160 on ClinicalTrials.gov Archive Site
  • Rolland Morris questionnaire [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
    assess functional capacity
  • Rolland Morris questionnaire [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    assess functional capacity
  • Rolland Morris questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    assess functional capacity
  • Rolland Morris questionnaire [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    assess functional capacity
  • SF-36 questionnaire [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
    assess quality of life
  • SF-36 questionnaire [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    assess quality of life
  • SF-36 questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    assess quality of life
  • SF-36 questionnaire [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    assess quality of life
Same as current
Not Provided
Not Provided
 
Effectiveness of Facet Joint Infiltration in Low Back Pain
Effectiveness of Facet Joint Infiltration in Low Back Pain

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.

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).
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Low Back Pain
Drug: Cortisone
intraarticular infiltration with 1ml of triamcinolone hexacetonide versus intramuscular injection with 1 ml of triamcinolone acetonide
  • 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
    Intervention: Drug: Cortisone
  • Active Comparator: intramuscular injection
    The control group which were submitted to triamcinolone acetonide intramuscular injection of six lumbar paravertebral points
    Intervention: Drug: Cortisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: luiza ribeiro, doctor 55-11 92678027 luizahcr@hotmail.com
Brazil
 
NCT01447160
FUSao Paulo
No
Federal University os Sao Paulo, Federal University of São Paulo
Federal University of São Paulo
Not Provided
Principal Investigator: Luiza Ribeiro, doctor Sao Paulo Federal University
Federal University of São Paulo
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP