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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
  Purpose

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.


Condition Intervention Phase
Low Back Pain
 Drug: Cortisone
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Facet Joint Infiltration in Low Back Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 60
Study Start Date: October 2011
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01447160

Contacts
Contact: luiza ribeiro, doctor 55-11 92678027 luizahcr@hotmail.com

Locations
Brazil
Sao Paulo federal University Not yet recruiting
Sao Paulo, SP, Brazil, 04023-062
Principal Investigator: Luiza Ribeiro, doctor            
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Luiza Ribeiro, doctor Sao Paulo Federal University
  More Information

No publications provided

Responsible Party: Federal University os Sao Paulo, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01447160     History of Changes
Other Study ID Numbers: FUSao Paulo
Study First Received: July 29, 2011
Last Updated: October 5, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
facet joint
back pain
osteoarthritis
infiltration

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Triamcinolone hexacetonide
Cortisone
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
 Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013