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Effectiveness of Facet Joint Infiltration in Low Back Pain

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ClinicalTrials.gov Identifier: NCT01447160
Recruitment Status : Unknown
Verified July 2011 by Federal University of São Paulo.
Recruitment status was:  Not yet recruiting
First Posted : October 6, 2011
Last Update Posted : October 6, 2011
Sponsor:
Information provided by:
Federal University of São Paulo

Study Description
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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.

Condition or disease Intervention/treatment Phase
Low Back Pain Drug: Cortisone Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Facet Joint Infiltration in Low Back Pain
Study Start Date : October 2011
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. pain visual analogic scale [ Time Frame: baseline ]
    pain visual scale graduated from zero to ten

  2. pain visual analogic scale [ Time Frame: 4 weeks ]
    pain visual analogic scale graduated 0--10

  3. pain visual analogic scale [ Time Frame: 12 weeks ]
    pain visual analogic scale graduated 0--10

  4. pain visual analogic scale [ Time Frame: 24 weeks ]
    pain visual analogic scale graduated 0--10


Secondary Outcome Measures :
  1. Rolland Morris questionnaire [ Time Frame: baseline ]
    assess functional capacity

  2. Rolland Morris questionnaire [ Time Frame: 4 weeks ]
    assess functional capacity

  3. Rolland Morris questionnaire [ Time Frame: 12 weeks ]
    assess functional capacity

  4. Rolland Morris questionnaire [ Time Frame: 24 weeks ]
    assess functional capacity

  5. SF-36 questionnaire [ Time Frame: baseline ]
    assess quality of life

  6. SF-36 questionnaire [ Time Frame: 4 weeks ]
    assess quality of life

  7. SF-36 questionnaire [ Time Frame: 12 weeks ]
    assess quality of life

  8. SF-36 questionnaire [ Time Frame: 24 weeks ]
    assess quality of life


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: October 6, 2011    Key Record Dates
Last Update Posted: October 6, 2011
Last Verified: July 2011

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
Triamcinolone
Triamcinolone Acetonide
Cortisone
 Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action