We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of Facet Joint Infiltration in Low Back Pain

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by Federal University of São Paulo.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01447160
First Posted: October 6, 2011
Last Update Posted: October 6, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Federal University of São Paulo
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Facet Joint Infiltration in Low Back Pain

Resource links provided by NLM:


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

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

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

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

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


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

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

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

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

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

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

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

  • SF-36 questionnaire [ Time Frame: 24 weeks ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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

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 Submitted: July 29, 2011
First Posted: October 6, 2011
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