Effectiveness of Facet Joint Infiltration in Low Back Pain

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2011 by Federal University of São Paulo.
Recruitment status was Not yet recruiting

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:

MedlinePlus related topics: Back Pain

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

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, see Learn About Clinical Studies.

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 Nervous System Diseases	Neurologic Manifestations Pain Signs and Symptoms

ClinicalTrials.gov processed this record on February 27, 2015

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