Effectiveness of Facet Joint Infiltration in Low Back Pain

Sponsor

Federal University of São Paulo (Other)

Overall Status

Unknown status

CT.gov ID

NCT01447160

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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 :

Oct 1, 2011

Anticipated Primary Completion Date :

Apr 1, 2012

Anticipated Study Completion Date :

Apr 1, 2012

Arms and Interventions

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

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

Primary Outcome Measures

pain visual analogic scale [baseline]
pain visual scale graduated from zero to ten
pain visual analogic scale [4 weeks]
pain visual analogic scale graduated 0--10
pain visual analogic scale [12 weeks]
pain visual analogic scale graduated 0--10
pain visual analogic scale [24 weeks]
pain visual analogic scale graduated 0--10

Secondary Outcome Measures

Rolland Morris questionnaire [baseline]
assess functional capacity
Rolland Morris questionnaire [4 weeks]
assess functional capacity
Rolland Morris questionnaire [12 weeks]
assess functional capacity
Rolland Morris questionnaire [24 weeks]
assess functional capacity
SF-36 questionnaire [baseline]
assess quality of life
SF-36 questionnaire [4 weeks]
assess quality of life
SF-36 questionnaire [12 weeks]
assess quality of life
SF-36 questionnaire [24 weeks]
assess quality of life

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Sao Paulo federal University	Sao Paulo	SP	Brazil	04023-062

Sponsors and Collaborators

Federal University of São Paulo

Investigators

Principal Investigator: Luiza Ribeiro, doctor, Sao Paulo Federal University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01447160

Other Study ID Numbers:

FUSao Paulo

First Posted:

Oct 6, 2011

Last Update Posted:

Oct 6, 2011

Last Verified:

Jul 1, 2011

Keywords provided by , ,

Additional relevant MeSH terms:

Back Pain

Low Back Pain

Cortisone

Study Results

No Results Posted as of Oct 6, 2011