Effectiveness of Facet Joint Infiltration in Low Back Pain

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.

Study Overview

• Status: Unknown
• Conditions: Low Back Pain
• Intervention / Treatment: Drug: Cortisone

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 04023-062
      • Sao Paulo Federal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain visual analogic scale	pain visual scale graduated from zero to ten	baseline
pain visual analogic scale	pain visual analogic scale graduated 0--10	4 weeks
pain visual analogic scale	pain visual analogic scale graduated 0--10	12 weeks
pain visual analogic scale	pain visual analogic scale graduated 0--10	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rolland Morris questionnaire	assess functional capacity	baseline
Rolland Morris questionnaire	assess functional capacity	4 weeks
Rolland Morris questionnaire	assess functional capacity	12 weeks
Rolland Morris questionnaire	assess functional capacity	24 weeks
SF-36 questionnaire	assess quality of life	baseline
SF-36 questionnaire	assess quality of life	4 weeks
SF-36 questionnaire	assess quality of life	12 weeks
SF-36 questionnaire	assess quality of life	24 weeks

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Investigators: Principal Investigator: Luiza Ribeiro, doctor, Sao Paulo Federal University

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Anticipated): April 1, 2012
• Study Completion (Anticipated): April 1, 2012

Study Registration Dates

• First Submitted: July 29, 2011
• First Submitted That Met QC Criteria: October 5, 2011
• First Posted (Estimate): October 6, 2011

Study Record Updates

• Last Update Posted (Estimate): October 6, 2011
• Last Update Submitted That Met QC Criteria: October 5, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: osteoarthritis; back pain; infiltration; facet joint
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Anti-Inflammatory Agents; Cortisone
• Other Study ID Numbers: FUSao Paulo