Effectiveness of Facet Joint Infiltration in Low Back Pain

Low Back Pain Clinical Trial

Official title:

Effectiveness of Facet Joint Infiltration in Low Back Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01447160
• Other study ID #: FUSao Paulo
• Status: Not yet recruiting
• Phase: Phase 3
• First received: July 29, 2011
• Last updated: October 5, 2011
• Start date: October 2011
• Est. completion date: April 2012

Study information

• Verified date: July 2011
• Source: Federal University of São Paulo
• Contact: luiza ribeiro, doctor
• Phone: 55-11 92678027
• Email: luizahcr[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Drug:
• Cortisone
intraarticular infiltration with 1ml of triamcinolone hexacetonide versus intramuscular injection with 1 ml of triamcinolone acetonide

Locations

Country	Name	City	State
Brazil	Sao Paulo federal University	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain visual analogic scale	pain visual scale graduated from zero to ten	baseline	Yes
Primary	pain visual analogic scale	pain visual analogic scale graduated 0--10	4 weeks	Yes
Primary	pain visual analogic scale	pain visual analogic scale graduated 0--10	12 weeks	Yes
Primary	pain visual analogic scale	pain visual analogic scale graduated 0--10	24 weeks	Yes
Secondary	Rolland Morris questionnaire	assess functional capacity	baseline	Yes
Secondary	Rolland Morris questionnaire	assess functional capacity	4 weeks	Yes
Secondary	Rolland Morris questionnaire	assess functional capacity	12 weeks	Yes
Secondary	Rolland Morris questionnaire	assess functional capacity	24 weeks	Yes
Secondary	SF-36 questionnaire	assess quality of life	baseline	Yes
Secondary	SF-36 questionnaire	assess quality of life	4 weeks	Yes
Secondary	SF-36 questionnaire	assess quality of life	12 weeks	Yes
Secondary	SF-36 questionnaire	assess quality of life	24 weeks	Yes