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Effectiveness of Facet Joint Infiltration in Low Back Pain

Effectiveness of Facet Joint Infiltration in Low Back Pain

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01447160
Enrollment
60
Registered
2011-10-06
Start date
2011-10-31
Completion date
2012-04-30
Last updated
2011-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

facet joint, back pain, osteoarthritis, infiltration

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.

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).

Interventions

intraarticular infiltration with 1ml of triamcinolone hexacetonide versus intramuscular injection with 1 ml of triamcinolone acetonide

Sponsors

Federal University of São Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
pain visual analogic scalebaselinepain visual scale graduated from zero to ten

Secondary

MeasureTime frameDescription
Rolland Morris questionnairebaselineassess functional capacity
SF-36 questionnairebaselineassess quality of life

Countries

Brazil

Contacts

Primary Contactluiza ribeiro, doctor
luizahcr@hotmail.com55-11 92678027

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026