Effectiveness of Facet Joint Infiltration in Low Back Pain
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ClinicalTrials.gov Identifier: NCT01447160 |
Recruitment Status
: Unknown
Verified July 2011 by Federal University of São Paulo.
Recruitment status was: Not yet recruiting
First Posted
: October 6, 2011
Last Update Posted
: October 6, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Low Back Pain | Drug: Cortisone | Phase 3 |
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 (Clinical Trial) |
Estimated 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 : | October 2011 |
Estimated Primary Completion Date : | April 2012 |
Estimated Study Completion Date : | April 2012 |

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
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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
|
- pain visual analogic scale [ Time Frame: baseline ]pain visual scale graduated from zero to ten
- pain visual analogic scale [ Time Frame: 4 weeks ]pain visual analogic scale graduated 0--10
- pain visual analogic scale [ Time Frame: 12 weeks ]pain visual analogic scale graduated 0--10
- pain visual analogic scale [ Time Frame: 24 weeks ]pain visual analogic scale graduated 0--10
- Rolland Morris questionnaire [ Time Frame: baseline ]assess functional capacity
- Rolland Morris questionnaire [ Time Frame: 4 weeks ]assess functional capacity
- Rolland Morris questionnaire [ Time Frame: 12 weeks ]assess functional capacity
- Rolland Morris questionnaire [ Time Frame: 24 weeks ]assess functional capacity
- SF-36 questionnaire [ Time Frame: baseline ]assess quality of life
- SF-36 questionnaire [ Time Frame: 4 weeks ]assess quality of life
- SF-36 questionnaire [ Time Frame: 12 weeks ]assess quality of life
- SF-36 questionnaire [ Time Frame: 24 weeks ]assess quality of life

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01447160
Contact: luiza ribeiro, doctor | 55-11 92678027 | luizahcr@hotmail.com |
Brazil | |
Sao Paulo federal University | Not yet recruiting |
Sao Paulo, SP, Brazil, 04023-062 | |
Principal Investigator: Luiza Ribeiro, doctor |
Principal Investigator: | Luiza Ribeiro, doctor | Sao Paulo Federal University |
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 |
First Posted: | October 6, 2011 Key Record Dates |
Last Update Posted: | October 6, 2011 |
Last Verified: | July 2011 |
Keywords provided by Federal University of São Paulo:
facet joint back pain osteoarthritis infiltration |
Additional relevant MeSH terms:
Back Pain Low Back Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Triamcinolone hexacetonide Triamcinolone Triamcinolone Acetonide Cortisone |
Triamcinolone diacetate Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |